Eating Disorders With and Without Childhood Trauma

NCT02649114 | Completed

• 1 other identifier: 2014/836-1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Stress Disorders, Post-traumatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Symptom checklist 90 revised

  Time Frame: pre, post and 12-months followup, through study completion, an average of 1 year

• Inventory of interpersonal problems

  Pre, post and 12-months followup, through study completion, an average of 1 year

• Dissociative experiences scale II

  Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year

• Short form 36

  Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year

• Self-compassion scale

  Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year

Study Arms (2)

Cognitive-Behavioural Therapy

ACTIVE COMPARATOR

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

Compassion-Focused Therapy

EXPERIMENTAL

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

Interventions

Cognitive-Behavioural Therapy BEHAVIORAL

Cognitive-Behavioural Therapy

Compassion-Focused Therapy BEHAVIORAL

Compassion-Focused Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Modum Bad: lead

Study Sites (1)

Modum Bad

Vikersund, 3371, Norway

Location

Related Publications (4)

• Eielsen HP, Vrabel K, Olofsson ME. <<Scaringly Safe>>: Therapeutic Processes in Longstanding Eating Disorders With Comorbid Avoidant Personality Disorders in the Recovered Case of Jade. J Clin Psychol. 2025 Aug;81(8):694-705. doi: 10.1002/jclp.23805. Epub 2025 Apr 23.

  PMID: 40267178 DERIVED

• Kopland MCG, Vrabel K, Melsom L, Hoffart A, Johnson SU. Self-compassion in eating disorders and childhood trauma: A study of within-person effects in a randomized controlled trial. Psychother Res. 2023 Jun;33(5):640-653. doi: 10.1080/10503307.2022.2149363. Epub 2023 Jan 11.

  PMID: 36630619 DERIVED

• 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.

  PMID: 31379673 DERIVED

• 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.

  PMID: 31368720 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• KariAnne Vrabel, PhD

  Modum Bad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: January 7, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)