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An ACT Group Intervention for ED-patients

Primary Purpose

Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Treatment as usual
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring Eating disorders, Acceptance and Commitment Therapy, Body image

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Eriksbergsgarden, Orebro County Counsil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance and Commitment Therapy

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Mindful awareness
Assessed through the Mindful Attention Awareness Scale (MAAS). The MAAS consists of 15 questions, ranging from 1 to 6. A global score is calculated where higher scoring indicates more mindful awareness.
Measure of body shape preoccupations.
Assessed through the Body Shape Questionnaire (BSQ), a short Swedish version consisting of 8 questions. A total score is calculated, ranging from 8 to 48, where higher scoring indicates more severe concerns.
Measurement of body checking
Assessed through the Body Checking Questionnaire (BCQ). The BCQ consist of 23 questions ranging from 1 to 5. A global score is calculated ranging from 23 to 115, where a higher scoring indicates more frequent use of behaviours related to a negative body image.
Measure changes in self-concept
Assessed through the Self-Concept Questionnaire (SCQ). The SCQ consists of 30 questions ranging from 0 to 7. A global score is calculated where higher scorings indicates a higher self-esteem.

Full Information

First Posted
February 6, 2014
Last Updated
January 11, 2019
Sponsor
Örebro County Council
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT02058121
Brief Title
An ACT Group Intervention for ED-patients
Official Title
Randomised Controlled Trial With Acceptance and Commitment Therapy (ACT) for Patients With Eating Disorders - a Manualised Group Therapy to Enhance Body Acceptance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study is an RCT in which the ACT-intervention is compared to treatment as usual. The trial started in 2010, and randomisation of patients continued until 2014, and follow-ups was completed in 2016. According to analysis of power, a total of 120 patients needed to be included, 60 in each arm. Patients eligible for the interventions were invited to participate after their clinician reported them to the head investigator. The head investigator sent a letter to the patients with information on the study. The clinician then asked the patient if the letter had been read. If the patient wanted to participate, he/she was invited to an information and assessment meeting. The head investigator made sure that the patient understood the information, and what each study arm might mean for the patient when participating. Consent to participate was collected both verbally and in writing. At this meeting the patient received an envelope which contained the randomisation outcome. The patient then received information regarding the continued treatment according to which research arm he/she was to participate in. The participants randomised to treatment as usual continued with the treatment as planned before enrolment. Participants in the intervention arm started the group intervention consisting of 12 sessions over a period of three to four months. The intervention also included one individual meeting with the group-leaders before and one after the intervention. The intervention is a manualised application of the book "Lev med din kropp" [Live with your body]. Participants who were in need of further care after the intervention were offered continued treatment accordingly at the clinic. If a participant chose to terminate the intervention, or deteriorated during the intervention to the point that other treatment was needed, further treatment was agreed upon in dialogue with the patient. If needed, further assessment and physical examination was conducted in accordance to the clinics standard procedures. Data was collected at four times for all participants. At treatment start and end, and follow-up at 12 and 24 months after inclusion. At each time, the participants were prompted to fill in five different self-assessment forms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
Keywords
Eating disorders, Acceptance and Commitment Therapy, Body image

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
ACT is provided in 12 weekly two hour long sessions in a group setting
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating disorder symptoms
Description
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.
Time Frame
24 months follow up
Secondary Outcome Measure Information:
Title
Changes in Mindful awareness
Description
Assessed through the Mindful Attention Awareness Scale (MAAS). The MAAS consists of 15 questions, ranging from 1 to 6. A global score is calculated where higher scoring indicates more mindful awareness.
Time Frame
24 month follow up
Title
Measure of body shape preoccupations.
Description
Assessed through the Body Shape Questionnaire (BSQ), a short Swedish version consisting of 8 questions. A total score is calculated, ranging from 8 to 48, where higher scoring indicates more severe concerns.
Time Frame
24 months
Title
Measurement of body checking
Description
Assessed through the Body Checking Questionnaire (BCQ). The BCQ consist of 23 questions ranging from 1 to 5. A global score is calculated ranging from 23 to 115, where a higher scoring indicates more frequent use of behaviours related to a negative body image.
Time Frame
24 months
Title
Measure changes in self-concept
Description
Assessed through the Self-Concept Questionnaire (SCQ). The SCQ consists of 30 questions ranging from 0 to 7. A global score is calculated where higher scorings indicates a higher self-esteem.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Differences in amount of healthcare received after treatment intervention
Description
Assess the amount of received healthcare at the eating disorder clinic in terms of amounts of sessions after the intervention endpoint, and at end of follow-up.
Time Frame
24 months
Title
The participants opinions regarding the intervention
Description
After last follow up participants are asked to participate in a qualitative interview, with focus on what was helpful and not in the intervention, according to the participants own reflections
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanna Gustafsson, PhD
Organizational Affiliation
Psychiatric research centre, Orebro County Counsil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eriksbergsgarden, Orebro County Counsil
City
Orebro
State/Province
Orebro County Counsil
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27999670
Citation
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.
Results Reference
derived

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An ACT Group Intervention for ED-patients

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