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Eating Disorders With and Without Childhood Trauma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02649114
Enrollment
130
Registered
2016-01-07
Start date
2015-08-31
Completion date
2020-02-29
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders, Stress Disorders, Post-traumatic

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.

Interventions

Sponsors

Modum Bad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Global index from Eating Disorder Examination questionnairePre, weekly during treatment, post, 12-months followup, through study completion, an average of 1 yearChange from baseline in eating disorder symptoms on the dimensional scales on the Eating Disorder Examination questionnaire

Secondary

MeasureTime frameDescription
Inventory of interpersonal problemsPre, post and 12-months followup, through study completion, an average of 1 yearChange from baseline to 12-months follow-up
Dissociative experiences scale IIPretreatment, posttreatment and 12-months followup, through study completion, an average of 1 yearChange from baseline to 12-months follow-up
Symptom checklist 90 revisedTime Frame: pre, post and 12-months followup, through study completion, an average of 1 yearChange from baseline to 12-months follow-up
Self-compassion scalePretreatment, posttreatment and 12-months followup, through study completion, an average of 1 yearChange from baseline to 12-months follow-up
Symptom checklist-5Pretreatment, weekly during treatment, posttreatment and 12-months followupthrough study completion, an average of 1 yearChange from baseline to 12-months follow-up
Short form 36Pretreatment, posttreatment and 12-months followup, through study completion, an average of 1 yearChange from baseline to 12-months follow-up

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026