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Eating Disorders With and Without Childhood Trauma

M

Modum Bad

Status

Completed

Conditions

Eating Disorders
Stress Disorders, Post-traumatic

Treatments

Behavioral: Compassion-Focused Therapy
Behavioral: Cognitive-Behavioural Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02649114
2014/836-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

130 participants in 2 patient groups

Cognitive-Behavioural Therapy
Active Comparator group
Description:
This version of CBT is based on techniques employed in evidence-based approaches to a transdiagnostic sample. The programme includes; individualized formulation, taking into account different maintaining factors across cases (e.g., nutritional and/or emotional drivers for binging); agenda setting; homework; change in diet (particularly to improve carbohydrate intake); diary-keeping; exposure; behavioral experiments; cognitive restructuring; and surveys. The behavioral change is maintained as a focus, along with changes in mood and cognitions.
Treatment:
Behavioral: Cognitive-Behavioural Therapy
Compassion-Focused Therapy
Experimental group
Description:
There are four main treatment elements to the program. Two of these are linked to the experience of being a therapy group. This involves patients providing compassionate support to other group members.The third treatment element involves compassionate mind training which mainly focuses on activating the soothing system via imagery and related practical exercises.The final element of the program aims to help patients improve their ability to use their wider social network to access support.
Treatment:
Behavioral: Compassion-Focused Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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