An ACT Group Intervention for ED-patients

Study Overview
=================
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.

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

Conditions
-----------------
Eating Disorder

Intervention / Treatment
-----------------
* Behavioral: Acceptance and Commitment Therapy
* Behavioral: Treatment as usual


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy<br> | Behavioral: Acceptance and Commitment Therapy<br>* ACT is provided in 12 weekly two hour long sessions in a group setting<br>|
| Active Comparator: Treatment as usual<br> | Behavioral: Treatment as usual<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 month follow up | 
| 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. | 24 months | 
| 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. | 24 months | 
| 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. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eating disorders, Acceptance and Commitment Therapy, Body image