Anorexia NervosaASFTNCT01274416
Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa
A study testing Acceptance and Commitment Therapy and Parent Skills Training in people with Anorexia Nervosa and Subthreshold Anorexia Nervosa, run by Duke University at 1 site in United States.
Trial summary
The investigators are trying to learn the most effective way to treat an adolescent's eating disorder and how best to involve the parents or caregivers in this process. Typically, parents and their child are seen together in therapy. However, this can sometimes be difficult for both the parents and the adolescent. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa, Subthreshold Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Primary Restriction
- What is being tested?
- Acceptance and Commitment Therapy and Parent Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2012
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent is between 12-18 years of age and living in home with caregivers
- Parent or primary caregiver willing to attend therapy sessions
- Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype) or subthreshold AN (relaxation of weight criterion to 90% of ideal body weight as determined by weight history and CDC growth curves) or eating disorder not otherwise specified (with restricting as the primary symptom) according to the DSM-IV TR
- Adolescent is appropriate for outpatient care and receives medical clearance from a primary care physician
Who cannot join
- Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, bi-polar disorder, or substance dependence
- Caregiver or adolescent with diagnosis of mental retardation or a pervasive developmental disorder
- Adolescent with a diagnosis of eating disorder not otherwise specified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns but a BMI greater than 90% ideal weight (as determined by weight history and CDC growth curves)
- Adolescent with extreme malnutrition or other medical complications/diagnoses that require a higher level of care
- Acute suicide risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27713
About this study
The investigators are trying to learn the most effective way to treat an adolescent's eating disorder and how best to involve the parents or caregivers in this process.
Typically, parents and their child are seen together in therapy. However, this can sometimes be difficult for both the parents and the adolescent. Both parents and adolescents have different concerns and are struggling with different aspects of the eating disorder. Therefore, the treatment in this study involves the parents in treatment, but does not have therapy sessions with the parents and child together.
Read more
The purpose of this study is to develop this investigational type of treatment (separated family treatment), and see what works best for adolescents and their families.
Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first 16 weeks families separate therapy sessions weekly. For the last 8 weeks families meet with the therapist bi-weekly. These bi-weekly sessions are conjoint - that is, adolescents and parents will meet with the therapist together. This is to help parents and adolescents come together as a family to continue to aid the adolescent in the treatment of his/her eating disorder.
The investigators hypothesize that adolescents who receive ASFT will demonstrate improvement in eating disorder symptoms and body-mass index, that caregivers who participate in ASFT will demonstrate decreased distress and caregiver burden, that increases in psychological acceptance will be seen for both adolescents and caregivers post-treatment, and that treatment will be viewed as both credible and acceptable to both caregiver and adolescent
Read the detailed description
The purpose of this study is to develop and gather preliminary data on an acceptance-based behavioral treatment for adolescents with anorexia nervosa (AN) that is delivered in a separated family format. The treatment will combine a parent's skills curriculum that has demonstrated preliminary effectiveness in the treatment of AN, with a novel adolescent component based on Acceptance and Commitment Therapy (ACT). ACT has been found to be useful in the treatment of an array of psychological difficulties, and may be particularly well-suited for the cognitive and behavioral avoidance and rigidity that characterizes individuals with AN and their caregivers.
- Conditions
- Anorexia Nervosa, Subthreshold Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Primary Restriction
- Being tested
- Acceptance and Commitment Therapy, Parent Skills Training
- Keywords
- Anorexia Nervosa, Eating Disorder, Treatment, Acceptance and Commitment Therapy, Separated Family Treatment
- Medical subject headings
- Anorexia Nervosa, 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
The stated goal of this intervention is to increase willingness to experience difficult thoughts, feelings, and bodily sensations in order to engage in flexible action.
Parent Skills TrainingBehavioural
Skills Training for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: 9 months (6 months active treatment, 3 months follow-up)
Secondary outcomes (1)
Eating Disorder Examination (16.0D)
Measures eating disorder symptoms.
Measured: 1 year (6 months of treatment and 3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda Merwin, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274416
- Sponsor's protocol ID
- Pro00016058
- Acronym
- ASFT
- Status last verified
- Aug 2013
- First submitted
- 9 Jan 2011
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance-Based Separated Family Treatment for Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01274416
- Acronym / sponsor ID
- ASFT / Pro00016058
- Conditions
- Anorexia Nervosa, Subthreshold Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Primary Restriction
- Keywords
- Anorexia Nervosa, Eating Disorder, Treatment, Acceptance and Commitment Therapy, Separated Family Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Jan 2011 (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 investigators are trying to learn the most effective way to treat an adolescent's eating disorder and how best to involve the parents or caregivers in this process.
Typically, parents and their child are seen together in therapy. However, this can sometimes be difficult for both the parents and the adolescent. Both parents and adolescents have different concerns and are struggling with different aspects of the eating disorder. Therefore, the treatment in this study involves the parents in treatment, but does not have therapy sessions with the parents and child together.
The purpose of this study is to develop this investigational type of treatment (separated family treatment), and see what works best for adolescents and their families.
Participants meet with a therapist for 20 sessions over the course of 24 weeks. For the first 16 weeks families separate therapy sessions weekly. For the last 8 weeks families meet with the therapist bi-weekly. These bi-weekly sessions are conjoint - that is, adolescents and parents will meet with the therapist together. This is to help parents and adolescents come together as a family to continue to aid the adolescent in the treatment of his/her eating disorder.
The investigators hypothesize that adolescents who receive ASFT will demonstrate improvement in eating disorder symptoms and body-mass index, that caregivers who participate in ASFT will demonstrate decreased distress and caregiver burden, that increases in psychological acceptance will be seen for both adolescents and caregivers post-treatment, and that treatment will be viewed as both credible and acceptable to both caregiver and adolescent
Detailed description
The purpose of this study is to develop and gather preliminary data on an acceptance-based behavioral treatment for adolescents with anorexia nervosa (AN) that is delivered in a separated family format. The treatment will combine a parent's skills curriculum that has demonstrated preliminary effectiveness in the treatment of AN, with a novel adolescent component based on Acceptance and Commitment Therapy (ACT). ACT has been found to be useful in the treatment of an array of psychological difficulties, and may be particularly well-suited for the cognitive and behavioral avoidance and rigidity that characterizes individuals with AN and their caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent is between 12-18 years of age and living in home with caregivers
- Parent or primary caregiver willing to attend therapy sessions
- Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype) or subthreshold AN (relaxation of weight criterion to 90% of ideal body weight as determined by weight history and CDC growth curves) or eating disorder not otherwise specified (with restricting as the primary symptom) according to the DSM-IV TR
- Adolescent is appropriate for outpatient care and receives medical clearance from a primary care physician
Key exclusion criteria (5 listed)
- Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, bi-polar disorder, or substance dependence
- Caregiver or adolescent with diagnosis of mental retardation or a pervasive developmental disorder
- Adolescent with a diagnosis of eating disorder not otherwise specified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns but a BMI greater than 90% ideal weight (as determined by weight history and CDC growth curves)
- Adolescent with extreme malnutrition or other medical complications/diagnoses that require a higher level of care
- Acute suicide risk
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 TherapyThe stated goal of this intervention is to increase willingness to experience difficult thoughts, feelings, and bodily sensations in order to engage in flexible action. | Behavioural | – |
| Parent Skills TrainingSkills Training for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation. | Behavioural | – |
Primary outcome
Body Mass Index
Time frame: 9 months (6 months active treatment, 3 months follow-up)
1 secondary outcome
Eating Disorder Examination (16.0D)
Time frame: 1 year (6 months of treatment and 3 months follow-up)
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 14 Aug 2013.
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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.
Rhonda Merwin, PhD principal investigator
Assistant Professor
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 Parent Skills Training in people with Anorexia Nervosa and Subthreshold Anorexia Nervosa, run by Duke University at 1 site in United States.
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 4 inclusion and 5 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 14 Aug 2013. 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 United States. 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?
Body Mass Index (time frame: 9 months (6 months active treatment, 3 months follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.