Skip to main content
OpenTrials
Completed

NCT Number: NCT02649114

Eating Disorders With and Without Childhood Trauma

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Modum Bad

Vikersund, 3371, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive-Behavioural Therapy

Behavioral

Compassion-Focused Therapy

Behavioral

Primary outcomes

  1. 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

  1. Symptom checklist 90 revised

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

    Change from baseline to 12-months follow-up

  2. Inventory of interpersonal problems

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

    Change from baseline to 12-months follow-up

  3. Dissociative experiences scale II

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

    Change from baseline to 12-months follow-up

  4. Short form 36

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

    Change from baseline to 12-months follow-up

  5. Self-compassion scale

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

    Change from baseline to 12-months follow-up

  6. Symptom checklist-5

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

    Change from baseline to 12-months follow-up

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2016
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.