An ACT Group Intervention for ED-patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Örebro County Council
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Sanna Aila Gustafsson, Örebro County Council
ClinicalTrials.gov Identifier:
NCT02058121
First received: February 6, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

The purpose of this study is to test if an ACT group intervention focusing on body image enhances recovery and reduces relapse in patients treated at a specialised eating disorder unit.


Condition Intervention
Eating Disorder
Behavioral: Acceptance and Commitment Therapy
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial With Acceptance and Commitment Therapy (ACT) for Patients With Eating Disorders - a Manualised Group Therapy to Enhance Body Acceptance

Resource links provided by NLM:


Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • Eating disorder according to DSM-IV at end of treatment [ Time Frame: 24 months follow up ] [ Designated as safety issue: No ]
    Assessed through EDE-Q, and diagnostic interview according to EDE.


Secondary Outcome Measures:
  • Changes in Mindful awareness [ Time Frame: 24 month follow up ] [ Designated as safety issue: No ]
    Assessed through the form Mindful Attention Awareness Scale(MAAS).

  • Measure of body shape preoccupations. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed through the Body Shape Questionnaire - measure of the body shape preoccupations typical of bulimia nervosa and anorexia nervosa.

  • Measurement of body checking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Body checking is considered a behavioral manifestation of the overevaluation of shape and weight, which is characteristic of patients with eating disorders. Assessed through the Body Checking Questionnaire.

  • Measure changes in self-concept [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed through the Self-Concept Questionnaire


Other Outcome Measures:
  • Differences in amount of healthcare received after treatment intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assess the amount of received healthcare at the eating disorder clinic in terms of amounts of sessions after the intervention endpoint.

  • The participants opinions regarding the intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acceptance and Commitment Therapy Behavioral: Acceptance and Commitment Therapy
ACT is provided in 12 weekly two hour long sessions in a group setting
Active Comparator: Treatment as usual Behavioral: Treatment as usual
Treatment as usual contains different interventions available at the clinic, such as individual therapy, group therapy, or contact with a dietician and/or physiotherapist.

Detailed Description:

The study is a RCT in which the ACT-intervention is being compared to treatment as usual. The trial started in 2010, and randomisation of patients will continue until 2014, and follow-ups will be completed in 2016.

According to analysis of power, a total of 120 patients needs to be included, 60 in each arm. Patients eligible for the interventions are offered to participate after their clinician has reported them to the head investigator. The head investigator sends a letter to the patients with information on the study. The clinician then asks the patient if the letter has been read. If the patient chooses to participate, he/she will be summoned to a information and assessment meeting. The head investigator checks that the patient understands the information, and what each study arm can mean for the patient when participating. Consent to participate is collected both verbally and written. At this meeting the patient receives an envelope which contains the randomization outcome. The patient then receives information regarding the continued treatment according to which research arm he/she is to participate in.

The treatment intervention is planned to start within 6 weeks from the first letter of information has been sent. The goal is to start treatment four weeks after randomization, to enable a positive termination of previous treatment. The participants randomized to treatment as usual continues with the treatment as planned before enrollment. Thus, they might end treatment during the study period, or continue treatment after study participation, all according to the treatment plan with the clinician.

Participants in the intervention arm start the group intervention consisting of 12 session over a period of three to four months, and an individual meeting with the group-leaders before and after the intervention. The intervention is a manualized application of the book "Lev med din kropp" [Live with your body]. Participants in need of further care after the intervention are offered continued treatment accordingly at the clinic.

If a participant chooses to terminate the intervention, or deteriorate during the intervention to the point that other treatment is needed, further treatment is agreed upon in dialogue with the patient. If needed, further assessment and physical examination is conducted in accordance to the clinics standard procedures.

Data is being 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 are prompted to fill in five different self-assessment forms, all well used and validated.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Being in the anorectic weight range
  • Lost weight (more than 3 kg) for the past two months
  • Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058121

Contacts
Contact: Sanna Aila Gustafsson, PhD +46 72-2495986 sanna.aila-gustafsson@orebroll.se
Contact: Maria Fogelkvist, PhD Student maria.fogelkvist@orebroll.se

Locations
Sweden
Eriksbergsgarden, Orebro County Counsil Recruiting
Orebro, Orebro County Counsil, Sweden, 701 85
Contact: Sanna Gustafsson, PhD    +4672-2495986    sanna.aila-gustafsson@orebroll.se   
Sponsors and Collaborators
Örebro County Council
Uppsala University
Investigators
Principal Investigator: Sanna Gustafsson, PhD Psychiatric research centre, Orebro County Counsil
  More Information

No publications provided

Responsible Party: Sanna Aila Gustafsson, Med.dr, Örebro County Council
ClinicalTrials.gov Identifier: NCT02058121     History of Changes
Other Study ID Numbers: 2009/294
Study First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:
Eating disorders
Acceptance and Commitment Therapy
Body image

Additional relevant MeSH terms:
Eating Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014