ClinicalTrials.gg
CompletedNCT02058121Updated Jan 15, 2019

An ACT Group Intervention for ED-patients

An interventional study of Acceptance and Commitment Therapy and Treatment as usual in Eating Disorder, sponsored by Örebro County Council. Completed at 1 site in Sweden. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Örebro County Council · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Feeding and Eating Disorders with a site in Sweden — 10 open to participants now, 11 under way, none of them phase 3. Feeding and Eating Disorders · Sweden.

Enrollment
4th of 12
99 · median 50
Started
2010
the only one that year
No phase
11 of 22
5 open now
Registered
4th of 22
by date
Lead sponsor
1 of 22
Örebro County Council

Among the 22 studies in Feeding and Eating Disorders with a site in Sweden, this one is the 4th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2010, is one of 11 with no phase, and was the 4th registered.

Feeding and Eating Disorders

645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.

Browse Feeding and Eating Disorders studies →

Open to participants now

10 of the 22 studies in Feeding and Eating Disorders with a site in Sweden are open now. Recruiting first, the newest first:

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All 10 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 101 Feeding and Eating Disorders studies recruiting now, 31 (31%) set no upper age limit and 68 (67%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.

This study: 16 Years to 50 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Eating Disorder

Keywords

  • Eating disorders
  • Acceptance and Commitment Therapy
  • Body image
04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with an eating disorder according to (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

Exclusion Criteria:

  • Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    Acceptance and Commitment Therapy

    Behavioral: Acceptance and Commitment Therapy

  • Active comparator
    Treatment as usual

    Behavioral: Treatment as usual

Interventions

  • BehavioralAcceptance and Commitment Therapy

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

  • BehavioralTreatment 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months follow up

Secondary outcomes

  1. 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.

    Time frame: 24 month follow up

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 24 months

  4. 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.

    Time frame: 24 months

Other outcomes

  1. Differences in amount of healthcare received after treatment intervention

    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.

    Time frame: 24 months

  2. The participants opinions regarding the intervention

    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

    Time frame: 24 months

07

Study locations

1 site
  • Eriksbergsgarden, Orebro County Counsil
    Orebro, Orebro County Counsil 701 85, Sweden
08

References and documents

Publications

  • 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. PubMed 27999670 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Jun 2014 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2014
First posted
Feb 7, 2014
Start
Jan 2010
Primary completionActual
Jun 2014
CompletionActual
Aug 2016
Last update
Jan 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02058121
Lead sponsor
Örebro County Council
Collaborators
Uppsala University
Responsible party
Sanna Aila Gustafsson (Med.dr, Örebro County Council) — Principal investigator
First posted
Feb 7, 2014
Start date
Jan 2010
Primary completion
Jun 2014
Completion
Aug 2016
Last update
Jan 15, 2019

Study contacts

Sanna Gustafsson, PhD
principal investigator · Psychiatric research centre, Orebro County Counsil

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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