Anorexia NervosaNCT01174602
Inpatient Exposure Therapy and Response Prevention & Cognitive Remediation Therapy for Anorexia Nervosa
A study testing Exposure Therapy for AN (AN-EX/RP) and Cognitive Remediation Therapy in people with Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Exposure Therapy for AN (AN-EX/RP) and Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2014
- 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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
- Subjects will have achieved 85% of ideal body weight (IBW)
- Age 16-45 years
- No acute medical condition
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- Psychotic or bipolar I disorder
- Substance abuse or dependence in the last 6 months
- Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
- Significant co-morbid depression
- Significant medical problems that would introduce additional risk related to research or interfere with participation, e.g. SBP>140, DBP>90, HR>100 for a sustained period.
- Active suicidal intent
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Randomized Controlled Trial of Inpatient Exposure Therapy and Response Prevention for Anorexia Nervosa
Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior.
Read the detailed description
Anorexia nervosa (AN) is a serious illness associated with substantial morbidity and a mortality rate among the highest of any psychiatric illness. The rate of relapse is disturbingly high, with up to 50% of patients requiring re-hospitalization within a year of discharge. Current treatments are inadequate in helping older adolescents and adults achieve sustained recovery. Importantly, eating behavior remains disturbed after weight restoration: patients demonstrate restrictive eating in their self-selected foods and in standardized meals, and caloric intake in standardized meals is inversely related to pre-meal anxiety. Emerging data suggest that eating behavior is particularly important in post-hospital course, and that significantly altering eating behavior is critical in improving outcome for these individuals. Furthermore, caloric intake in standardized meals has been shown to be related to pre-meal anxiety. This study evaluates the potential utility of two psychotherapeutic interventions in improving eating behavior prior to hospital discharge. Each individual receives, in random order, Cognitive Remediation Therapy for 4 weeks and Exposure and Response Prevention for AN for 4 weeks. The investigators hypothesize that these interventions will lead to improvement in eating behavior, measured by food diaries and standardized meals.
- Conditions
- Anorexia Nervosa
- Being tested
- Exposure Therapy for AN (AN-EX/RP), Cognitive Remediation Therapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Therapy for AN (AN-EX/RP)Behavioural
12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.
Cognitive Remediation TherapyBehavioural
12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Therapy for AN (AN-EX/RP) | Experimental | Exposure Therapy and Ritual Prevention (AN-EX/RP) includes 12 sessions of confronting feared eating situations without the use of anxiety reducing behaviors. Receives: Behavioral: Exposure Therapy for AN (AN-EX/RP) |
| Cognitive Remediation Therapy | Active comparator | Cognitive Remediation Therapy (CRT) Receives: Behavioral: Cognitive Remediation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Behavior
Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.
Measured: 4 weeks
Secondary outcomes (3)
Psychological Improvement
The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Measured: 4 weeks
Psychological Improvement
The impact of these interventions on psychological state, including anxiety and thinking patterns, will be measured.
Measured: 8 weeks
Eating Behavior
Laboratory meal after crossover condition.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionOct 2014
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.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression, The Hilda & Preston Davis Foundation
- Responsible party
- Sponsor
- Investigators
- Joanna Steinglass, MD, Principal investigator, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174602
- Sponsor's protocol ID
- 6010
- Other IDs
- 1R01MH082736-01
- Status last verified
- Jan 2015
- First submitted
- 29 Jul 2010
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Inpatient Exposure Therapy and Response Prevention for Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01174602
- Acronym / sponsor ID
- 6010
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression, The Hilda & Preston Davis Foundation
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Aug 2010 (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.
Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior.
Detailed description
Anorexia nervosa (AN) is a serious illness associated with substantial morbidity and a mortality rate among the highest of any psychiatric illness. The rate of relapse is disturbingly high, with up to 50% of patients requiring re-hospitalization within a year of discharge. Current treatments are inadequate in helping older adolescents and adults achieve sustained recovery. Importantly, eating behavior remains disturbed after weight restoration: patients demonstrate restrictive eating in their self-selected foods and in standardized meals, and caloric intake in standardized meals is inversely related to pre-meal anxiety. Emerging data suggest that eating behavior is particularly important in post-hospital course, and that significantly altering eating behavior is critical in improving outcome for these individuals. Furthermore, caloric intake in standardized meals has been shown to be related to pre-meal anxiety. This study evaluates the potential utility of two psychotherapeutic interventions in improving eating behavior prior to hospital discharge. Each individual receives, in random order, Cognitive Remediation Therapy for 4 weeks and Exposure and Response Prevention for AN for 4 weeks. The investigators hypothesize that these interventions will lead to improvement in eating behavior, measured by food diaries and standardized meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Therapy for AN (AN-EX/RP) | Experimental | Behavioral: Exposure Therapy for AN (AN-EX/RP)Exposure Therapy and Ritual Prevention (AN-EX/RP) includes 12 sessions of confronting feared eating situations without the use of anxiety reducing behaviors. |
| Cognitive Remediation Therapy | Active comparator | Behavioral: Cognitive Remediation TherapyCognitive Remediation Therapy (CRT) |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
- Subjects will have achieved 85% of ideal body weight (IBW)
- Age 16-45 years
- No acute medical condition
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Key exclusion criteria (6 listed)
- Psychotic or bipolar I disorder
- Substance abuse or dependence in the last 6 months
- Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
- Significant co-morbid depression
- Significant medical problems that would introduce additional risk related to research or interfere with participation, e.g. SBP>140, DBP>90, HR>100 for a sustained period.
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 |
|---|---|---|
| Exposure Therapy for AN (AN-EX/RP)12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week. | Behavioural | Exposure Therapy for AN (AN-EX/RP) |
| Cognitive Remediation Therapy12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week. | Behavioural | Cognitive Remediation Therapy |
Primary outcome
Eating Behavior
Time frame: 4 weeks
Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.
3 secondary outcomes
Psychological Improvement
Time frame: 4 weeks
Psychological Improvement
Time frame: 8 weeks
Eating Behavior
Time frame: 8 weeks
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 29 Jan 2015.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
Joanna Steinglass, MD principal investigator
NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy for AN (AN-EX/RP) and Cognitive Remediation Therapy in people with Anorexia Nervosa, run by New York State Psychiatric Institute 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 5 inclusion and 6 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 29 Jan 2015. 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?
Eating Behavior (time frame: 4 weeks). 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 29 Jan 2015.