Eating Disorders With and Without Childhood Trauma

Not Applicable

Completed

• Conditions: Eating Disorders; Stress Disorders, Post-traumatic
• Interventions: Behavioral: Compassion-Focused Therapy; Behavioral: Cognitive-Behavioural Therapy

• Registration Number: NCT02649114
• Lead Sponsor: Modum Bad

Brief Summary

The combination of EDs (ED) and post-traumatic sequelae of childhood trauma leads to significant impairment, suffering and represents a public health concern because it is frequently associated with role impairment, and is frequently under-treated. Considering the severity of these conditions, there is a need to develop more effective treatments that are tailored to the specific needs of these patients as no conclusion has been made about the treatment of choice. To improve treatment it is critically important to study treatment effects and the mechanism of these effects.

Detailed Description

The overall aim of the current project is; (1) To build knowledge on how to best treat patients with ED with and without childhood trauma, (2) To develop our understanding about how change happens for these patients. The investigators will do this by compare two treatment models; (1) Compassion-Focused Therapy (CFT) and (2) Cognitive Behavioural Therapy (CBT), for EDs both treatment types delivered at Modum Bad Psychiatric Center, department of ED.

Patients included in this randomized controlled trial will receive treatment at Modum Bad, satisfy DSM-V criteria for ED and half of the patients will in addition have a history of childhood trauma. A total of 86 patients who have received either CFT or CBT are followed up two year after completion of the treatment. The study utilises a rich data set collected outcome measures at altogether 5 time points and process and sub-outcome measures at 13 time points. The investigators will take advantage of our established collaborative networks, both nationally and internationally and existing procedures, where all patients are assessed with the same clinical instruments based on current state-of-the-art methods.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• satisfying DSM-V criteria for ED and for half of the patients in addition
• have a history of childhood trauma.

Exclusion Criteria

• current suicidal risk
• current psychosis
• ongoing trauma (e.g. current involvement in an abusive relationship).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compassion-Focused Therapy	Compassion-Focused Therapy	There are four main treatment elements to the program. Two of these are linked to the experience of being a therapy group. This involves patients providing compassionate support to other group members.The third treatment element involves compassionate mind training which mainly focuses on activating the soothing system via imagery and related practical exercises.The final element of the program aims to help patients improve their ability to use their wider social network to access support.
Cognitive-Behavioural Therapy	Cognitive-Behavioural Therapy	This version of CBT is based on techniques employed in evidence-based approaches to a transdiagnostic sample. The programme includes; individualized formulation, taking into account different maintaining factors across cases (e.g., nutritional and/or emotional drivers for binging); agenda setting; homework; change in diet (particularly to improve carbohydrate intake); diary-keeping; exposure; behavioral experiments; cognitive restructuring; and surveys. The behavioral change is maintained as a focus, along with changes in mood and cognitions.

Primary Outcome Measures

Name	Time	Method
Global index from Eating Disorder Examination questionnaire	Pre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 year	Change from baseline in eating disorder symptoms on the dimensional scales on the Eating Disorder Examination questionnaire

Secondary Outcome Measures

Name	Time	Method
Short form 36	Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year	Change from baseline to 12-months follow-up
Symptom checklist 90 revised	Time Frame: pre, post and 12-months followup, through study completion, an average of 1 year	Change from baseline to 12-months follow-up
Inventory of interpersonal problems	Pre, post and 12-months followup, through study completion, an average of 1 year	Change from baseline to 12-months follow-up
Dissociative experiences scale II	Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year	Change from baseline to 12-months follow-up
Self-compassion scale	Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year	Change from baseline to 12-months follow-up
Symptom checklist-5	Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 year	Change from baseline to 12-months follow-up

Trial Locations

Locations (1)

Modum Bad; 🇳🇴 Vikersund, Norway