An ACT Group Intervention for ED-patients
This trial is active, not recruiting.
|Treatments||acceptance and commitment therapy, treatment as usual|
|Sponsor||Örebro County Council|
|Start date||January 2010|
|End date||June 2014|
|Trial size||120 participants|
|Trial identifier||NCT02058121, 2009/294|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Eating disorder according to DSM-IV at end of treatment
time frame: 24 months follow up
Changes in Mindful awareness
time frame: 24 month follow up
Measure of body shape preoccupations.
time frame: 24 months
Measurement of body checking
time frame: 24 months
Measure changes in self-concept
time frame: 24 months
Male or female participants from 16 years up to 50 years old.
- 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
- 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).
|Official title||Randomised Controlled Trial With Acceptance and Commitment Therapy (ACT) for Patients With Eating Disorders - a Manualised Group Therapy to Enhance Body Acceptance|
|Principal investigator||Sanna Gustafsson, PhD|
|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.|
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