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1.
BMC Psychiatry ; 24(1): 615, 2024 Sep 16.
Article in English | MEDLINE | ID: mdl-39285365

ABSTRACT

BACKGROUND: Mental health settings are increasingly using co-facilitation of educational group interventions in collaboration with patient partners and service users. However, despite promising results, limited information is available regarding the feasibility and satisfaction levels of these programmes among adults newly diagnosed with attention-deficit hyperactivity/impulsivity disorder (ADHD). Hence, this study aimed to determine the feasibility, acceptability, and preliminary effects of a user co-facilitated psychoeducational group programme for adults diagnosed with ADHD. METHODS: This feasibility proof-of-concept randomised controlled trial recruited outpatients from a Norwegian community mental health centre. Outpatients randomised to the intervention group (IG) received a psychoeducational programme supplementing Treatment As Usual (TAU), while the control group received TAU. Feasibility was determined by the acceptance rate, adherence rate, and dropout rate. Acceptability was measured with the Client Satisfaction Questionnaire and a 3-item scale measuring satisfaction with the received information. To test the preliminary effects, self-efficacy, symptom severity, and quality of life were measured at baseline and pre- and post-intervention. RESULTS: Feasibility was demonstrated; most of the patients were willing to enrol, participants attended 82% of the psychoeducational programme, and only 13% dropped out of the study. The between-group analyses revealed that the IG reported significantly greater mean satisfaction than the CG. Moreover, the intervention group was more satisfied with the information they received during the psychoeducational programme. Concerning the preliminary effects, the linear mixed model showed improvement in quality of life (the subscale relationship); however, other patient-reported outcomes did not show improvements. CONCLUSIONS: This proof-of-concept randomised controlled trial supports the feasibility and acceptability of the user co-facilitated psychoeducational programme for patients newly diagnosed with ADHD in an outpatient setting. While preliminary findings indicate promise in enhancing patient-reported outcomes, a larger study is warranted to assess the intervention's effectiveness rigorously. TRIAL REGISTRATION: NCT03425, 09/11/2017.


Subject(s)
Attention Deficit Disorder with Hyperactivity , Feasibility Studies , Patient Satisfaction , Proof of Concept Study , Humans , Female , Male , Adult , Attention Deficit Disorder with Hyperactivity/therapy , Attention Deficit Disorder with Hyperactivity/psychology , Patient Education as Topic/methods , Middle Aged , Patient Acceptance of Health Care/psychology , Quality of Life/psychology , Self Efficacy , Norway , Psychotherapy, Group/methods
2.
Stat Med ; 2024 Sep 03.
Article in English | MEDLINE | ID: mdl-39225281

ABSTRACT

Many individually randomized group treatment (IRGT) trials randomly assign individuals to study arms but deliver treatments via shared agents, such as therapists, surgeons, or trainers. Post-randomization interactions induce correlations in outcome measures between participants sharing the same agent. Agents can be nested in or crossed with trial arm, and participants may interact with a single agent or with multiple agents. These complications have led to ambiguity in choice of models but there have been no systematic efforts to identify appropriate analytic models for these study designs. To address this gap, we undertook a simulation study to examine the performance of candidate analytic models in the presence of complex clustering arising from multiple membership, single membership, and single agent settings, in both nested and crossed designs and for a continuous outcome. With nested designs, substantial type I error rate inflation was observed when analytic models did not account for multiple membership and when analytic model weights characterizing the association with multiple agents did not match the data generating mechanism. Conversely, analytic models for crossed designs generally maintained nominal type I error rates unless there was notable imbalance in the number of participants that interact with each agent.

3.
Article in English | MEDLINE | ID: mdl-39120778

ABSTRACT

Virtual clinical services became the primary treatment modality in a large U.S. HMO psychiatry department during the COVID-19 pandemic. A mixed methods quality improvement project was developed to address psychosis, severe anxiety, and stressors unique to COVID-19 and sheltering in place. The purpose was to determine if a virtual 10-week pilot program combining psychoeducation, skills-based training, experiential exercises using third-wave CBT, and process questions would decrease symptoms and hospitalization rates and improve quality of life. Pre- and postmeasure scores on pandemic-related stress (the PRSF), perceived stress (PSS), and general patient health (PHQ-9) were gathered from five patients in the Department of Psychiatry at Kaiser Permanente in Oakland, California. Qualitative interviews explored patients' perceptions of program benefits. Mean, median, and range on the pre- and postprogram assessments and paired samples t tests for means were calculated. Quantitative results were not statistically significant: p = 0.32 (Revised PRSF), p = 0.34 (PSS), p = 0.94 (PHQ-9). In interviews, most participants reported a decrease in pandemic-related stress. Half reported a decrease in general perceived stress. Half reported no change. Self-assessment reflected perceptions of benefits from this 10-week program, using words such as useful and important. The virtual program helped relieve pandemic-related stress and improved overall quality of life. The results show promise for expanding the program to other hospitals providing services for this diagnostic population.

4.
Br J Clin Psychol ; 2024 Jul 25.
Article in English | MEDLINE | ID: mdl-39054608

ABSTRACT

OBJECTIVE: Young people in care (i.e., in the child welfare system) are a group who have often experienced very high rates of potentially traumatic events, including maltreatment. It is well-documented that they have high rates of trauma-related mental health difficulties, such as posttraumatic stress. To address the needs of the large number of young people who may benefit from support, scalable interventions are crucial. But also important is that they are effective and deliverable - particularly given the complexity of this group and services. We assessed a five-session group CBT-based intervention for PTSD. The primary goal was to understand core procedural and protocol uncertainties to address prior to a definitive trial. METHODS: Participants were 34 10-17 year olds in care, with moderate to severe posttraumatic stress symptoms, and their caregiver. We ran seven groups (four online), delivered in social care and NHS-based mental health teams. Data were collected via pre-, post-, 3-month follow-up questionnaires and qualitative interviews. RESULTS: Of the 34 participants allocated to the intervention, 27 (80%) attended at least three of the five sessions (most attended all). Caregiver attendance was lower (50%). There was generally good completion of assessment measures. Qualitatively, most participants were positive about the intervention, and many reported improvements in areas such as coping, sleep, and willingness to talk about experiences. However, there were important concerns about the lack of ongoing support, given this was a low-intensity intervention for a group who often had complex needs. CONCLUSION: The intervention and research protocols were acceptable to most young people and carers. With modifications, a future definitive trial would likely be possible. However, key considerations include: how (and whether) to screen for PTSD; the trial design; and the option to embed high-intensity support (e.g., via assessing a stepped-care model).

5.
BMC Psychiatry ; 24(1): 361, 2024 May 14.
Article in English | MEDLINE | ID: mdl-38745158

ABSTRACT

BACKGROUND: A concentrated transdiagnostic and micro choice-based group treatment for patients with depression and anxiety has previously shown to yield significant reduction in symptoms and increased level of functioning from pre to 3-month follow-up. In the present study, we report the results after 12 months follow-up. METHODS: This was a non-randomized clinical intervention pilot study, conducted in line with a published protocol. Sixty-seven consecutively referred patients, aged 19-47 (mean age 32.5, SD = 8.0) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age at onset of symptoms was 17.6 (SD = 7.9) years. Mean number of prior treatment courses was 3.5 (SD = 3.3; range 0-20). The main objective was to assess the treatment effectiveness by questionnaires measuring relevant symptoms at pre-treatment, 7 days-, 3 months-, 6 months- and at 12-months follow-up. RESULTS: Validated measures of functional impairment (WSAS), depression (PHQ9), anxiety (GAD7), worry (PSWQ), fatigue (CFQ), insomnia (BIS) and illness perception (BIPQ) improved significantly (p < .0005) from before treatment to 12 months follow-up, yielding mostly large to extremely large effect sizes (0.89-3.68), whereas some moderate (0.60-0.76). After 12 months, 74% report an overall improvement in problems related to anxiety and depression. Utilization of specialist, public and private mental health care was reported as nonexistent or had decreased for 70% of the patients at 12-month follow up. CONCLUSIONS: The concentrated, micro-choice based group treatment approach yielded a highly clinically significant reduction in a wide range of symptoms already one week after treatment, and the positive results persisted at 12-month follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05234281, first posted date 10/02/2022.


Subject(s)
Psychotherapy, Group , Humans , Pilot Projects , Adult , Male , Female , Middle Aged , Psychotherapy, Group/methods , Young Adult , Treatment Outcome , Follow-Up Studies , Anxiety Disorders/therapy , Anxiety/therapy , Depression/therapy , Depressive Disorder/therapy
6.
Article in English | MEDLINE | ID: mdl-38764141

ABSTRACT

AIM: Young offenders experience higher rates of neurodevelopmental and mental health disorders than the general population, and significant access barriers to health treatment. Treatment combining Cognitive Remediation Therapy (CRT) and Social Cognition Remediation Therapy (SCRT) has demonstrated benefits for functional improvements and social development. However, there is limited information regarding group treatment programs in custodial settings for young offenders. This pilot study explores the effectiveness and feasibility of a group treatment program for youth offenders with cognitive deficits and mental health concerns in youth detention. METHODS: The School-Link Advantage pilot study designed and tested a 10-week group treatment program combining CRT and SCRT for young offenders in custody. The closed groups incorporated interactive activities focussed on emotional recognition and regulation skills, optimizing executive functioning, understanding values, exploring belief systems, improving relationships, and safety planning. RESULTS: Of the 22 male participants recruited in an Australian Youth Justice Centre, 12 completed all aspects of the treatment program, reflecting a 54.5% completion rate in a typically challenging to engage population cohort. Results demonstrated significant improvements in the ability to store and retrieve information, recognize information, and control emotions. Planning and organizing skills also showed considerable development. CONCLUSIONS: This pilot study suggests that a combined CRT and SCRT group treatment program has the potential to effectively target cognitive challenges associated with mental health disorders in young offenders in custody. These promising outcomes suggest exploring randomized controlled trials with increased cultural sensitivity for diverse populations.

7.
Int J Speech Lang Pathol ; : 1-16, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38692287

ABSTRACT

PURPOSE: We examined perceptual changes in the domains of ease of understanding, naturalness, and speech severity, as well as changes in self-perceptions of voice disability, following an online group speech treatment program for people with Parkinson's disease (PD) conducted during the COVID-19 pandemic. METHOD: Seven speakers with hypokinetic dysarthria associated with PD participated in a university and community-based online group speech program for 10 weeks. Speech recordings occurred remotely 1 week before and 1 week after the online program. Thirty naïve listeners rated ease of understanding, naturalness, and speech severity based on the speech recordings. Speakers' self-perceptions of voice disability were also obtained at both time points. RESULT: Individual analysis of the speech data showed that for most speakers with dysarthria, ease of understanding and perceptions of severity were rated the same or better pre- to post-treatment. Naturalness, however, was only perceived to be the same or better post-treatment in three out of seven speakers. Over half of the speakers reported improvements in their self-perception of voice disability. CONCLUSION: This pilot study highlighted the individual variability among speakers with dysarthria and the potential of online group speech treatment to maintain and/or improve speech function in this population.

8.
J Clin Med ; 13(7)2024 Apr 04.
Article in English | MEDLINE | ID: mdl-38610871

ABSTRACT

Background: The diagnostics and treatment of attention-deficit/hyperactivity disorder (ADHD) in women remain insufficient. Fluctuations of reproductive hormones during the premenstrual period, postpartum period, and (peri)menopause are neglected, even though they impact ADHD symptoms and associated mood disorders. Therefore, we created a female-specific treatment group for women with ADHD and premenstrual worsening of ADHD and/or mood symptoms. Methods: We describe the group programme and underlying rationale, offering a qualitative analysis of the participants' evaluation. Results: The seven bi-weekly sessions foreground the menstrual cycle and address several ADHD-specific topics in relation to this cyclical pattern. Concurrently, women track their menstrual cycle and (fluctuating) ADHD and mood symptoms with an adjusted premenstrual calendar. In total, 18 women (25-47 years) participated in three consecutive groups. We analysed the evaluation of the last group. Participants experienced the group as a safe and welcoming space. Recognition was valued by all. The topics discussed were deemed valuable, and the structure suited them well. Completing the premenstrual calendar augmented the awareness and recognition of individual cyclical symptoms. A lifespan approach increased self-understanding. Participants took their menstrual cycle more seriously, prioritising self-acceptance and self-care. Conclusions: Exploring a cyclical approach in a group setting seems to be a positive addition to treatment for female ADHD.

9.
Br J Pain ; 18(2): 155-165, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38545496

ABSTRACT

Introduction: Fibromyalgia (FM) is a disorder characterized by chronic pain, with significant medical, psychological, and socio-economic implications. Although there is limited evidence, cognitive-behavioral therapy (CBT) has shown to be effective in improving FM symptoms. An alternative to enhance CBT effectiveness is to incorporate digital therapeutics (DTx). Aim: We conducted a pilot study to investigate whether the addition of a DTx intervention (VirtualPain) to cognitive-behavioral group therapy (CBGT) can reduce pain perception and associated symptoms in patients with FM. Method: Ten patients with FM were initially recruited from a public hospital in Barcelona. The treatment consisted of 6 weeks of VirtualPain group sessions and 16 weeks of CBGT. Measures of catastrophizing, self-efficacy, and coping were recorded before, during, and after the protocol. In the DTx sessions, pain intensity was recorded before and after each session. Results: The program (DTx and CBGT) showed a significant improvement in pain-related self-efficacy and relaxation measures. Improvement in pain perception was observed only after the DTx intervention. Conclusions: This study provides preliminary results regarding the added value of DTx (VirtualPain) as part of a CBGT for FM. The use of the program has facilitated a significant reduction in pain perception in each of the VirtualPain sessions, which provides further evidence of how this technology can be beneficial for improving FM treatments.

10.
Biom J ; 66(1): e2200307, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37768850

ABSTRACT

In an individually randomized group treatment (IRGT) trial, participant outcomes can be positively correlated due to, for example, shared therapists in treatment delivery. Oftentimes, because of limited treatment resources or participants at one location, an IRGT trial can be carried out across multiple centers. This design can be subject to potential correlations in the participant outcomes between arms within the same center. While the design of a single-center IRGT trial has been studied, little is known about the planning of a multicenter IRGT trial. To address this gap, this paper provides analytical sample size formulas for designing multicenter IRGT trials with a continuous endpoint under the linear mixed model framework. We found that accounting for the additional center-level correlation at the design stage can lead to sample size reduction, and the magnitude of reduction depends on the amount of between-therapist correlation. However, if the variance components of therapist-level random effects are considered as input parameters in the design stage, accounting for the additional center-level variance component has no impact on the sample size estimation. We presented our findings through numeric illustrations and performed simulation studies to validate our sample size procedures under different scenarios. Optimal design configurations under the multicenter IRGT trials have also been discussed, and two real-world trial examples are drawn to illustrate the use of our method.


Subject(s)
Research Design , Humans , Cluster Analysis , Computer Simulation , Linear Models , Sample Size
11.
Drug Alcohol Rev ; 43(1): 245-256, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37574846

ABSTRACT

INTRODUCTION: Prison-based drug and alcohol group treatment programs operate in all Australian jurisdictions. With more than two-thirds of people in prison having a history of substance use prior to incarceration, such programs are needed. There have been few published papers on the impact of attending group treatment programs in Australian prisons, and the research published to date has been predominately quantitative. We aim to report the experiences of males in prison who completed and those who did not complete a group-based drug and alcohol program, to gain insight into their strategies for reducing harm from drug and alcohol post-release. METHODS: Qualitative thematic analysis of in-depth interviews with 12 males who completed or were about to complete and 10 males who discontinued a prison-based group drug and alcohol treatment program. RESULTS: Program completers were more likely to have well-developed plans to reduce drug and alcohol harms and maintain abstinence upon return to the community, which included creating healthier social networks. They also showed stronger insights into the factors that led to offending. Those who did not complete the drug and alcohol program appeared to rely on self-will as the main way to reduce drug and alcohol harms, with less awareness of options for support services to reduce or stop drug and alcohol use. DISCUSSION AND CONCLUSIONS: Prison-based drug and alcohol program engagement imparted useful information for program completers. Controlled trials are needed to examine whether such differences equate to improved outcomes after release.


Subject(s)
Prisoners , Substance-Related Disorders , Male , Humans , Prisons , Australia , Substance-Related Disorders/therapy
12.
J Clin Psychol ; 80(4): 884-899, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37921033

ABSTRACT

OBJECTIVES: In Metacognitive therapy (MCT), homework is used, for example, to increase awareness of thoughts and thought processes, to challenge metacognitive beliefs in real-life situations, and to practice new ways of processing thoughts, feelings, and symptoms. All MCT treatment manuals include homework assignments to be given between each session. METHOD: The following study provides a detailed description of the implementation of homework in a group-based MCT treatment for generalized anxiety disorder (GAD) at an outpatient clinic in Norway. The treatment described in this case consisted of 10 weekly group sessions (7 patients) lasting two hours. RESULTS: This case study demonstrates that group-based MCT can be used to treat GAD and describes how the use of homework can facilitate therapeutic change. CONCLUSION: Overall, the effectiveness of MCT was found to be high. Homework gives patients the opportunity to take charge of their therapy and develop a sense of responsibility for their own progress, both during and after treatment.


Subject(s)
Cognitive Behavioral Therapy , Metacognition , Psychotherapy, Group , Humans , Anxiety Disorders/psychology , Emotions
13.
Stat Med ; 43(2): 358-378, 2024 01 30.
Article in English | MEDLINE | ID: mdl-38009329

ABSTRACT

Individually randomized group treatment (IRGT) trials, in which the clustering of outcome is induced by group-based treatment delivery, are increasingly popular in public health research. IRGT trials frequently incorporate longitudinal measurements, of which the proper sample size calculations should account for correlation structures reflecting both the treatment-induced clustering and repeated outcome measurements. Given the relatively sparse literature on designing longitudinal IRGT trials, we propose sample size procedures for continuous and binary outcomes based on the generalized estimating equations approach, employing the block exchangeable correlation structures with different correlation parameters for the treatment arm and for the control arm, and surveying five marginal mean models with different assumptions of time effect: no-time constant treatment effect, linear-time constant treatment effect, categorical-time constant treatment effect, linear time by treatment interaction, and categorical time by treatment interaction. Closed-form sample size formulas are derived for continuous outcomes, which depends on the eigenvalues of the correlation matrices; detailed numerical sample size procedures are proposed for binary outcomes. Through simulations, we demonstrate that the empirical power agrees well with the predicted power, for as few as eight groups formed in the treatment arm, when data are analyzed using the matrix-adjusted estimating equations for the correlation parameters with a bias-corrected sandwich variance estimator.


Subject(s)
Models, Statistical , Research Design , Humans , Sample Size , Bias , Cluster Analysis , Computer Simulation
14.
Subst Abuse ; 17: 11782218231205840, 2023.
Article in English | MEDLINE | ID: mdl-37904747

ABSTRACT

Background: The purpose of this paper is to provide a preliminary evaluation of treatment outcomes, retention and client satisfaction following a 12-week combined cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) group treatment for cannabis use disorder (CUD) delivered in an outpatient setting. Implementation of the program is also described. Methods: A retrospective observational cohort study was conducted using data collected from medical records and self-report assessments. Participants were treatment-seeking cannabis users at the Centre for Addiction and Mental Health, Toronto. Cannabis use, cannabis-related problems, craving, withdrawal symptoms, self-efficacy for remaining abstinent, depression and anxiety were assessed pre- and post-treatment. Treatment retention was calculated by inspecting clinic attendance records, and client satisfaction was evaluated using an anonymous feedback survey. Potential predictors of treatment outcomes and retention were investigated in exploratory analyses. Results: Cannabis use was lower and days of abstinence higher post-treatment (vs pre-treatment). Post-treatment improvements in cannabis-related problems, craving, withdrawal symptoms, self-efficacy and mood were also observed. Completion of group treatment (⩾75% of sessions attended) was 57% and moderate levels of treatment satisfaction were reported. Conclusions: This study provides preliminary evidence that a 12-week combined CBT and MET treatment for cannabis use disorder delivered in a novel group setting improves cannabis use outcomes. Potential predictors of reduced cannabis use and retention were identified. Future controlled studies are warranted, and strategies for increasing retention should be explored.

15.
J Commun Disord ; 106: 106379, 2023.
Article in English | MEDLINE | ID: mdl-37769381

ABSTRACT

INTRODUCTION: There is limited research in group communication treatment for people with aphasia but existing studies report benefits of gesture to support conversation. Gesture supports conversation through recipient design features and reducing linguistic demands of lexical retrieval and formulation. Additionally, gesture serves an affiliative function. However, the relationship between gesture use and gestural capacity has not been widely examined. As part of a larger study on group cohesiveness and conversation, this investigation examined the patterns of co-speech gesture within authentic conversations among persons with aphasia to discern the functions of gesture use for the participants, changes in the use of gesture over time, and the relationship between gesture use and gesture ability. METHODS: Conversation Analysis (CA) was applied in an embedded case-study design. Three participants received an academic semester of group and individual conversation-based treatment according to Facilitating Authentic Conversation (Damico et al., 2015). Four conversations from the treatment were selected and transcribed for multi-modality communication with CA conventions applied, and then cyclically analysed for patterns of gesture. RESULTS: Participants demonstrated gesture that served social and linguistic functions: ratifying clinicians' proxy turns, turn-allocation, turn repair, relaying novel visual information, emphasizing content, demonstrating affiliation with the prior speaker, demonstrating their assessment others' talk, and demonstrating humor. All three participants showed an increased rate of gesture per turn and increasingly used gesture to repair conversation breakdown. Increased gesture use over the course of the semester coincided with increased scores for pantomime on the Porch Index of Communicative Ability (Porch, 1981, PICA). CONCLUSION: Individuals with aphasia demonstrated increased use of gesture for varied purposes and improved gestural processing following a semester of conversation-based treatment. This is significant because gesture is an effective support for the repair of conversation breakdown typical of persons with aphasia.


Subject(s)
Aphasia , Gestures , Humans , Communication , Aphasia/therapy , Linguistics
16.
J Commun Disord ; 105: 106363, 2023.
Article in English | MEDLINE | ID: mdl-37517172

ABSTRACT

BACKGROUND: Aphasia book clubs were developed to support connecting with literature and reading for pleasure within an aphasia-friendly environment. Bibliotherapy is an evidence-based therapeutic approach, in which a book is selected to address the challenges facing the reader. Its aim is to facilitate a deeper understanding of a lived experience in order to promote healing, strategy development, and adjustment. Aphasia book clubs provide an opportunity to discuss books about the challenges associated with aphasia. A recent book, Identity theft: Rediscovering ourselves after stroke recounts the stroke recovery story of Dr. Debra Meyerson and 22 other stroke survivors. Identity Theft focuses on the need to reconstruct positive identities despite remaining disabilities to facilitate rebuilding rewarding lives. The purpose of this study is to understand the impact of reading Identity Theft in an aphasia book club for people with aphasia (PwA). METHOD: 27 PwA read the book Identity Theft in one of four online aphasia book clubs offered by two universities. Weekly discussions were facilitated by graduate SLP students under the supervision of experienced clinicians. At the end of the 10 week program, semi-structured qualitative interviews were conducted with participants to understand the lived experience. Interviews were analyzed using reflexive thematic analysis. RESULTS: Analysis of the interview data generated four main themes and 13 subthemes. The main themes included: Mechanism for Reflection, Power of Community, Engaged Learning, and Therapeutic Environment. Interview extracts illustrate the way these themes support increasing self-efficacy and rebuilding a positive identity. CONCLUSION: The themes align positively with outcomes associated with the bibliotherapy process. Themes also integrate into a self-management model that promotes self-efficacy through education, support, awareness, problem solving and goal setting. Caveats included determining participant readiness to examine recovery issues and facilitator preparation. Aphasia book clubs surrounding psychosocial texts may help PwA reconstruct a positive post-stroke identity.


Subject(s)
Aphasia , Bibliotherapy , Stroke , Humans , Aphasia/psychology , Stroke/complications , Reading , Students
17.
Stat Med ; 42(19): 3392-3412, 2023 08 30.
Article in English | MEDLINE | ID: mdl-37316956

ABSTRACT

An important consideration in the design and analysis of randomized trials is the need to account for outcome observations being positively correlated within groups or clusters. Two notable types of designs with this consideration are individually randomized group treatment trials and cluster randomized trials. While sample size methods for testing the average treatment effect are available for both types of designs, methods for detecting treatment effect modification are relatively limited. In this article, we present new sample size formulas for testing treatment effect modification based on either a univariate or multivariate effect modifier in both individually randomized group treatment and cluster randomized trials with a continuous outcome but any types of effect modifier, while accounting for differences across study arms in the outcome variance, outcome intracluster correlation coefficient (ICC) and the cluster size. We consider cases where the effect modifier can be measured at either the individual level or cluster level, and with a univariate effect modifier, our closed-form sample size expressions provide insights into the optimal allocation of groups or clusters to maximize design efficiency. Overall, our results show that the required sample size for testing treatment effect heterogeneity with an individual-level effect modifier can be affected by unequal ICCs and variances between arms, and accounting for such between-arm heterogeneity can lead to more accurate sample size determination. We use simulations to validate our sample size formulas and illustrate their application in the context of two real trials: an individually randomized group treatment trial (the AWARE study) and a cluster randomized trial (the K-DPP study).


Subject(s)
Research Design , Humans , Sample Size , Cluster Analysis , Randomized Controlled Trials as Topic
18.
J Cogn Psychother ; 2023 Jun 27.
Article in English | MEDLINE | ID: mdl-37369540

ABSTRACT

The application of cognitive behavioral therapy (CBT) for hoarding disorder (HD) is described. We describe the components of CBT for HD and provide examples of how this treatment was implemented with two individuals at our clinic, one in group treatment and the other in individual therapy. These case examples are used to highlight a process of troubleshooting common barriers to treatment, enhancing motivation, creating structure, and assessing treatment progress. We compare the group and individual treatment for HD and discuss the pros and cons of each approach. Furthermore, we emphasize the importance of in-session practice, accountability and clear expectations, and realistic goal-setting across individual and group treatment. Finally, based on the cases included here, we highlight the need for additional research to extend CBT for HD (e.g., additional modules to help family members support a loved one in treatment for HD).

19.
Front Psychol ; 14: 1120203, 2023.
Article in English | MEDLINE | ID: mdl-37228335

ABSTRACT

Background: During the COVID-19 pandemic, psychological support was provided to healthcare workers in Nephrology and Dialysis Operative Unit of the Azienda Ospedaliera Bassini using an EMDR group protocol to decrease posttraumatic stress symptoms in the medium and long term. The aim of this study was to demonstrate the effectiveness of EMDR treatment to reduce post-traumatic stress symptoms at the end of the first pandemic wave and its progress over time in the subsequent phases of the health emergency. Methods: The sample of study consisted of 43 healthcare workers from the Nephrology and Dialysis Service who spontaneously decided to take part in the Brief EMDR treatment. Statistical analyses were carried out to compare the data collected with the IES-R, the Emotion Thermometer and the Post-Traumatic Growth Scale. The comparisons covered pre-treatment, post-treatment and follow-up. Results: The results show a significant clinical improvement in reducing PTSD symptoms following the Brief EMDR group treatment. The comparison between PRE and POST treatment (DELTA1) regarding the scores from IES-R and Emotion Thermometer, highlighted the important statistically change that occurred in terms of symptomatology reduction (p < 0.001). By comparing POST and FU (DELTA2), it was observed that all variables except avoidance show a significant weakening of the effect with time (p < 0.001), but the magnitude of this effect is much smaller than the improvement found in DELTA1. DELTA 3 analysis finally made it possible to highlight how the treatment effect is maintained almost intact at follow-up. In fact, the maintenance of a better situation at follow-up was observed, in the course of re-traumatization linked to the new wave, compared to the initial data (p < 0.001). Conclusion: The COVID-19 health emergency has significantly impacted hospital healthcare workers, leading to a high risk of developing PTSD symptoms. A psychological intervention aimed at the operators themselves is therefore of great importance.

20.
Front Psychol ; 14: 1129912, 2023.
Article in English | MEDLINE | ID: mdl-37063579

ABSTRACT

Objective: Frontline mental health, emergency, law enforcement, and social workers have faced unprecedented psychological distress in responding to the COVID-19 pandemic. The purpose of the RCT (Randomized Controls Trial) study was to investigate the effectiveness of a Group EMDR (Eye Movement Desensitization and Reprocessing) therapy (Group Traumatic Episode Protocol-GTEP) in the treatment of Post-Traumatic Stress Disorder (PTSD) and Moral Injury. The treatment focus is an early intervention, group trauma treatment, delivered remotely as video-conference psychotherapy (VCP). This early intervention used an intensive treatment delivery of 4x2h sessions over 1-week. Additionally, the group EMDR intervention utilized therapist rotation in treatment delivery. Methods: The study's design comprised a delayed (1-month) treatment intervention (control) versus an active group. Measurements included the International Trauma Questionnaire (ITQ), Generalized Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Moral Injury Events Scale (MIES), and a Quality-of-Life psychometric (EQ-5D), tested at T0, T1: pre-treatment, T2: post-treatment, T3: 1-month follow-up (FU), T4: 3-month FU, and T5: 6-month FU. The Adverse Childhood Experiences - International version (ACEs), Benevolent Childhood Experience (BCEs) was ascertained at pre-treatment only. N = 85 completed the study. Results: Results highlight a significant treatment effect within both active and control groups. Post Hoc comparisons of the ITQ demonstrated a significant difference between T1 pre (mean 36.8, SD 14.8) and T2 post (21.2, 15.1) (t11.58) = 15.68, p < 0.001). Further changes were also seen related to co-morbid factors. Post Hoc comparisons of the GAD-7 demonstrated significant difference between T1 pre (11.2, 4.91) and T2 post (6.49, 4.73) (t = 6.22) = 4.41, p < 0.001; with significant difference also with the PHQ-9 between T1 pre (11.7, 5.68) and T2 post (6.64, 5.79) (t = 6.30) = 3.95, p < 0.001, d = 0.71. The treatment effect occurred irrespective of either ACEs/BCEs during childhood. However, regarding Moral Injury, the MIES demonstrated no treatment effect between T1 pre and T5 6-month FU. The study's findings discuss the impact of Group EMDR therapy delivered remotely as video-conference psychotherapy (VCP) and the benefits of including a therapist/rotation model as a means of treatment delivery. However, despite promising results suggesting a large treatment effect in the treatment of trauma and adverse memories, including co-morbid symptoms, research results yielded no treatment effect in frontline/emergency workers in addressing moral injury related to the COVID-19 pandemic. Conclusion: The NICE (2018) guidance on PTSD highlighted the paucity of EMDR therapy research used as an early intervention. The primary rationale for this study was to address this critical issue. In summary, treatment results for group EMDR, delivered virtually, intensively, using therapist rotation are tentatively promising, however, the moral dimensions of trauma need consideration for future research, intervention development, and potential for further scalability. The data contributes to the emerging literature on early trauma interventions.Clinical Trial Registration:Clinicaltrials.gov, ISRCTN16933691.

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