Eating Disorders With and Without Childhood Trauma

Stress Disorders, Post-traumatic Clinical Trial

Official title:

Treatment of Eating Disorders With and Without Childhood Trauma: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649114
• Other study ID #: 2014/836-1
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Modum Bad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Cognitive-Behavioural Therapy

• Compassion-Focused Therapy

Locations

Country	Name	City	State
Norway	Modum Bad	Vikersund

Sponsors (1)

Lead Sponsor	Collaborator
Modum Bad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global index from Eating Disorder Examination questionnaire	Change from baseline in eating disorder symptoms on the dimensional scales on the Eating Disorder Examination questionnaire	Pre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 year
Secondary	Symptom checklist 90 revised	Change from baseline to 12-months follow-up	Time Frame: pre, post and 12-months followup, through study completion, an average of 1 year
Secondary	Inventory of interpersonal problems	Change from baseline to 12-months follow-up	Pre, post and 12-months followup, through study completion, an average of 1 year
Secondary	Dissociative experiences scale II	Change from baseline to 12-months follow-up	Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
Secondary	Short form 36	Change from baseline to 12-months follow-up	Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
Secondary	Self-compassion scale	Change from baseline to 12-months follow-up	Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 year
Secondary	Symptom checklist-5	Change from baseline to 12-months follow-up	Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 year