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1.
Artigo em Inglês | MEDLINE | ID: mdl-33826205

RESUMO

BACKGROUND: Stroke and aphasia can have a profound impact on people's lives, and depression is a common, frequently persistent consequence. Social networks also suffer, with poor social support associated with worse recovery. It is essential to support psychosocial well-being post-stroke, and examine which factors facilitate successful adjustment to living with aphasia. AIMS: In the context of a feasibility randomized controlled trial of peer-befriending (SUPERB), this qualitative study explores adjustment for people with aphasia in the post-acute phase of recovery, a phase often neglected in previous research. METHODS & PROCEDURES: Semi-structured interviews were conducted with 20 people with aphasia and 10 significant others, who were purposively sampled from the wider group of 56 people with aphasia and 48 significant others. Interviews took place in participants' homes; they were analysed using framework analysis. OUTCOMES & RESULTS: Participants with aphasia were 10 women and 10 men; their median (interquartile range-IQR) age was 70 (57.5-77.0) years. Twelve participants had mild aphasia, eight moderate-severe aphasia. Significant others were six women and four men with a median (IQR) age of 70.5 (43-79) years. They identified a range of factors that influenced adjustment to aphasia post-stroke. Some were personal resources, including mood and emotions; identity/sense of self; attitude and outlook; faith and spirituality; and moving forward. Significant others also talked about the impact of becoming carers. Other factors were external sources of support, including familial and other relationships; doctors, nurses and hospital communication; life on the ward; therapies and therapists; psychological support, stroke groups; and community and socializing. CONCLUSIONS & IMPLICATIONS: To promote adjustment in the acute phase, hospital staff should prioritize the humanizing aspects of care provision. In the post-acute phase, clinicians play an integral role in supporting adjustment and can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy. What this paper adds What is already known on the subject Anxiety and depression are common consequences of stroke, with depression rates high at 33% at 1 year post-onset. There is evidence that the psychological needs of people with aphasia are even greater than those of the general stroke population. Social support and social networks are also negatively impacted. Few studies have examined adjustment when people are still in hospital or in the early stages of post-stroke life in the community (< 6 months). Further, many stroke studies exclude people with aphasia. What this paper adds to existing knowledge Adjustment to living with stroke and aphasia begins in the early stages of recovery. While this partly depends on personal resources, many factors depend on external sources of help and support. These include doctors, nurses and hospital communication, their experience of life on the ward, and their therapists' person-centred care. What are the potential or actual clinical implications of this work? Clinicians play an integral role in facilitating people with aphasia to utilize their personal resources and support systems to adjust to life after stroke. They can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy.

2.
Trials ; 22(1): 267, 2021 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-33838678

RESUMO

OBJECTIVES: The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families' mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children's behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. TRIAL DESIGN: SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort - Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). PARTICIPANTS: Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. INTERVENTION AND COMPARATOR: Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children's behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. MAIN OUTCOMES: Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. RANDOMISATION: Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. BLINDING (MASKING): It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. TRIAL STATUS: V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1st April 2021. Anticipated end date for recruitment: 31st July 2021. TRIAL REGISTRATION: Clinicaltrial.gov: NCT04786080 . The trial was prospectively registered on 8 March 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

3.
JAMA Dermatol ; 157(4): 413-420, 2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33656512

RESUMO

Importance: The emerging paradigm of treat-to-target in psoriasis requires accurate monitoring of treatment response. The commonly used physician global assessment tool does not capture the patient's perception of their disease. Patient assessments facilitate shared decision-making and foster patient-centered care; however, recent research reports a discordance between patient- and physician-reported psoriasis severity. Understanding the factors underlying this discordance may improve treatment satisfaction and disease outcomes. Objectives: To evaluate the discordance between patient- and physician-reported measures of psoriasis severity and assess the association with patient mental health status. Design, Setting, and Participants: A cohort study using repeated cross-sectional analysis of real-world longitudinal data was conducted at a large specialist psoriasis service serving London and Southeast England. A total of 502 patients attending the psoriasis service between May 12, 2016, and November 1, 2018, were included. Data analysis was conducted July 22 to October 22, 2019. Main Outcomes and Measures: Psoriasis severity was assessed on each visit with identical 5-point physician and patient global assessment scales (clear/nearly clear, mild, moderate, severe, and very severe). Each patient completed validated self-report screens for depression and anxiety on each visit. Results: Longitudinal data from 502 individuals with psoriasis (1985 total observations) were available. A total of 339 patients (68%) were men, 396 (79%) were White, mean (SD) age was 47 (13) years, and 197 patients (39%) had concurrent psoriatic arthritis, 43 (9%) screened positive for depression, and 49 (10%) screened positive for anxiety. There was discordance between physician and patient measures of disease severity in 768 of 1985 office appointments (39%); on 511 visits (26%) patients rated their psoriasis as less severe and on 257 visits (13%) patients rated their psoriasis as more severe compared with their physician. Individuals who screened positive for depression or anxiety were more likely to overestimate their psoriasis severity compared with their physician (relative risk ratio: depression, 2.7; 95% CI, 1.6-4.5; anxiety, 2.1; 95% CI, 1.3-3.4). These findings remained statistically significant after adjustment for age, ethnicity, sex, body mass index, smoking, number of comorbidities, treatment modality, and presence of psoriatic arthritis. Conclusions and Relevance: The findings of this cohort study suggest that discordance between patient and physician assessments of psoriasis severity is associated with patients' mental health status. Recognition of anxiety and depression in individuals with psoriasis appears to be important when interpreting patient-reported outcome measures and informing appropriate treatment decisions.

4.
Arch Sex Behav ; 50(3): 925-959, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33689086

RESUMO

Evidence suggests that sexual minorities (e.g., those identifying as lesbian, gay, or bisexual) experience increased rates of depression compared to heterosexual individuals. Minority stress theory suggests that this disparity is due to stigma experienced by sexual minorities. Stigma processes are proposed to contribute to reduced coping/support resources and increased vulnerability processes for mental health problems. This review provided a systematic examination of research assessing the evidence for mediating factors that help explain such disparities. A literature search was conducted using the databases PubMed, PsycINFO, and Web of Science. The review included 40 identified studies that examined mediators of sexual minority status and depressive outcomes using a between-group design (i.e., heterosexual versus sexual minority participants). Studies of adolescents and adult samples were both included. The most common findings were consistent with the suggestion that stressors such as victimization, harassment, abuse, and increased stress, as well as lower social and family support, may contribute to differing depression rates in sexual minority compared to heterosexual individuals. Differences in psychological processes such as self-esteem and rumination may also play a role but have had insufficient research attention so far. However, caution is needed because many papers had important methodological shortcomings such as the use of cross-sectional designs, inferior statistical analyses for mediation, or measures that had not been properly validated. Although firm conclusions cannot be drawn, the current evidence base highlights many factors potentially suitable for further exploration in high-quality longitudinal research or randomized studies intervening with the potential mediators.

5.
Clin Rehabil ; : 269215521995671, 2021 Feb 24.
Artigo em Inglês | MEDLINE | ID: mdl-33624514

RESUMO

OBJECTIVE: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. DESIGN: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. PARTICIPANTS AND SETTING: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. INTERVENTION: Six 1-hour peer-befriending visits over three months. MAIN MEASURES: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. RESULTS: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, -2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated. CONCLUSIONS: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial.Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke.

6.
J Med Internet Res ; 22(11): e18691, 2020 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-33216002

RESUMO

BACKGROUND: Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT. OBJECTIVE: Nested within a randomized controlled trial of telephone- and web-delivered CBT for refractory IBS, this qualitative study aims to identify barriers to and facilitators of engagement over time with the interventions, identify social and psychological processes of change, and provide insight into trial results. METHODS: A longitudinal qualitative study was nested in a randomized controlled trial. Repeated semistructured interviews were conducted at 3 (n=34) and 12 months (n=25) post baseline. Participants received telephone-based CBT (TCBT; n=17 at 3 months and n=13 at 12 months) or web-based CBT (WCBT; n=17 at 3 months and n=12 at 12 months). Inductive thematic analysis was used to analyze the data. RESULTS: Participants viewed CBT as credible for IBS, perceived their therapists as knowledgeable and supportive, and liked the flexibility of web-based and telephone-based delivery; these factors facilitated engagement. Potential barriers to engagement in both groups (mostly overcome by our participants) included initial skepticism and concerns about the biopsychosocial nature of CBT, initial concerns about telephone-delivered talking therapy, challenges of maintaining motivation and self-discipline given already busy lives, and finding nothing new in the WCBT (WCBT group only). Participants described helpful changes in their understanding of IBS, attitudes toward IBS, ability to recognize IBS patterns, and IBS-related behaviors. Consistent with the trial results, participants described lasting positive effects on their symptoms, work, and social lives. Reasons and remedies for some attenuation of effects were identified. CONCLUSIONS: Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life. These forms of CBT may broaden access to CBT for IBS.

7.
BMJ Open ; 10(5): e035905, 2020 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-32448796

RESUMO

INTRODUCTION: The Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool. METHODS AND ANALYSIS: The study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial. ETHICS AND DISSEMINATION: The study has received National Health Service ethical approval from the London-Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment. TRIAL REGISTRATION NUMBER: NCT03628027.

8.
Behav Res Ther ; 128: 103594, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32272288

RESUMO

The supportive adjustment for multiple sclerosis (saMS) randomised controlled trial showed cognitive behavioural therapy (CBT) reduced distress at 12-months compared to supportive listening (SL). Larger changes in distress and functional impairment following CBT occurred in participants with clinical distress at baseline. This secondary analysis investigates whether CBT treatment effects occur through pre-defined CBT mechanisms of change in the total cohort and clinically distressed subgroup. 94 participants were randomised to saMS CBT or SL. Primary outcomes were distress and functional impairment (12 months). Mediators included cognitive-behavioural variables at post-treatment (15 weeks). Structural equation mediation and mediated-moderation models adjusting for baseline confounders assessed mediation overall and by distress level. Significant mediation was found but only for those with clinical distress at baseline. Illness acceptance (-0.20, 95% confidence interval -0.01 to -0.46) and reduced embarrassment avoidance behaviours (-0.22, -0.02 to -0.58) mediated CBT's effect on distress. Changes in beliefs about processing emotions (-0.19, -0.001 to -0.46) mediated CBT's effect on functional impairment. saMS CBT had effects on distress and functional impairment via some of the hypothesised mechanisms drawn from a theoretical model of adjustment for MS but only among participants with clinical distress at baseline. Increasing acceptance and emotional expression and decreasing embarrassment avoidance improves MS adjustment.

9.
Contemp Clin Trials Commun ; 17: 100506, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31909291

RESUMO

The majority of people receiving treatment for their heroin addiction, are prescribed methadone; for which there is an extensive evidence base. When treatment starts, people take their daily dose of methadone under supervision at a community pharmacy. Supervision guarantees methadone is taken as directed by the individual for whom it has been prescribed, helps to ensure individuals take their correct dose every day, and safeguards against diversion and overdose. However, individuals often fail to attend the pharmacy to take their methadone. Each missed dose is of concern. If a patient misses their daily dose of methadone, they will start to experience opiate withdrawal and cravings and are more likely to use heroin. If they miss three days dose, there are concerns that they may lose tolerance to the drug and may be at risk of overdose when the next dose is taken. Hence there is an urgent need to develop effective interventions for medication adherence. Research suggests that incentive-based medication adherence interventions may be very effective, but there are few controlled trials and the provision of incentives requires time and organisational systems which can be challenging in pharmacies. The investigators have developed the technology to deliver incentives by mobile telephone. This cluster randomised trial will test the feasibility of conducting a future trial evaluating the clinical and cost effectiveness of using telephone delivered incentives (praise and modest financial rewards via text messaging) to encourage adherence with supervised consumption of methadone in community pharmacies. Three drug services (each with two or three community pharmacies supervising methadone consumption that will enrol 20 individuals, a total of 60 participants) will be recruited and randomly allocated to deliver either i) telephone delivered incentives, ii) telephone delivered reminders or iii) no telephone system. Acceptability, recruitment, follow-up, and suitable measures of clinical and cost effectiveness will be assessed. Findings from this feasibility study will be assessed against stated progression criteria and used to inform a future confirmatory trial of the clinical and cost effectiveness of telephone delivered incentives to encourage medication adherence. Trial registration: ISRCTN58958179 (retrospectively registered).

10.
Behav Res Ther ; 123: 103503, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31715324

RESUMO

BACKGROUND: Anxiety and depression are common, debilitating and costly. These disorders are influenced by multiple risk factors, from genes to psychological vulnerabilities and environmental stressors, but research is hampered by a lack of sufficiently large comprehensive studies. We are recruiting 40,000 individuals with lifetime depression or anxiety and broad assessment of risks to facilitate future research. METHODS: The Genetic Links to Anxiety and Depression (GLAD) Study (www.gladstudy.org.uk) recruits individuals with depression or anxiety into the NIHR Mental Health BioResource. Participants invited to join the study (via media campaigns) provide demographic, environmental and genetic data, and consent for medical record linkage and recontact. RESULTS: Online recruitment was effective; 42,531 participants consented and 27,776 completed the questionnaire by end of July 2019. Participants' questionnaire data identified very high rates of recurrent depression, severe anxiety, and comorbidity. Participants reported high rates of treatment receipt. The age profile of the sample is biased toward young adults, with higher recruitment of females and the more educated, especially at younger ages. DISCUSSION: This paper describes the study methodology and descriptive data for GLAD, which represents a large, recontactable resource that will enable future research into risks, outcomes, and treatment for anxiety and depression.


Assuntos
Ansiedade/genética , Depressão/genética , Seleção de Pacientes , Desenvolvimento de Programas/métodos , Adolescente , Adulto , Idade de Início , Idoso , Idoso de 80 Anos ou mais , Feminino , Genótipo , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Fenótipo , Transtornos Fóbicos/genética , Adulto Jovem
11.
BMJ Open ; 9(6): e030356, 2019 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-31209097

RESUMO

INTRODUCTION: Severe hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence. METHODS AND ANALYSIS: A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol. ETHICS AND DISSEMINATION: The protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups. TRIAL REGISTRATION NUMBER: NCY02940873; Pre-results.


Assuntos
Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Conhecimentos, Atitudes e Prática em Saúde , Hipoglicemia/induzido quimicamente , Hipoglicemia/diagnóstico , Insulina/efeitos adversos , Educação de Pacientes como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Hipoglicemia/prevenção & controle , Insulina/uso terapêutico , Educação de Pacientes como Assunto/métodos , Índice de Gravidade de Doença , Falha de Tratamento
12.
Transl Psychiatry ; 9(1): 150, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31123309

RESUMO

Major depressive disorder and the anxiety disorders are highly prevalent, disabling and moderately heritable. Depression and anxiety are also highly comorbid and have a strong genetic correlation (rg ≈ 1). Cognitive behavioural therapy is a leading evidence-based treatment but has variable outcomes. Currently, there are no strong predictors of outcome. Therapygenetics research aims to identify genetic predictors of prognosis following therapy. We performed genome-wide association meta-analyses of symptoms following cognitive behavioural therapy in adults with anxiety disorders (n = 972), adults with major depressive disorder (n = 832) and children with anxiety disorders (n = 920; meta-analysis n = 2724). We estimated the variance in therapy outcomes that could be explained by common genetic variants (h2SNP) and polygenic scoring was used to examine genetic associations between therapy outcomes and psychopathology, personality and learning. No single nucleotide polymorphisms were strongly associated with treatment outcomes. No significant estimate of h2SNP could be obtained, suggesting the heritability of therapy outcome is smaller than our analysis was powered to detect. Polygenic scoring failed to detect genetic overlap between therapy outcome and psychopathology, personality or learning. This study is the largest therapygenetics study to date. Results are consistent with previous, similarly powered genome-wide association studies of complex traits.


Assuntos
Transtornos de Ansiedade/genética , Transtornos de Ansiedade/terapia , Terapia Cognitivo-Comportamental/estatística & dados numéricos , Transtorno Depressivo Maior/genética , Transtorno Depressivo Maior/terapia , Estudo de Associação Genômica Ampla/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Adulto , Criança , Humanos
13.
Gut ; 68(9): 1613-1623, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-30971419

RESUMO

OBJECTIVE: To evaluate the clinical effectiveness of two modes of cognitive-behavioural therapy (CBT) for IBS compared with treatment as usual (TAU) in refractory IBS. DESIGN: A three-arm randomised controlled trial assessing telephone-delivered CBT (TCBT), web-based CBT (WCBT) with minimal therapist support, and TAU. Blinding participants and therapists was not possible. Chief investigator, assessors and statisticians were blinded. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and South of England between May 2014 to March 2016. Co-primary outcomes were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. RESULTS: 558/1452 (38.4%) patients screened for eligibility were randomised: 76% female: 91% white: mean age 43 years. (391/558) 70.1% completed 12 months of follow-up. Primary outcomes: Compared with TAU (IBS-SSS 205.6 at 12 months), IBS-SSS was 61.6 (95% CI 33.8 to 89.5) points lower (p<0.001) in TCBT and 35.2 (95% CI 12.6 to 57.8) points lower (p=0.002) in WCBT at 12 months. Compared with TAU (WSAS score 10.8 at 12 months) WSAS was 3.5 (95% CI 1.9 to 5.1) points lower (p<0.001) in TCBT and 3.0 (95% CI 1.3 to 4.6) points lower (p=0.001) in WCBT. All secondary outcomes showed significantly greater improvement (p≤0.002) in CBT arms compared with TAU. There were no serious adverse reactions to treatment. CONCLUSION: Both CBT interventions were superior to TAU up to 12 months of follow-up. TRIAL REGISTRATION NUMBER: ISRCTN44427879.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Internet , Síndrome do Intestino Irritável/terapia , Consulta Remota/métodos , Telefone , Adulto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente/estatística & dados numéricos , Índice de Gravidade de Doença , Resultado do Tratamento
14.
Behav Ther ; 50(3): 594-607, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31030876

RESUMO

Irritable bowel syndrome (IBS) is a functional gastrointestinal syndrome consisting of different bowel pattern subtypes: diarrhea predominant (IBS-D), constipation predominant (IBS-C), and alternating (IBS-A). This paper aimed to identify whether (a) psychological factors implicated in the cognitive behavioral model of IBS were differentially associated with bowel pattern subtypes, (b) whether there were differences in symptom severity and work and social adjustment across the IBS-subtypes. Analysis was conducted on baseline data of 557 individuals with refractory IBS recruited into the Assessing Cognitive Therapy in Irritable Bowel (ACTIB) randomized controlled trial. Correlations assessed the associations between psychological factors, stool patterns, symptom severity, and work and social adjustment. Hierarchical regressions identified whether cognitive and behavioral factors were significantly associated with frequency of loose/watery stools, hard/lumpy stools and symptom severity while controlling for affective (anxiety and depression) and demographic factors (age, gender, symptom duration). One-way ANOVAs were conducted to assess differences across Rome III classified subtypes (IBS-A, D and C) in cognitive, behavioral, affective, symptom severity, and adjustment measures. Psychological factors were significantly associated with symptom severity and work and social adjustment. Increased avoidance behavior and unhelpful gastrointestinal (GI) cognitions were significantly associated with higher frequency of loose/watery stools. Increased control behaviors were associated with higher frequency of hard/lumpy stools. Cognitive and behavioral differences were significant across the Rome III classified IBS subtypes. There were no differences in anxiety, depression, overall symptom severity, or work and social adjustment. The results are discussed in terms of their utility in tailoring cognitive behavioral treatments to IBS subtypes.


Assuntos
Aprendizagem da Esquiva/fisiologia , Cognição/fisiologia , Síndrome do Intestino Irritável/diagnóstico , Síndrome do Intestino Irritável/psicologia , Adulto , Ansiedade/diagnóstico , Ansiedade/psicologia , Ansiedade/terapia , Terapia Cognitivo-Comportamental/métodos , Constipação Intestinal/diagnóstico , Constipação Intestinal/psicologia , Constipação Intestinal/terapia , Estudos Transversais , Depressão/diagnóstico , Depressão/psicologia , Depressão/terapia , Diarreia/diagnóstico , Diarreia/psicologia , Diarreia/terapia , Feminino , Humanos , Síndrome do Intestino Irritável/terapia , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
15.
J Child Psychol Psychiatry ; 60(8): 888-896, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30907437

RESUMO

BACKGROUND: Retrospective and cross-sectional studies often report associations between childhood gender nonconformity and greater emotional and peer difficulties. This study used the ALSPAC birth cohort to investigate relationships between childhood gender-typed behavior and peer and emotional problems throughout childhood and adolescence. METHODS: A total of 11,192 participants had at least one measure of parent-rated gender-typed behavior in infancy; 7,049 participants had a measure of child-rated gender-typed behavior at 8.5 years. Separate linear mixed regression models were fitted to assess whether parent-rated and child-rated gender-typed behaviors were associated with emotional and peer problems across childhood and adolescence (6-16 years old). The effect of adding covariates (self-esteem, abuse, bullying, feeling accepted by peers, and feeling different) on these relationships was assessed. RESULTS: For boys, more gender-nonconforming behavior was associated with greater subsequent emotional and peer problems in childhood and adolescence. Adjusting for self-esteem, relational bullying victimization, feeling different, or feeling accepted by peers reduced some of these associations. In contrast, for girls, more gender-nonconforming behavior was associated with fewer emotional problems in childhood and adolescence. In girls, self-reported gender-nonconforming behavior was also associated with fewer parent-rated peer problems but parent-rated gender-nonconforming behavior was associated with more parent-rated peer problems; this latter association was partly explained by self-esteem, bullying, and abuse victimization. These associations were statistically significant but small. CONCLUSIONS: Overall, more female-typical behaviors were generally associated with greater subsequent emotional and peer problems, for both boys and girls. Future studies should investigate factors that reduced these associations, as well as potential negative effects of female-typical behaviors or advantages of male-typical ones. As this was a 14-year longitudinal study, the relationships between gender-role behaviors and emotional/peer problems warrant further research despite the small association sizes.


Assuntos
Comportamento do Adolescente/psicologia , Comportamento Infantil , Emoções/fisiologia , Identidade de Gênero , Relações Interpessoais , Grupo Associado , Conformidade Social , Adolescente , Criança , Feminino , Humanos , Estudos Longitudinais , Masculino , Reino Unido
16.
Trials ; 20(1): 131, 2019 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-30760305

RESUMO

BACKGROUND: There are enormous problems in recruiting depressed people into randomised controlled trials (RCTs), with numerous studies consistently failing to recruit to target (Sully et al., Trials 14:166, 2013). Given the high prevalence of-and disability associated with-depression, it is important to find ways of effectively recruiting to RCTs evaluating interventions. This study aimed to test the feasibility of using a self-referral system to recruit to a brief intervention in a multi-site trial, the CLASSIC trial of self-confidence workshops for depression. In that trial, participants referred themselves to a depression intervention with a positive non-diagnostic title of 'self-confidence', given the close relationship of depression and self-esteem (Horrell et al., Br J Psychiatry 204:222-233, 2014). METHOD: We analysed uptake and retention rates by recruitment to the study, attendance at the workshops and follow-up rates. However, because of the rapid rate of recruitment, we decided to pause the trial and revise our original single-site research protocol in months 5-6. We report findings under three main headings: recruitment rates for the 12 months of the project before and after the pause; data regarding attendance at the workshops before and after the pause; and the follow-up rates before and after the pause. RESULTS: We recruited 459 participants within 12 months, representing 38 participants recruited per month. Improved uptake of the intervention and retention after the development of multi-site research protocols are reported. DISCUSSION: Based on previous evidence from RCT recruitment among depressed participants, our recruitment rate demonstrates that a self-referral system using a non-diagnostic title of self-confidence is a successful recruitment method. The implications of rapid recruitment using a self-referral system are described, including the impact on uptake of the intervention as well as participant retention. Because of the potential for recruiting many participants quickly, research teams need to be adequately resourced and the oversight committees prepared to meet at shorter intervals with RCTs of brief interventions. SHORT CONCLUSION: Self-referral to a brief intervention for depression with a non-diagnostic title can be a very effective way of recruiting depressed people into trials. However, there are also some challenges. TRIAL REGISTRATION: ISRCTN, ISRCTN26634837 . Registered on 10 June 2010.


Assuntos
Depressão/terapia , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Autorreferência Médica , Projetos de Pesquisa , Autoimagem
17.
Artigo em Inglês | MEDLINE | ID: mdl-30693094

RESUMO

Background: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. Methods/design: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). Discussion: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. Trial registration: ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016.

18.
J Psychosom Res ; 118: 73-82, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30522750

RESUMO

BACKGROUND: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterised by abdominal pain and altered bowel movements. Cognitive behavioural therapy (CBT) has been shown to be effective in reducing symptom severity in IBS and enhancing quality of life/functioning. The present study sought to identify how CBT achieves change in these outcomes. METHOD: Secondary analysis was conducted on 149 patients with irritable bowel syndrome who had been randomised to cognitive behavioural therapy plus an antispasmodic medication or antispasmodic alone. Single and sequential mediation was modelled using structural equation modelling. Gastrointestinal (GI) related avoidance behaviour, safety behaviour, cognitions and general anxiety were included as mediators. RESULTS: GI safety behaviours, cognitions and general anxiety mediated treatment effect on the outcomes of symptom severity and work and social adjustment. Avoidance behaviour was not a significant mediator for either outcome. Sequential mediation models indicated that unhelpful GI related cognitions reduced before anxiety did, and this sequential path (R➔GI related cognitions➔anxiety➔outcome) was significant for both symptom severity (b = -0.22, CI [-0.40 to -0.90], p = .005) and work and social adjustment (b = -0.26, CI [-0.44 to -0.11], p = .003) where 'R' is randomisation. Reduction in GI safety behaviours also preceded reduction in anxiety. This sequence (R ➔GI safety behaviours➔anxiety➔outcome) was significant for both symptom severity (b = -0.11, CI [-0.24 to -0.01], p = .049) and work and social adjustment (b = -0.12, CI [-0.23 to -0.03], p = .03). CONCLUSION: Results suggest that it is important for psychological treatments to target IBS specific factors for change.


Assuntos
Ansiedade/psicologia , Cognição/fisiologia , Terapia Cognitivo-Comportamental/métodos , Comportamentos Relacionados com a Saúde/fisiologia , Síndrome do Intestino Irritável/terapia , Qualidade de Vida/psicologia , Adolescente , Adulto , Feminino , Humanos , Síndrome do Intestino Irritável/patologia , Masculino , Pessoa de Meia-Idade , Adulto Jovem
20.
Psychosom Med ; 80(2): 230-237, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29023262

RESUMO

OBJECTIVE: Symptoms of chronic fatigue syndrome (CFS) can be perpetuated by cognitive and behavioral responses to the illness. We aimed to determine the factor structure, reliability, and validity of the 40-item Cognitive and Behavioural Responses Questionnaire (CBRQ) using data gathered from CFS patients. We also propose a short-version CBRQ for greater clinical utility. METHODS: The psychometric analysis was performed on data sets drawn from two sources: a clinical service for CFS patients (n = 576) and the PACE randomized controlled trial of CFS treatments (n = 640). An exploratory factor analysis was conducted on the clinical data set and a confirmatory factor analysis was performed on the randomized controlled trial data set. Using these results, a short version of the CBRQ was proposed. Reliability, metric invariance across age and sex, and construct validity were assessed. RESULTS: The exploratory factor analysis (relative χ = 2.52, root mean square error of approximation = 0.051, comparative fit index = 0.964, Taylor-Lewis Index = 0.942) and confirmatory factor analysis (relative χ = 4.029, root mean square error of approximation = 0.069, comparative fit index = 0.901, Taylor-Lewis Index = 0.892) revealed that eight-factor models fitted the data well. Satisfactory Cronbach's α values were obtained for the final subscales (≥0.76). The shortened CBRQ was obtained by removing items that cross-loaded onto other factors and/or were the lowest loading items in each factor. The shortened CBRQ contained 18 items that had high factor loadings, good face validity, and reliability (Cronbach's α = 0.67-0.88). CONCLUSIONS: The CBRQs, long and short versions, are reliable and valid scales for measuring cognitive and behavioral responses of patients with CFS. Further research is needed to examine the utility of the CBRQ in other long-term conditions.


Assuntos
Escala de Avaliação Comportamental/normas , Síndrome de Fadiga Crônica/diagnóstico , Testes Neuropsicológicos/normas , Psicometria/normas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria/instrumentação , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Adulto Jovem
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