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Eating DisordersNCT02649114

Eating Disorders With and Without Childhood Trauma

A study testing Cognitive-Behavioural Therapy and Compassion-Focused Therapy in people with Eating Disorders and Stress Disorders, Post-traumatic, run by Modum Bad at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive-Behavioural Therapy and Compassion-Focused Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteNorway
Study dates
Aug 2015to Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Modum Bad

    Vikersund, 3371

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
Cognitive-Behavioural Therapy, Compassion-Focused Therapy
Medical subject headings
Feeding and Eating Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Behavioural TherapyBehavioural

  • Compassion-Focused TherapyBehavioural

Study groups in NCT02649114
Study groupRoleWhat they receive
Cognitive-Behavioural TherapyActive comparatorThis 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.
Receives: Behavioral: Cognitive-Behavioural Therapy
Compassion-Focused TherapyExperimentalThere 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.
Receives: Behavioral: Compassion-Focused Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Pre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 year

Secondary outcomes (6)

  1. Symptom checklist 90 revised

    Change from baseline to 12-months follow-up

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

  2. Inventory of interpersonal problems

    Change from baseline to 12-months follow-up

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

  3. Dissociative experiences scale II

    Change from baseline to 12-months follow-up

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

  4. Short form 36

    Change from baseline to 12-months follow-up

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

  5. Self-compassion scale

    Change from baseline to 12-months follow-up

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

  6. Symptom checklist-5

    Change from baseline to 12-months follow-up

    Measured: Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649114
Sponsor's protocol ID
2014/836-1
Status last verified
Feb 2020
First submitted
8 Sep 2015
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Olofsson ME, Giltay EJ, Eielsen HP, Vrabel K, Oddli HW, Kopland MC. From promise to practice: showcasing the perceived clinical utility of idiographic networks for eating disorders with complex post-traumatic sequelae. J Eat Disord. 2026 Mar 25;14(1):101. doi: 10.1186/s40337-026-01579-w.

    PubMed 41882806

  • 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.

    PubMed 40267178

  • Vrabel KR, Bratland-Sanda S. Effects of inpatient treatment on compulsive exercise in adults with longstanding eating disorders: Secondary analysis from a randomized controlled trial with 12-month follow-up. Int J Eat Disord. 2024 Feb;57(2):437-449. doi: 10.1002/eat.24108. Epub 2023 Dec 29.

    PubMed 38158782

  • Kopland MCG, Vrabel K, Slof-Op 't Landt M, Hoffart A, Johnson SU, Giltay EJ. Breaking the cycle: Identifying key symptom pathways of eating disorders and the influence of childhood maltreatment. Int J Eat Disord. 2024 Feb;57(2):316-326. doi: 10.1002/eat.24097. Epub 2023 Nov 25.

    PubMed 38006259

  • 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.

    PubMed 36630619

  • 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.

    PubMed 31379673

  • 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.

    PubMed 31368720

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioural Therapy and Compassion-Focused Therapy in people with Eating Disorders and Stress Disorders, Post-traumatic, run by Modum Bad at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global index from Eating Disorder Examination questionnaire (time frame: Pre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02649114, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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