Anorexia NervosaNCT02054364
Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
A study testing FBT and CRT and FBT and art therapy in people with Anorexia Nervosa, run by Stanford University at 1 site in United States.
Trial summary
This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- FBT and CRT and FBT and art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 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 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets DSM-IV criteria for anorexia nervosa Lives with at least one English-speaking parent who is willing to participate Medically Stable Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English
Who cannot join
- Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.
- Conditions
- Anorexia Nervosa
- Being tested
- FBT and CRT, FBT and art therapy
- Keywords
- Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy, Cognitive Remediation Therapy, CRT
- 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.
FBT and CRTBehavioural
Also called Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT)
FBT and art therapyBehavioural
Also called Family-Based Treatment (FBT) combined with art therapy.
| Study group | Role | What they receive |
|---|---|---|
| FBT and CRT | Experimental | Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each) Receives: Behavioral: FBT and CRT |
| FBT and art therapy | Experimental | Family-Based Treatment combined with art therapy (15 sessions of each) Receives: Behavioral: FBT and art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full remission from AN (%MBW>95)
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
Measured: End of Treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completionNov 2016
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 Stanford 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
- Investigators
- James Lock, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054364
- Sponsor's protocol ID
- 1R34MH101281
- Other IDs
- Grant Funding Number (NIH)
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
- ClinicalTrials.gov ID
- NCT02054364
- Acronym / sponsor ID
- 1R34MH101281
- Conditions
- Anorexia Nervosa
- Keywords
- Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy, Cognitive Remediation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 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.
This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT and CRT | Experimental | Behavioral: FBT and CRTFamily-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each) |
| FBT and art therapy | Experimental | Behavioral: FBT and art therapyFamily-Based Treatment combined with art therapy (15 sessions of each) |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Meets DSM-IV criteria for anorexia nervosa Lives with at least one English-speaking parent who is willing to participate Medically Stable Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English
Key exclusion criteria (1 listed)
- Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight
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 |
|---|---|---|
| FBT and CRTAlso: Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT) | Behavioural | FBT and CRT |
| FBT and art therapyAlso: Family-Based Treatment (FBT) combined with art therapy. | Behavioural | FBT and art therapy |
Primary outcome
Full remission from AN (%MBW>95)
Time frame: End of Treatment (6 months)
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
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 28 Apr 2017.
- Program informationLink provided by the sponsor.
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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.
James Lock, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBT and CRT and FBT and art therapy in people with Anorexia Nervosa, run by Stanford 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 1 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 28 Apr 2017. 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?
Full remission from AN (%MBW>95) (time frame: End of Treatment (6 months)). 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 28 Apr 2017.