Clinical trial NCT02649114: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Stress Disorders, Post-traumatic
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Global index from Eating Disorder Examination questionnaire
timeFrame: Pre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 year
Secondary outcomes:
measure: Symptom checklist 90 revised
timeFrame: Time Frame: pre, post and 12-months followup, through study completion, an average of 1 year
measure: Inventory of interpersonal problems
timeFrame: Pre, post and 12-months followup, through study completion, an average of 1 year
measure: Dissociative experiences scale II
timeFrame: Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
measure: Short form 36
timeFrame: Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
measure: Self-compassion scale
timeFrame: Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
measure: Symptom checklist-5
timeFrame: Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 year
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
Study officials:
affiliation: Modum Bad
name: KariAnne Vrabel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.