NCT02058121

An ACT Group Intervention for ED-patients

Randomised Controlled Trial With Acceptance and Commitment Therapy (ACT) for Patients With Eating Disorders - a Manualised Group Therapy to Enhance Body Acceptance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Örebro County Council · Other Government
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eating Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy	ACT is provided in 12 weekly two hour long sessions in a group setting
BEHAVIORAL	Treatment as usual	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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-06-01
• Completion: 2016-08-01
• First posted: 2014-02-07
• Last updated: 2019-01-15

Locations

1 site across 1 country: Sweden