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Completed

NCT Number: NCT02058121

An ACT Group Intervention for ED-patients

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.

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Key information

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eriksbergsgarden, Orebro County Counsil

Örebro, Orebro County Counsil, 701 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

ACT is provided in 12 weekly two hour long sessions in a group setting

Treatment as Usual

Behavioral

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.

Primary outcomes

  1. Eating disorder symptoms

    Time frame: 24 months follow up

    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.

Secondary outcomes

  1. Changes in Mindful awareness

    Time frame: 24 month follow up

    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.

  2. Measure of body shape preoccupations.

    Time frame: 24 months

    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.

  3. Measurement of body checking

    Time frame: 24 months

    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.

  4. Measure changes in self-concept

    Time frame: 24 months

    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.

Other outcomes

  1. Differences in amount of healthcare received after treatment intervention

    Time frame: 24 months

    Assess the amount of received healthcare at the eating disorder clinic in terms of amounts of sessions after the intervention endpoint, and at end of follow-up.

  2. The participants opinions regarding the intervention

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Collaborators

  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Feb 7, 2014
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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