Eating Disorders With and Without Childhood Trauma

Treatment of Eating Disorders With and Without Childhood Trauma: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Eating Disorders; Stress Disorders, Post-traumatic
• Intervention / Treatment: Behavioral: Cognitive-Behavioural Therapy; Behavioral: Compassion-Focused Therapy

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Vikersund, Norway, 3371
    • Modum Bad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Cognitive-Behavioural Therapy
Experimental: 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.	Behavioral: Compassion-Focused Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Modum Bad
• Investigators: Principal Investigator: KariAnne Vrabel, PhD, Modum Bad

Publications and helpful links

General Publications

• Vrabel KR, Wampold B, Quintana DS, Goss K, Waller G, Hoffart A. 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. Front Psychol. 2019 Jul 18;10:1638. doi: 10.3389/fpsyg.2019.01638. eCollection 2019.
• Olofsson ME, Oddli HW, Hoffart A, Eielsen HP, Vrabel KR. Change processes related to long-term outcomes in eating disorders with childhood trauma: An explorative qualitative study. J Couns Psychol. 2020 Jan;67(1):51-65. doi: 10.1037/cou0000375. Epub 2019 Aug 1.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Disease; Stress Disorders, Post-Traumatic; Feeding and Eating Disorders
• Other Study ID Numbers: 2014/836-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO