Eating DisorderNCT02058121
An ACT Group Intervention for ED-patients
A study testing Acceptance and Commitment Therapy and Treatment as usual in people with Eating Disorder, run by Örebro County Council at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Acceptance and Commitment Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Eriksbergsgarden, Orebro County Counsil
Örebro, Orebro County Counsil, 701 85
About this study
Official title: Randomised Controlled Trial With Acceptance and Commitment Therapy (ACT) for Patients With Eating Disorders - a Manualised Group Therapy to Enhance Body Acceptance
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.
- Conditions
- Eating Disorder
- Being tested
- Acceptance and Commitment Therapy, Treatment as usual
- Keywords
- Eating disorders, Acceptance and Commitment Therapy, Body image
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
ACT is provided in 12 weekly two hour long sessions in a group setting
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Not described Receives: Behavioral: Acceptance and Commitment Therapy |
| Treatment as usual | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months follow up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Sanna Aila Gustafsson, Örebro County Council
- Investigators
- Sanna Gustafsson, PhD, Principal investigator, Psychiatric research centre, Orebro County Counsil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058121
- Sponsor's protocol ID
- 2009/294
- Status last verified
- Jan 2019
- First submitted
- 6 Feb 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial With Acceptance and Commitment Therapy (ACT) for Patients With Eating Disorders - a Manualised Group Therapy to Enhance Body Acceptance
- ClinicalTrials.gov ID
- NCT02058121
- Acronym / sponsor ID
- 2009/294
- Conditions
- Eating Disorder
- Keywords
- Eating disorders, Acceptance and Commitment Therapy, Body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Uppsala University
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment Therapy |
| Treatment as usual | Active comparator | Behavioral: Treatment as usual |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Having physical or psychiatric complicating factors of such severity that these conditions needed to be addressed during the treatment period (12 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyACT is provided in 12 weekly two hour long sessions in a group setting | Behavioural | Acceptance and Commitment Therapy |
| Treatment as usualTreatment as usual contains different interventions available at the clinic, such as individual therapy, group therapy, or contact with a physician, dietician and/or physiotherapist. | Behavioural | Treatment as usual |
Primary outcome
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.
4 secondary outcomes
Changes in Mindful awareness
Time frame: 24 month follow up
Measure of body shape preoccupations.
Time frame: 24 months
Measurement of body checking
Time frame: 24 months
Measure changes in self-concept
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 27999670Fogelkvist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanna Gustafsson, PhD principal investigator
Psychiatric research centre, Orebro County Counsil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Treatment as usual in people with Eating Disorder, run by Örebro County Council at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorder symptoms (time frame: 24 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.