NCT02058121

Brief Summary

The purpose of this study was to test if an ACT group intervention focusing on body image reduces eating disorders symptoms and reduces care consumption in patients treated at a specialised eating disorder unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

4.4 years

First QC Date

February 6, 2014

Last Update Submit

January 11, 2019

Conditions

Eating Disorder

Keywords

Eating disordersAcceptance and Commitment TherapyBody image

Outcome Measures

Primary Outcomes (1)

  • Eating disorder symptoms

    Assessed through the Eating Disorder Examination-Questionnaire (EDE-Q). The EDE-Q consists of 28 questions assessing eating disordered symptoms for the past 28 Days. A global score is calculated based on 22 of the items, ranging from 0-6. The 22 items can be divided into four subscales, assessing eating restraint, eating concern, shape concern and weight concern, also in the range of 0-6. A higher score indicates more severe eating disordered symptoms.

    24 months follow up

Secondary Outcomes (4)

  • Changes in Mindful awareness

    24 month follow up

  • Measure of body shape preoccupations.

    24 months

  • Measurement of body checking

    24 months

  • Measure changes in self-concept

    24 months

Other Outcomes (2)

  • Differences in amount of healthcare received after treatment intervention

    24 months

  • The participants opinions regarding the intervention

    24 months

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL
Behavioral: Acceptance and Commitment Therapy

Treatment as usual

ACTIVE COMPARATOR
Behavioral: Treatment as usual

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

ACT is provided in 12 weekly two hour long sessions in a group setting

Acceptance and Commitment Therapy
Treatment as usualBEHAVIORAL

Treatment as usual contains different interventions available at the clinic, such as individual therapy, group therapy, or contact with a physician, dietician and/or physiotherapist.

Treatment as usual

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed with an eating disorder according to DSM-IV (APA, 1994)
  • Enrolled as a patient at Eriksbergsgarden, a clinic in Sweden offering specialized care for patients with an eating disorder
  • Attained a somewhat regular eating pattern consisting of at least three meals per day

You may not qualify if:

  • Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eriksbergsgarden, Orebro County Counsil

Örebro, Orebro County Counsil, 701 85, Sweden

Location

Related Publications (1)

  • Fogelkvist M, Parling T, Kjellin L, Gustafsson SA. A qualitative analysis of participants' reflections on body image during participation in a randomized controlled trial of acceptance and commitment therapy. J Eat Disord. 2016 Dec 12;4:29. doi: 10.1186/s40337-016-0120-4. eCollection 2016.

    PMID: 27999670DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Acceptance and Commitment TherapyTherapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sanna Gustafsson, PhD

    Psychiatric research centre, Orebro County Counsil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Med.dr

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 7, 2014

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

August 1, 2016

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

SE(1)