Eating Disorders With and Without Childhood Trauma

NCT ID: NCT02649114

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-02-29

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.

Conditions

Eating Disorders; Stress Disorders, Post-traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioural Therapy

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Compassion-Focused Therapy

Intervention Type: BEHAVIORAL

Interventions

Cognitive-Behavioural Therapy

Intervention Type: BEHAVIORAL

Compassion-Focused Therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Modum Bad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KariAnne Vrabel, PhD

Role: PRINCIPAL_INVESTIGATOR

Modum Bad

Locations

Modum Bad

Vikersund, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 40267178 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36630619 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31379673 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31368720 (View on PubMed)

Other Identifiers

2014/836-1

Identifier Type: -

Identifier Source: org_study_id