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Eating Disorders With and Without Childhood Trauma

Primary Purpose

Eating Disorders, Stress Disorders, Post-traumatic

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive-Behavioural Therapy
Compassion-Focused Therapy
Sponsored by
Modum Bad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Modum Bad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive-Behavioural Therapy

Compassion-Focused Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Global index from Eating Disorder Examination questionnaire
Change from baseline in eating disorder symptoms on the dimensional scales on the Eating Disorder Examination questionnaire

Secondary Outcome Measures

Symptom checklist 90 revised
Change from baseline to 12-months follow-up
Inventory of interpersonal problems
Change from baseline to 12-months follow-up
Dissociative experiences scale II
Change from baseline to 12-months follow-up
Short form 36
Change from baseline to 12-months follow-up
Self-compassion scale
Change from baseline to 12-months follow-up
Symptom checklist-5
Change from baseline to 12-months follow-up

Full Information

First Posted
September 8, 2015
Last Updated
February 21, 2020
Sponsor
Modum Bad
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1. Study Identification

Unique Protocol Identification Number
NCT02649114
Brief Title
Eating Disorders With and Without Childhood Trauma
Official Title
Treatment of Eating Disorders With and Without Childhood Trauma: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modum Bad

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Stress Disorders, Post-traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioural Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Compassion-Focused Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioural Therapy
Intervention Type
Behavioral
Intervention Name(s)
Compassion-Focused Therapy
Primary Outcome Measure Information:
Title
Global index from Eating Disorder Examination questionnaire
Description
Change from baseline in eating disorder symptoms on the dimensional scales on the Eating Disorder Examination questionnaire
Time Frame
Pre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Symptom checklist 90 revised
Description
Change from baseline to 12-months follow-up
Time Frame
Time Frame: pre, post and 12-months followup, through study completion, an average of 1 year
Title
Inventory of interpersonal problems
Description
Change from baseline to 12-months follow-up
Time Frame
Pre, post and 12-months followup, through study completion, an average of 1 year
Title
Dissociative experiences scale II
Description
Change from baseline to 12-months follow-up
Time Frame
Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
Title
Short form 36
Description
Change from baseline to 12-months follow-up
Time Frame
Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
Title
Self-compassion scale
Description
Change from baseline to 12-months follow-up
Time Frame
Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
Title
Symptom checklist-5
Description
Change from baseline to 12-months follow-up
Time Frame
Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KariAnne Vrabel, PhD
Organizational Affiliation
Modum Bad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Modum Bad
City
Vikersund
ZIP/Postal Code
3371
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31379673
Citation
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.
Results Reference
derived
PubMed Identifier
31368720
Citation
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.
Results Reference
derived

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Eating Disorders With and Without Childhood Trauma

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