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1.
Prog Community Health Partnersh ; 18(1): 103-112, 2024.
Article En | MEDLINE | ID: mdl-38661831

BACKGROUND: Implementation of evidence-based interventions to reduce depression among uninsured Latinx patients who are at high risk of depression are rare. OBJECTIVES: Our goal was to evaluate Strong Minds, a language and culturally tailored, evidence-based intervention adapted from cognitive behavioral therapy (CBT) for mild-moderate depression and anxiety, delivered by community health workers (CHWs) in Spanish to uninsured Latinx immigrants. METHODS: As part of the pilot, 35 participants, recruited from a free community primary care clinic, completed Strong Minds. Assessments and poststudy interviews were conducted. Paired t-tests were used to assess change of depressive symptoms at 3 and 6 months. LESSONS LEARNED: CHW delivery of depression care to this population was feasible and among those who completed the program, preliminary evidence of depression outcomes suggests potential benefit. CHWs had specific training and support needs related to mental health care delivery. CONCLUSIONS: Further implementation studies of depression care interventions using CHWs for underserved Latinx is needed.


Community Health Workers , Depression , Hispanic or Latino , Medically Uninsured , Humans , Hispanic or Latino/psychology , Community Health Workers/organization & administration , Community Health Workers/psychology , Pilot Projects , Female , Male , Adult , Baltimore , Middle Aged , Depression/therapy , Depression/ethnology , Cognitive Behavioral Therapy/methods , Community-Based Participatory Research , Program Evaluation
2.
J Med Internet Res ; 26: e51558, 2024 Apr 05.
Article En | MEDLINE | ID: mdl-38578667

BACKGROUND: Virtual reality (VR) interventions, based on cognitive behavioral therapy principles, have been proven effective as complementary tools in managing obesity and have been associated with promoting healthy behaviors and addressing body image concerns. However, they have not fully addressed certain underlying causes of obesity, such as a lack of motivation to change, low self-efficacy, and the impact of weight stigma interiorization, which often impede treatment adherence and long-term lifestyle habit changes. To tackle these concerns, this study introduces the VR self-counseling paradigm, which incorporates embodiment and body-swapping techniques, along with motivational strategies, to help people living with obesity effectively address some of the root causes of their condition. OBJECTIVE: This study aims to assess the clinical efficacy of ConVRself (Virtual Reality self-talk), a VR platform that allows participants to engage in motivational self-conversations. METHODS: A randomized controlled trial was conducted with 68 participants from the bariatric surgery waiting list from the obesity unit of the Vall d'Hebron University Hospital in Barcelona, Spain. Participants were assigned to 1 of 3 groups: a control group (CG), which only received treatment as usual from the obesity unit; experimental group 1 (EG1), which, after intensive motivational interviewing training, engaged in 4 sessions of VR-based self-conversations with ConVRself, and underwent embodiment and body-swapping techniques; and experimental group 2 (EG2), which engaged in 4 VR-based sessions led by a virtual counselor with a prerecorded discourse, and only underwent the embodiment technique. In the case of both EG1 and EG2, the VR interventions were assisted by a clinical researcher. Readiness to change habits, eating habits, and psychological variables, as well as adherence and satisfaction with ConVRself were measured at baseline, after the intervention, 1 week after the intervention, and 4 weeks after the intervention. RESULTS: Regarding the primary outcomes, EG1 (24/68, 35%) and EG2 (22/68, 32%) showed significant improvements in confidence to lose weight compared to the CG (22/68, 32%) at all assessment points (ß=-.16; P=.02). Similarly, EG1 demonstrated a significant increase after the intervention in readiness to exercise more compared to the CG (ß=-.17; P=.03). Regarding the secondary outcomes, EG1 participants showed a significant reduction in uncontrolled eating (ß=.71; P=.01) and emotional eating (ß=.29; P=.03) compared to the CG participants, as well as in their anxiety levels compared to EG2 and CG participants (ß=.65; P=.01). In addition, participants from the experimental groups reported high adherence and satisfaction with the VR platform (EG1: mean 59.82, SD 4.00; EG2: mean 58.43, SD 5.22; d=0.30, 95% CI -0.30 to 0.89). CONCLUSIONS: This study revealed that using VR self-conversations, based on motivational interviewing principles, may have benefits in helping people with obesity to enhance their readiness to change habits and self-efficacy, as well as reduce dysfunctional eating behaviors and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05094557; https://www.clinicaltrials.gov/study/NCT05094557.


Cognitive Behavioral Therapy , Virtual Reality , Humans , Treatment Outcome , Obesity/therapy , Cognitive Behavioral Therapy/methods , Life Style
3.
JAMA Netw Open ; 7(4): e247361, 2024 Apr 01.
Article En | MEDLINE | ID: mdl-38652478

IMPORTANCE: Postoperative delirium is a common and impactful neuropsychiatric complication in patients undergoing coronary artery bypass grafting surgery. Cognitive training may enhance cognitive reserve, thereby reducing postoperative delirium. OBJECTIVE: To determine whether preoperative cognitive training reduces the incidence of delirium in patients undergoing coronary artery bypass grafting. DESIGN, SETTING, and PARTICIPANTS: This prospective, single-blind, randomized clinical trial was conducted at 3 university teaching hospitals in southeastern China with enrollment between April 2022 and May 2023. Eligible participants included those scheduled for elective coronary artery bypass grafting who consented and enrolled at least 10 days before surgery. INTERVENTIONS: Participating patients were randomly assigned 1:1, stratified by site, to either routine care or cognitive training, which included substantial practice with online tasks designed to enhance cognitive functions including memory, imagination, reasoning, reaction time, attention, and processing speed. MAIN OUTCOMES AND MEASURES: The primary outcome was occurrence of delirium during postoperative days 1 to 7 or until hospital discharge, diagnosed using the Confusion Assessment Method or the Confusion Assessment Method for Intensive Care Units. Secondary outcomes were postoperative cognitive dysfunction, delirium characteristics, and all-cause mortality within 30 days following the operation. RESULTS: A total of 218 patients were randomized and 208 (median [IQR] age, 66 [58-70] years; 64 female [30.8%] and 144 male [69.2%]) were included in final analysis, with 102 randomized to cognitive training and 106 randomized to routine care. Of all participants, 95 (45.7%) had only a primary school education and 54 (26.0%) had finished high school. In the cognitive training group, 28 participants (27.5%) developed delirium compared with 46 participants (43.4%) randomized to routine care. Those receiving cognitive training were 57% less likely to develop delirium compared with those receiving routine care (adjusted odds ratio [aOR] 0.43; 95% CI, 0.23-0.77; P = .007). Significant differences were observed in the incidence of severe delirium (aOR, 0.46; 95% CI, 0.25-0.82; P = .01), median (IQR) duration of delirium (0 [0-1] days for cognitive training vs 0 [0-2] days for routine care; P = .008), and median (IQR) number of delirium-positive days (0 [0-1] days for cognitive training vs 0 [0-2] days for routine care; P = .007). No other secondary outcomes differed significantly. CONCLUSIONS AND RELEVANCE: In this randomized trial of 208 patients undergoing coronary artery bypass grafting, preoperative cognitive training reduced the incidence of postoperative delirium. However, our primary analysis was based on fewer than 75 events and should therefore be considered exploratory and a basis for future larger trials. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2200058243.


Coronary Artery Bypass , Delirium , Postoperative Complications , Humans , Male , Female , Middle Aged , Aged , Delirium/prevention & control , Delirium/epidemiology , Delirium/etiology , Single-Blind Method , Prospective Studies , Postoperative Complications/prevention & control , Postoperative Complications/epidemiology , Coronary Artery Bypass/adverse effects , China/epidemiology , Cognitive Behavioral Therapy/methods , Cognitive Training
4.
BMJ Open ; 14(4): e081084, 2024 Apr 22.
Article En | MEDLINE | ID: mdl-38653511

INTRODUCTION: Cancer-related cognitive impairment is common among people diagnosed with and treated for cancer. This can be a distressing and disabling side effect for impacted individuals. Interventions to mitigate cognitive dysfunction are available, but, to date, most have been trialled in samples that are largely or exclusively composed of people with solid tumours. Intervention strategies to support cognitive functioning are needed, but there is a paucity of research in this area. The main aim of this study is to test the feasibility and acceptability of methods and procedures intended for use in a definitive trial of a web-based cognitive rehabilitation programme, Responding to Cognitive Concerns (eReCog), in people who have received chemotherapy for aggressive lymphoma. METHODS AND ANALYSIS: The proposed study is a single-site, parallel-group, pilot randomised controlled trial, with one baseline and one follow-up (or postintervention) assessment. 38 people from the target population with low perceived cognitive function based on the Cognitive Change Screen will be recruited from a specialist cancer centre between July 2023 and June 2024. After baseline assessment, participants will be randomised one-to-one to receive usual care only (a factsheet about changes in memory and thinking for people with cancer) or eReCog plus usual care. The 4-week eReCog intervention consists of four online modules offering psychoeducation on cognitive impairment associated with cancer and its treatment, skills training for improving memory, and attention and relaxation training. Study outcomes will include the feasibility of recruitment and retention at follow-up assessment (primary outcomes), as well as adherence to, usability of and intrinsic motivation to engage with eReCog, and compliance with study measures. The potential efficacy of eReCog will also be evaluated. ETHICS AND DISSEMINATION: Ethical approval was granted by the Peter MacCallum Cancer Centre Human Research Ethics Committee in Victoria, Australia (HREC/97384/PMCC). Study findings will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry, ACTRN12623000705684.


Internet-Based Intervention , Humans , Pilot Projects , Lymphoma/complications , Lymphoma/rehabilitation , Randomized Controlled Trials as Topic , Cognitive Dysfunction/etiology , Cognitive Dysfunction/rehabilitation , Cognitive Dysfunction/therapy , Feasibility Studies , Chemotherapy-Related Cognitive Impairment , Internet , Cognitive Behavioral Therapy/methods , Cognitive Training
5.
PLoS One ; 19(4): e0301675, 2024.
Article En | MEDLINE | ID: mdl-38568925

Transdiagnostic group cognitive behavioural therapy (TD-GCBT) is more effective in improving symptoms and severity of emotional disorders (EDs) than treatment as usual (TAU; usually pharmacological treatment). However, there is little research that has examined the effects of these treatments on specific symptoms. This study used Network Intervention Analysis (NIA) to investigate the direct and differential effects of TD-GCBT + TAU and TAU on specific symptoms of anxiety and depression. Data are from a multicentre randomised clinical trial (N = 1061) comparing TD-GCBT + TAU versus TAU alone for EDs. The networks included items from the PHQ-9 (depression) and GAD-7 (anxiety) questionnaire and mixed graphical models were estimated at pre-treatment, post-treatment and 3-, 6- and 12-month follow-up. Results revealed that TD-GCBT + TAU was associated with direct effects, mainly on several anxiety symptoms and depressed mood after treatment. New direct effects on other depressive symptoms emerged during the follow-up period promoted by TD-GCBT compared to TAU. Our results suggest that the improvement of anxiety symptoms after treatment might precipitate a wave of changes that favour a decrease in depressive symptomatology. NIA is a methodology that can provide fine-grained insight into the likely pathways through which treatments exert their effects.


Cognitive Behavioral Therapy , Humans , Anxiety/therapy , Anxiety Disorders/therapy , Cognitive Behavioral Therapy/methods , Depression/therapy , Mood Disorders , Treatment Outcome , Multicenter Studies as Topic , Randomized Controlled Trials as Topic
6.
Clin Psychol Psychother ; 31(2): e2973, 2024.
Article En | MEDLINE | ID: mdl-38572800

Metacognitive therapy (MCT) aims to modify dysfunctional metacognitions that are thought to be universal determinants of emotional distress and psychological dysfunction more generally. MCT is an effective treatment for emotional distress symptoms, but less is known about its effect for other types of psychological problems. Interpersonal problems are common in psychological disorders and should be improved following psychotherapy. Therefore, we conducted a systematic review and meta-analysis of trials on the effects associated with MCT for interpersonal problems among adults with mental health disorders published until 15 November 2023 using PubMed, Cochrane Library and PsycNet. Trials with a minimum of 10 participants were included. A total of six studies based on five trials reported on the effectiveness of MCT for interpersonal problems and met our inclusion criteria. Two trials evaluated MCT for patients with major depressive disorders, two for patients with anxiety disorders and one for borderline personality disorder. Three of the trials were randomized controlled trials. Four of the trials reported follow-up data but varied in their time-points. The within-group effect size estimate from pretreatment to posttreatment across five trials was large (g = 0.865, 95% CI [0.512-1.218]). Our results indicate that MCT is an effective treatment for improving interpersonal problems in individuals with common mental disorders, even though the treatment is short and primarily concern improving mental regulation through modifying metacognitions. While this finding is in line with metacognitive theory, more trials evaluating personality and interpersonal functioning are needed to draw firm conclusions.


Cognitive Behavioral Therapy , Depressive Disorder, Major , Metacognition , Adult , Humans , Cognitive Behavioral Therapy/methods , Psychotherapy/methods , Anxiety Disorders/therapy , Anxiety Disorders/psychology
7.
PLoS One ; 19(4): e0299803, 2024.
Article En | MEDLINE | ID: mdl-38625877

BACKGROUND: Anxiety disorders are common and debilitating which is why treatment is so important. According to the guidelines, Cognitive Behavioral Therapy (CBT) has the highest level of effectiveness among psychotherapeutic treatments and is the recommended procedure. However, not everyone responds well or at all to CBT which makes a wider range of therapy options valuable. Positive Psychotherapy (PPT) comes to mind as an alternative with its strength-based approach focusing on enhancing well-being and life satisfaction. Additionally, it has not yet been extensively studied how the processes that occur during treatment sessions and between treatment sessions effect treatment outcome. Thus, to lessen the lack of evidence regarding the efficacy of PPT as an anxiety treatment the planned study examines and compares the effectiveness of CBT and PPT as well as the effect of intrasession and intersession processes of the two therapy approaches. METHOD: The study is in the planning stage and consists of an efficacy and a process study. The efficacy study is a randomized controlled comparative study of patients with anxiety disorders (generalized anxiety disorder and/or panic disorder with or without agoraphobia) with two active treatment conditions (PPT and CBT) and a control group (CG; positive psychotherapy with minimal therapeutic supervision) in an online group setting. There are three measurement time points: before treatment begins (T0), at the end of the ten-week treatment (T1), and a follow-up after three months (T2). The aim of the study is to evaluate the efficacy of PPT and CBT in the treatment of anxiety disorders, and to compare the efficacy of online-based PPT with minimal therapeutic supervision and online-based PPT with intensive therapeutic supervision in the treatment of anxiety disorders. The process study will be used to evaluate both the intrasession processes and the intersession processes of the therapy in the two intervention groups. In addition, the process variables that predict the success of the therapy and the extent to which PPT and CBT differ in the therapy processes will be tested. The study is registered at the German Clinical Trial Register (№ DRKS00027521). DISCUSSION: To our knowledge, this is the first randomized controlled comparative study to examine the effectiveness of CBT and PPT for anxiety disorders in an online group setting.


Anxiety Disorders , Cognitive Behavioral Therapy , Humans , Anxiety Disorders/therapy , Psychotherapy , Anxiety/therapy , Cognitive Behavioral Therapy/methods , Agoraphobia/psychology , Treatment Outcome , Randomized Controlled Trials as Topic
8.
PLoS One ; 19(4): e0301606, 2024.
Article En | MEDLINE | ID: mdl-38625953

BACKGROUND: Prompt access to evidence-based treatment for children and young people with eating disorders is important for outcomes, yet the gap in service provision remains pervasive. Record levels of young people are waiting for eating disorder treatment and access to care is limited. Guided self-help interventions that are brief and require minimal clinician support have the potential to meet the unprecedented demand for treatment quickly and effectively. OBJECTIVE: To examine the feasibility, acceptability and proof of concept of a novel, CBT guided self-help intervention for children and young people with threshold and subthreshold eating disorders. METHODS: A single-arm, proof-of-concept pilot study of the CBT guided self-help intervention will be conducted. Children and young people (aged 11-19) with threshold and subthreshold eating disorders will receive a self-help intervention covering the core components of CBT, supported by 8 weekly guidance sessions delivered remotely. Clinical outcomes (eating-related psychopathology and associated impairment, changes in weight, depression, anxiety, and behavioural difficulties) will be assessed at baseline and post-intervention (12 weeks). Feasibility and acceptability of the intervention will be measured using various outcomes, including adherence to, and engagement with the intervention, rates of recruitment and retention, measure completion and treatment satisfaction. Qualitative data will also be collected for future intervention refinement. DISCUSSION: If the intervention is shown to produce clinical benefits in this pilot study, a fully powered randomised pilot study will be warranted with the ultimate goal of increasing access to psychological treatment for children and young people threshold and subthreshold eating disorders. ADMINISTRATIVE INFORMATION: This study protocol (S1 File) adheres to the guidelines outlined in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for trial protocols [1, 2] which can be found in S1 Checklist. The numbers in parentheses in this protocol correspond to the item numbers in the SPIRIT checklist. The order of items has been modified to group similar items.


Cognitive Behavioral Therapy , Feeding and Eating Disorders , Child , Humans , Adolescent , Pilot Projects , Cognitive Behavioral Therapy/methods , Anxiety , Self Care , Feeding and Eating Disorders/therapy , Randomized Controlled Trials as Topic
9.
Trials ; 25(1): 266, 2024 Apr 16.
Article En | MEDLINE | ID: mdl-38627837

BACKGROUND: About one third of patients with depression are in a condition that can be termed as "difficult-to-treat". Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently uncertain. The aim of this trial is to investigate the beneficial and harmful effects of 30 sessions of individual schema therapy versus treatment as usual for difficult-to-treat depression in the Danish secondary, public mental health sector. METHODS: In this randomized, multi-centre, parallel-group, superiority clinical trial, 129 outpatients with difficult-to-treat depression will be randomized (1:1) to 30 sessions of individual schema therapy or treatment as usual; in this context mainly group-based, short-term cognitive behaviour or psychodynamic therapy. The primary outcome is the change from baseline in depressive symptoms 12 months after randomization, measured on the observer-rated 6-item Hamilton Rating Scale for Depression. The secondary outcomes are health-related quality of life assessed with the European Quality of Life 5 Dimensions 5 Level Version, functional impairment assessed with the Work and Social Adjustment Scale, psychological wellbeing assessed with the WHO-5 Well-being Index, and negative effects of treatment assessed with the Negative Effects Questionnaire. Exploratory outcomes are improvement on patient self-defined outcomes, personal recovery, anxiety symptoms, anger reactions, metacognitive beliefs about anger, and perseverative negative thinking. Outcomes will be assessed at 6, 12, and 24 months after randomization; the 12-month time-point being the primary time-point of interest. Outcome assessors performing the depression-rating, data managers, statisticians, the data safety and monitoring committee, and conclusion makers for the outcome article will be blinded to treatment allocation and results. To assess cost-effectiveness of the intervention, a health economic analysis will be performed. DISCUSSION: This trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group. TRIAL REGISTRATION: ClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023).


Cognitive Behavioral Therapy , Depression , Humans , Depression/diagnosis , Depression/therapy , Cognitive Behavioral Therapy/methods , Outpatients , Schema Therapy , Quality of Life , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
10.
Eur J Psychotraumatol ; 15(1): 2335796, 2024.
Article En | MEDLINE | ID: mdl-38629400

Background: Sudden gains, defined as large and stable improvements of psychopathological symptoms, are a ubiquitous phenomenon in psychotherapy. They have been shown to occur across several clinical contexts and to be associated with better short-term and long-term treatment outcome. However, the approach of sudden gains has been criticized for its tautological character: sudden gains are included in the computation of treatment outcomes, ultimately resulting in a circular conclusion. Furthermore, some authors criticize sudden gains as merely being random fluctuations.Objective: Use of efficient methods to evaluate whether the amount of sudden gains in a given sample lies above chance level.Method: We used permutation tests in a sample of 85 patients with posttraumatic stress disorder (PTSD) treated with trauma-focused cognitive behaviour therapy in routine clinical care. Scores of self-reported PTSD symptom severity were permuted 10.000 times within sessions and between participants to receive a random distribution.Results: Altogether, 18 participants showed a total of 24 sudden gains within the first 20 sessions. The permutation test yielded that the frequency of sudden gains was not beyond chance level. No significant predictors of sudden gains were identified and sudden gains in general were not predictive of treatment outcome. However, subjects with early sudden gains had a significantly lower symptom severity after treatment.Conclusions: Our data suggest that a significant proportion of sudden gains are due to chance. Further research is needed on the differential effects of early and late sudden gains.


Treatment-related sudden gains exhibit clinical significance when their manifestation is above chance level.We used permutation tests to examine their occurrence in trauma-focused cognitive behaviour therapy as applied in a naturalistic treatment setting.The occurrence of sudden gains in general was not significantly higher than chance, yet early sudden gains were associated with improved treatment outcome.


Cognitive Behavioral Therapy , Stress Disorders, Post-Traumatic , Humans , Cognitive Behavioral Therapy/methods , Treatment Outcome , Psychotherapy , Stress Disorders, Post-Traumatic/diagnosis , Stress Disorders, Post-Traumatic/therapy , Stress Disorders, Post-Traumatic/psychology , Self Report
11.
J Prim Care Community Health ; 15: 21501319241241470, 2024.
Article En | MEDLINE | ID: mdl-38654523

BACKGROUND: Tobacco smoking exacerbates diabetes-related complications; its prevalence is notwithstanding substantial. Persons with diabetes face a number of barriers and challenges to quitting such as multiple lifestyle restrictions; tailored interventions are required for smoking cessation. OBJECTIVE: To identify research on behavioral interventions for smoking cessation in diabetes. METHODS: Studies had to be randomized controlled trials, quasiexperimental or systematic reviews. The behavioral interventions included were: the 5As, Cognitive-Behavioral Therapy, Motivational Interviewing, Contingency Management, Health Coaching and Counselling, as compared to standard care. The outcomes were self-reported and/or biochemically verified smoking cessation. CINAHL Complete, MEDLINE Complete, the Cochrane databases of systematic reviews and randomized controlled trials, PsychInfo and PubMed Central were searched until July, 2023. Keywords used included diabetes, smoking cessation and each of the behavioral interventions included. RESULTS: 1615 papers were identified. Three studies on the 5As/brief advice, 4 on Motivational Intervention and 1 on counseling were retained. The results on the 5As and Motivational Interviewing were conflicting. More intensive interventions appear to be more successful in achieving smoking cessation in smokers with diabetes. CONCLUSIONS: Future research should focus on the continued development and evaluation of structured smoking cessation interventions based on the 5As, Motivational interviewing and Cognitive Behavioral Therapy.


Behavior Therapy , Diabetes Mellitus , Smoking Cessation , Humans , Smoking Cessation/methods , Diabetes Mellitus/therapy , Behavior Therapy/methods , Motivational Interviewing/methods , Cognitive Behavioral Therapy/methods
12.
Trials ; 25(1): 246, 2024 Apr 09.
Article En | MEDLINE | ID: mdl-38594725

BACKGROUND: Insomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether it is sufficient to also address circadian issues in youths. In addition, despite that light has been shown to be effective in phase-shifting one's circadian rhythm, there has been limited data on the effects of bright light therapy and its combination with CBT-I on sleep and circadian outcomes in youths. The current protocol outlines a randomised controlled trial that examines the efficacy of CBT-I and CBT-I plus bright light therapy (BLT) in reducing insomnia severity, improving mood symptoms and daytime functioning (e.g. sleepiness, fatigue, cognitive function), and improving subjective and objective sleep and circadian measures compared to a waitlist control group. METHODS: We will carry out a randomised controlled trial (RCT) with 150 youths aged 12-24 who meet the criteria of insomnia and eveningness. Participants will be randomised into one of three groups: CBT-I with bright light therapy, CBT-I with placebo light, and waitlist control. Six sessions of CBT-I will be delivered in a group format, while participants will be currently asked to use a portable light device for 30 min daily immediately after awakening throughout the intervention period for bright light therapy. The CBT-I with light therapy group will receive bright constant green light (506 lx) while the CBT-I with placebo light group will receive the modified light device with the LEDs emitting less than 10 lx. All participants will be assessed at baseline and post-treatment, while the two active treatment groups will be additionally followed up at 1 month and 6 months post-intervention. The primary outcome will be insomnia severity, as measured by the Insomnia Severity Index. Secondary outcomes include self-reported mood, circadian, daytime functioning, and quality of life measures, as well as sleep parameters derived from actigraphy and sleep diary and neurocognitive assessments. Objective measures of the circadian phase using dim-light melatonin onset assessment and sleep parameters using polysomnography will also be included as the secondary outcomes. DISCUSSION: This study will be the first RCT to directly compare the effects of CBT-I and BLT in youths with insomnia and eveningness. Findings from the study will provide evidence to inform the clinical management of insomnia problems and eveningness in youths. TRIAL REGISTRATION: ClinicalTrials.gov NCT04256915. Registered on 5 February 2020.


Cognitive Behavioral Therapy , Sleep Disorders, Circadian Rhythm , Sleep Initiation and Maintenance Disorders , Humans , Adolescent , Sleep Initiation and Maintenance Disorders/diagnosis , Sleep Initiation and Maintenance Disorders/therapy , Sleep , Sleep Disorders, Circadian Rhythm/therapy , Phototherapy/methods , Cognitive Behavioral Therapy/methods , Treatment Outcome , Randomized Controlled Trials as Topic
13.
BMC Psychiatry ; 24(1): 265, 2024 Apr 09.
Article En | MEDLINE | ID: mdl-38594680

BACKGROUND: Adolescence is a crucial stage for the development of OCD symptoms that, in most cases, persist into adulthood. This requires designing preventive strategies tailored to this population. Therefore, we aim to describe the study protocol that will be used to examine the effectiveness of a mobile health application to challenge obsessional beliefs in adolescents. METHODS: A two-armed randomized controlled trial will be conducted on an adolescent sample from the general population. The experimental group will use the intervention module (GGOC-AD) of a mobile app on the GGtude platform for 14 days whereas the control group will use a non-active module (GGN-AD) of said app. Primary outcome measures will be obsessional beliefs and obsessive-compulsive symptoms, and secondary measures will be self-esteem and emotional symptoms. Three assessment points will be conducted at baseline, post-intervention, and one-month follow-up. A linear multiple regression model with an intention to treat approach will be used. The expected total sample size will be 55 participants. DISCUSSION: We expect that the intervention group will show a reduction in obsessional beliefs and OCD-symptoms at post and follow-up in comparison with the control group. Additionally, we expect that the app will improve participants' self-esteem. This study could provide an accessible mobile health tool to prevent OCD-related symptoms in adolescents. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06033391 . Registered September 4, 2023.


Cognitive Behavioral Therapy , Mobile Applications , Obsessive-Compulsive Disorder , Humans , Adolescent , Cognitive Behavioral Therapy/methods , Obsessive-Compulsive Disorder/therapy , Obsessive-Compulsive Disorder/psychology , Emotions , Multivariate Analysis , Randomized Controlled Trials as Topic
14.
BMC Psychol ; 12(1): 135, 2024 Mar 09.
Article En | MEDLINE | ID: mdl-38459602

BACKGROUND: Trauma-focused therapies (TFTs) are first-line treatments for posttraumatic stress disorder (PTSD). However, TFTs are under-utilised, partly due to clinicians' and patients' fear that TFT is too challenging or harmful. We review the qualitative studies on how adults with PTSD experience TFTs to enhance the understanding of user perspectives, therapeutic processes, and outcomes. METHODS: PubMed, PsychINFO and PTSDPubs were searched between October 1st and November 30th, 2021. Study quality assessments were undertaken, and studies were analysed using a descriptive-interpretative approach. Nine studies were included. RESULTS: The analysis resulted in the identification of four key domains, representing a temporal sequence of TFT stages: Overcoming ambivalence towards TFT, Experience of treatment elements, Motivation for dropout/retention, and Perceived changes post-treatment. CONCLUSION: Although many participants reported high levels of distress and considered dropping out, only a minority did eventually drop out and most patients expressed that the hardships in therapy were necessary for PTSD improvement. Establishing a safe therapeutic environment and working with the ambivalence towards treatment was essential for retention. This review serves a dual purpose, to shed light on diverse TFT experiences found to be important for treatment satisfaction, and to elucidate common treatment patterns. The results can be used in preparing patients for therapy and in training TFT therapists. Studies had moderate to high quality, and more studies of experiences of TFT non-responders and dropouts in a non-veteran population are needed to further our understanding of the utility and limitations of TFTs.


Cognitive Behavioral Therapy , Stress Disorders, Post-Traumatic , Adult , Humans , Stress Disorders, Post-Traumatic/therapy , Cognitive Behavioral Therapy/methods , Psychotherapy/methods , Affect , Fear
15.
Trials ; 25(1): 176, 2024 Mar 11.
Article En | MEDLINE | ID: mdl-38468293

INTRODUCTION: Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior to cognitive behavioral therapy (CBT) in reducing perceived limitations of movement. The current study aims to further compare the efficacy of both treatment methods and identify those patient groups that particularly benefit from EXP. METHODS: The general objective of this randomized multicenter clinical trial (targeted N = 380) is to improve and expand the range of treatments available to patients with chronic back pain. As the primary objective of the study, two different psychological treatments (EXP and CBT) will be compared. The primary outcome measure is a clinically significant improvement in pain-related impairment, measured by the QPBDS, from baseline to 6-month follow-up. Secondary outcome measures are absolute changes and clinically significant improvements in variables coping, psychological flexibility, depressiveness, catastrophizing, exercise avoidance and fear of exercise, and intensity of pain. Participants are recruited in five psychological and medical centers in Germany and receive ten sessions of manualized therapy by trained licensed CBT therapists or clinical psychologists, who are currently in their post-gradual CBT training. Potential predictors of each treatment's efficacy will be explored with a focus on avoidance and coping behavior. CONCLUSION: This study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it should gain more attention and be further disseminated. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294081. Registered on 02 March 2022.


Chronic Pain , Cognitive Behavioral Therapy , Humans , Pilot Projects , Back Pain/diagnosis , Back Pain/therapy , Back Pain/psychology , Cognitive Behavioral Therapy/methods , Fear , Costs and Cost Analysis , Chronic Pain/diagnosis , Chronic Pain/therapy , Chronic Pain/psychology , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
16.
J Affect Disord ; 355: 106-114, 2024 Jun 15.
Article En | MEDLINE | ID: mdl-38521133

BACKGROUND: Body dysmorphic disorder (BDD) is a severe, chronic disorder if untreated. Smartphone cognitive behavioral therapy (CBT) for BDD is efficacious and can reduce key treatment barriers (e.g., lack of clinicians, cost, stigma). While promising, little is known about who is more or less likely to benefit from this approach. METHODS: This is a secondary data analysis of a randomized, waitlist-controlled trial of smartphone CBT for BDD. Participants (N = 80) were recruited nationally and randomized to receive a 12-week, coach-guided CBT for BDD app, either immediately or after a 12-week waitlist. The main outcome for this analysis was BDD severity (BDD-YBOCS) over time (baseline, week 6, week 12) during the active app use phase in each randomized group (n = 74). Secondary outcomes included treatment response (≥30 % reduction in BDD-YBOCS) and remission (total BDD-YBOCS ≤16) at end-of-treatment. RESULTS: Immediate (vs. delayed) CBT predicted better outcomes (symptom improvement), as did gender identity (symptom improvement), higher baseline treatment credibility and expectancy (response, remission), lower baseline BDD severity (remission), and sexual minority status (vs. heterosexual; response, remission). LIMITATIONS: Limitations include the relatively small sample, drop-out rate of 22 %, and limited gender and racial-ethnic diversity. CONCLUSIONS: These results highlight a potential advantage of smartphone CBT in historically marginalized populations, and the importance of efforts to hasten treatment access, bolster confidence in the treatment at treatment onset, and develop stratified care models to optimize treatment allocation and efficacy.


Body Dysmorphic Disorders , Cognitive Behavioral Therapy , Humans , Male , Female , Treatment Outcome , Body Dysmorphic Disorders/therapy , Body Dysmorphic Disorders/psychology , Smartphone , Gender Identity , Cognitive Behavioral Therapy/methods
17.
Curr Med Res Opin ; 40(4): 689-699, 2024 04.
Article En | MEDLINE | ID: mdl-38465410

INTRODUCTION: Due to a dearth of evidence, we examined the effectiveness of brief-intensive CBT on symptom severity and catastrophic cognition in patients with panic disorder (PD). MATERIALS AND METHODS: In this randomized controlled trial, 155 patients were assigned to either the experimental group (2 successive days of brief-intensive CBT-3 h per day) or the control group (regular pharmacotherapy only). After excluding ineligible participants, 20 patients in the brief intensive CBT group and 18 patients in the control group completed the study and were included in the final analysis. The primary outcome was symptom severity, and the secondary outcome was catastrophic cognition, assessed by the Panic Disorder Severity Scale (PDSS) for symptoms severity and the Agoraphobic Cognition Scale (ACS) for cognitive assessment, respectively. RESULTS: The study showed that after one month of treatment, the PDSS (1.70 vs. 4.78; p = 0.0172) in the brief-intensive CBT group was significantly lower compared to the control group in contrast with the ACS (5.10 vs. 5.44; p = 0.8533). The mean score of PDSS and ACS significantly decreased from 21.60 to 1.7 (p < 0.0001) and from 22.55 to 5.10 (p < 0.0001) in the brief CBT group and from 19.44 to 4.78 (p < 0.0001) and 20.00 to 5.44 (p < 0.0001) in the control group, respectively. After treatment, the mean scores of PDSS and ACS significantly decreased in the brief intensive CBT and control groups. Both higher ACS and lower education levels contributed to higher PDSS in the brief intensive CBT group. However, only the PDSS correlated to the ACS in the control group. CONCLUSIONS: The study showed that brief-intensive CBT is an effective technique for reducing the severity of symptoms among PD patients. But, it was not effective to improve the cognitive level in PD patients at one month.


Cognitive Behavioral Therapy , Panic Disorder , Humans , Panic Disorder/therapy , Panic Disorder/diagnosis , Panic Disorder/psychology , Cognitive Behavioral Therapy/methods , Treatment Outcome
18.
Cogn Behav Ther ; 53(3): 324-350, 2024 05.
Article En | MEDLINE | ID: mdl-38483057

Perfectionism can be problematic when your self-worth is dependent on achievements and leads to inflexible standards, cognitive biases, and rigid behaviors. Cognitive behavior therapy for perfectionism is shown to be effective, including for targeting psychiatric symptoms and when delivered via the Internet (iCBT-P). However, few studies have compared it to an active comparator. The current study randomly assigned 138 participants seeking help for perfectionism to iCBT-P or Internet-based Unified Protocol (iUP). Both treatments provided guidance on demand from a therapist and were eight weeks in duration. The results indicated large within-group effects of Cohen's d 2.03 (iCBT) and 2.51 (iUP) on the Clinical Perfectionism Questionnaire at post-treatment, and maintained effects at 6- and 12-month follow-up, but no between-group difference (ß = 0.02, SE = 1.04, p = .98). Secondary outcomes of depression, anxiety, quality of life, self-compassion, procrastination, and stress ranged from small to large, with no differences between the conditions. Both treatments were deemed credible, relevant, of high quality, and well-adhered by the participants. Further research needs to be conducted, but the findings could indicate a lack of specificity, perhaps suggesting there is no need to differentiate between different treatments that are transdiagnostic in nature.


Cognitive Behavioral Therapy , Perfectionism , Humans , Quality of Life/psychology , Anxiety Disorders/therapy , Internet , Cognitive Behavioral Therapy/methods , Treatment Outcome
20.
J Affect Disord ; 355: 95-103, 2024 Jun 15.
Article En | MEDLINE | ID: mdl-38521137

BACKGROUND: Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. METHODS: This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. RESULTS: Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p = .886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = -7.217; p = .046; Cohens d = 0.33), but not depressive symptoms (B = -1.041; p = .607) than TAU. LIMITATIONS: The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. CONCLUSIONS: Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy.


Cognitive Behavioral Therapy , Crime Victims , Emotional Regulation , Adult , Humans , Depression/therapy , Depression/psychology , Psychotherapy/methods , Cognitive Behavioral Therapy/methods , Crime Victims/psychology , Treatment Outcome
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