Dataset Information

The Modum-ED Trial Protocol: Comparing Compassion-Focused Therapy and Cognitive-Behavioral Therapy in Treatment of Eating Disorders With and Without Childhood Trauma: Protocol of a Randomized Trial.

ABSTRACT: Background: The combination of eating disorder (ED) and the experience of childhood trauma leads to significant impairment and suffering. To improve treatment, it is critically important to study treatment effects, and the mechanism of these effects. The overall aim of the current project is to; (1) build knowledge on how to best treat patients with ED with and without childhood trauma, (2) develop our understanding about how change happens for these patients. We will do this by comparing two treatment models in an inpatient setting; Compassion-Focused Therapy (CFT) and cognitive-behavioral therapy (CBT) for ED. This paper describes the development, design and implementation of the trial. Methods and Design: Patients included in this randomized controlled trial will satisfy DSM-5 criteria for ED and approximately half of the patients will in addition have a history of childhood trauma. A total of 144 patients who have received either CFT or CBT are followed up 1 year after completion of the treatment. The study will collect a rich dataset of outcome measures at four time points, and process and sub-outcome measures at 13 time points. All patients will be assessed with the same clinical instruments based on current state-of-the-art methods. The primary outcome will be change in the severity of ED features as measured by the global ED examination score, and having a global ED examination score less than one standard deviation above the community mean, while secondary outcomes will relate to treatment effects on trauma symptoms, general symptoms, and quality of life. Discussion: This trial will make an important contribution to the need for evidence of effective treatment for patients with ED with or without childhood trauma. Ethics and Dissemination: The project is approved by the South-Eastern Regional Committee for Medical and Health Research Ethics of Norway (REC;2014/836). Clinical Trial Registration: ClinicalTrials.gov, http://www.Clinicaltrials.gov/ct2/show/NCT02649114.

SUBMITTER: Vrabel KR

PROVIDER: S-EPMC6657670 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The Modum-ED Trial Protocol: Comparing Compassion-Focused Therapy and Cognitive-Behavioral Therapy in Treatment of Eating Disorders With and Without Childhood Trauma: Protocol of a Randomized Trial.

Vrabel KariAnne R KR Wampold Bruce B Quintana Daniel S DS Goss Ken K Waller Glenn G Hoffart Asle A

Frontiers in psychology 20190718

<b>Background:</b> The combination of eating disorder (ED) and the experience of childhood trauma leads to significant impairment and suffering. To improve treatment, it is critically important to study treatment effects, and the mechanism of these effects. The overall aim of the current project is to; (1) build knowledge on how to best treat patients with ED with and without childhood trauma, (2) develop our understanding about how change happens for these patients. We will do this by comparing ...[more]

PMID: 31379673

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Project description:ImportanceOrphans and vulnerable children (OVC) are at high risk for experiencing trauma and related psychosocial problems. Despite this, no randomized clinical trials have studied evidence-based treatments for OVC in low-resource settings.ObjectiveTo evaluate the effectiveness of lay counselor-provided trauma-focused cognitive behavioral therapy (TF-CBT) to address trauma and stress-related symptoms among OVC in Lusaka, Zambia.Design, setting, and participantsThis randomized clinical trial compared TF-CBT and treatment as usual (TAU) (varying by site) for children recruited from August 1, 2012, through July 31, 2013, and treated until December 31, 2013, for trauma-related symptoms from 5 community sites within Lusaka, Zambia. Children were aged 5 through 18 years and had experienced at least one traumatic event and reported significant trauma-related symptoms. Analysis was with intent to treat.InterventionsThe intervention group received 10 to 16 sessions of TF-CBT (n = 131). The TAU group (n = 126) received usual community services offered to OVC.Main outcomes and measuresThe primary outcome was mean item change in trauma and stress-related symptoms using a locally validated version of the UCLA Posttraumatic Stress Disorder Reaction Index (range, 0-4) and functional impairment using a locally developed measure (range, 0-4). Outcomes were measured at baseline and within 1 month after treatment completion or after a waiting period of approximately 4.5 months after baseline for TAU.ResultsAt follow-up, the mean item change in trauma symptom score was -1.54 (95% CI, -1.81 to -1.27), a reduction of 81.9%, for the TF-CBT group and -0.37 (95% CI, -0.57 to -0.17), a reduction of 21.1%, for the TAU group. The mean item change for functioning was -0.76 (95% CI, -0.98 to -0.54), a reduction of 89.4%, and -0.54 (95% CI, -0.80 to -0.29), a reduction of 68.3%, for the TF-CBT and TAU groups, respectively. The difference in change between groups was statistically significant for both outcomes (P < .001). The effect size (Cohen d) was 2.39 for trauma symptoms and 0.34 for functioning. Lay counselors participated in supervision and assessed whether the intervention was provided with fidelity in all 5 community settings.Conclusions and relevanceThe TF-CBT adapted for Zambia substantially decreased trauma and stress-related symptoms and produced a smaller improvement in functional impairment among OVC having experienced high levels of trauma.Trial registrationclinicaltrials.gov Identifier: NCT01624298.

Project description:BackgroundMore than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services-schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes.MethodsUsing a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4-6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness.DiscussionThis study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS-a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation-to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting.Trial registrationClinicalTrials.gov registration number NCT04451161 . Registered on June 30, 2020.

Project description:BackgroundThe effectiveness of mental health interventions such as trauma-focused cognitive behavioral therapy (TF-CBT) may vary by client, caregiver, and intervention-level variables, but few randomized trials in low- and middle-income countries (LMIC) have conducted moderation analyses to investigate these characteristics. This study explores moderating factors to TF-CBT treatment response among a sample of orphans and vulnerable children (OVC) in Zambia.MethodsData were obtained from a completed randomized trial of TF-CBT among 257 OVC in Zambia. Trauma symptoms and functioning were measured at baseline and following the end of treatment. Mixed effects regression models were estimated for each moderator of interest: gender, age, number of trauma types experienced, history of sexual abuse, orphan status, primary caretaker, school status, and parental involvement in treatment.ResultsTreatment effectiveness was moderated by history of sexual abuse with greater reductions in both outcomes (trauma, p < .05; functioning, p < .01) for those that experienced sexual abuse. Primary caretaker was also a moderator with greater trauma reductions in those who identified their mother as the primary caretaker (p < .01), and better functioning in those that identified their father as the primary caretaker (p < .05). Nonorphans and single orphans (mother alive) showed greater reduction in functional impairment (p < .01) compared with double orphans. There was no significant moderator effect found by gender, age, number of trauma types, school status, or caregiver participation in treatment.ConclusionsThis study suggests that TF-CBT was effective in reducing trauma symptoms and functional impairment among trauma-affected youth overall and that it may be particularly effective for survivors of child sexual abuse and children whose primary caretaker is a biological parent. Scale-up of TF-CBT is warranted given the wide range of effectiveness and prevalence of child sexual abuse. Future randomized trials of interventions in LMIC should power for moderation analyses in the study design phase when feasible.

Dataset Information

The Modum-ED Trial Protocol: Comparing Compassion-Focused Therapy and Cognitive-Behavioral Therapy in Treatment of Eating Disorders With and Without Childhood Trauma: Protocol of a Randomized Trial.

Publications

The Modum-ED Trial Protocol: Comparing Compassion-Focused Therapy and Cognitive-Behavioral Therapy in Treatment of Eating Disorders With and Without Childhood Trauma: Protocol of a Randomized Trial.

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