Treatment of Eating Disorders With and Without Childhood Trauma: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Eating Disorders
- Sponsor
- Modum Bad
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Global index from Eating Disorder Examination questionnaire
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
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
Change from baseline in eating disorder symptoms on the dimensional scales on the Eating Disorder Examination questionnaire
Secondary Outcomes
- Short form 36(Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year)
- 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)
- Self-compassion scale(Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year)
- Symptom checklist-5(Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 year)