Clinical trial NCT02058121: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Keywords: Eating disorders
Acceptance and Commitment Therapy
Body image
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala University
First posted: 2014-02-07
Enrollment: 99
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Eating disorder symptoms
timeFrame: 24 months follow up
Secondary outcomes:
measure: Changes in Mindful awareness
timeFrame: 24 month follow up
measure: Measure of body shape preoccupations.
timeFrame: 24 months
measure: Measurement of body checking
timeFrame: 24 months
measure: Measure changes in self-concept
timeFrame: 24 months
Other outcomes:
measure: Differences in amount of healthcare received after treatment intervention
timeFrame: 24 months
measure: The participants opinions regarding the intervention
timeFrame: 24 months
Locations:
city: Orebro
country: Sweden
facility: Eriksbergsgarden, Orebro County Counsil
state: Orebro County Counsil
Study officials:
affiliation: Psychiatric research centre, Orebro County Counsil
name: Sanna Gustafsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.