Anorexia NervosaREACHNCT02382055
Changing Habits in Anorexia Nervosa: Novel Treatment Development
A study testing REACH, Supportive Psychotherapy and Inpatient Behavioral Treatment in people with Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The investigators are examining what types of psychotherapy are most helpful for patients as they undergo weight restoration treatment for anorexia nervosa. In this study, patients who are receiving care on our inpatient unit will also receive 4 weeks of one two types of psychotherapy: Supportive Psychotherapy or… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- REACH, Supportive Psychotherapy and Inpatient Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2017
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM5 diagnosis of anorexia nervosa
- Age>= 18
- Medically stable
- Able to provide informed consent
Who cannot join
- Other psychiatric disorder requiring acute treatment
- Serious medical illness
- Antipsychotic medication
- Severe cognitive impairment
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: Changing Habits in Anorexia Nervosa
The investigators are examining what types of psychotherapy are most helpful for patients as they undergo weight restoration treatment for anorexia nervosa. In this study, patients who are receiving care on our inpatient unit will also receive 4 weeks of one two types of psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.
Read the detailed description
Patients will be receiving specialized inpatient treatment for anorexia nervosa on the Eating Disorders Unit at the New York State Psychiatric Institute, where care is provided free of charge.
Study procedures will begin after one week of acclimating to the inpatient unit. Patients will be randomly assigned to receive either Supportive Psychotherapy (focused on the transition to the inpatient unit) or REACH (focused on changing routines or habits that have become part of the eating disorder). Each treatment consists of 12-sessions, delivered 2-3 times per week.
Before and after treatment, patients will be asked to participate in interviews, questionnaires, and a lunch meal.
- Conditions
- Anorexia Nervosa
- Being tested
- REACH, Supportive Psychotherapy, Inpatient Behavioral Treatment
- Keywords
- Eating Disorders, Psychotherapy, Anorexia Nervosa, 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.
REACHBehavioural
REACH is a 12-session intervention, delivered 2-3 times per week for 45 minutes. The treatment focuses on identifying and changing behaviors and routines that have become entrenched and help perpetuate the illness.
Supportive PsychotherapyBehavioural
The Supportive Psychotherapy is based on the Specialist Supportive Care (McIntosh et al, 2005), and modified for the current research procedures. Supportive Psychotherapy is a 12-session intervention, delivered 2-3 times per week as 45 minute sessions, focusing on symptoms of anorexia nervosa during the transition to the inpatient unit.
Inpatient Behavioral TreatmentBehavioural
Inpatient treatment at the NYSPI is a behaviorally-based treatment program for anorexia nervosa. This is a non-research, clinical intervention for individuals with anorexia nervosa.
| Study group | Role | What they receive |
|---|---|---|
| REACH | Experimental | Psychotherapy Receives: Behavioral: REACH; Behavioral: Inpatient Behavioral Treatment |
| Supportive Psychotherapy | Active comparator | Psychotherapy Receives: Behavioral: Supportive Psychotherapy; Behavioral: Inpatient Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habit strength as measured by self report scales
Measured: 4 weeks
Secondary outcomes (2)
Eating behavior as measured by laboratory meal
Measured: 4 weeks
Eating behavior as measured by meal observation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Steinglass, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382055
- Sponsor's protocol ID
- 7072
- Acronym
- REACH
- Status last verified
- Sep 2017
- First submitted
- 29 Jan 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Foerde K, Knowlton BJ, Poldrack RA. Modulation of competing memory systems by distraction. Proc Natl Acad Sci U S A. 2006 Aug 1;103(31):11778-83. doi: 10.1073/pnas.0602659103. Epub 2006 Jul 25.
PubMed 16868087McIntosh VV, Jordan J, Carter FA, Luty SE, McKenzie JM, Bulik CM, Frampton CM, Joyce PR. Three psychotherapies for anorexia nervosa: a randomized, controlled trial. Am J Psychiatry. 2005 Apr;162(4):741-7. doi: 10.1176/appi.ajp.162.4.741.
PubMed 15800147McGowan L, Cooke LJ, Gardner B, Beeken RJ, Croker H, Wardle J. Healthy feeding habits: efficacy results from a cluster-randomized, controlled exploratory trial of a novel, habit-based intervention with parents. Am J Clin Nutr. 2013 Sep;98(3):769-77. doi: 10.3945/ajcn.112.052159. Epub 2013 Jul 17.
PubMed 23864536Walsh BT. The enigmatic persistence of anorexia nervosa. Am J Psychiatry. 2013 May;170(5):477-84. doi: 10.1176/appi.ajp.2012.12081074.
PubMed 23429750
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Habits in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02382055
- Acronym / sponsor ID
- REACH / 7072
- Conditions
- Anorexia Nervosa
- Keywords
- Eating Disorders, Psychotherapy, Anorexia Nervosa, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Mar 2015 (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 examining what types of psychotherapy are most helpful for patients as they undergo weight restoration treatment for anorexia nervosa. In this study, patients who are receiving care on our inpatient unit will also receive 4 weeks of one two types of psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.
Detailed description
Patients will be receiving specialized inpatient treatment for anorexia nervosa on the Eating Disorders Unit at the New York State Psychiatric Institute, where care is provided free of charge.
Study procedures will begin after one week of acclimating to the inpatient unit. Patients will be randomly assigned to receive either Supportive Psychotherapy (focused on the transition to the inpatient unit) or REACH (focused on changing routines or habits that have become part of the eating disorder). Each treatment consists of 12-sessions, delivered 2-3 times per week.
Before and after treatment, patients will be asked to participate in interviews, questionnaires, and a lunch meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REACH | Experimental | Behavioral: REACH, Behavioral: Inpatient Behavioral TreatmentPsychotherapy |
| Supportive Psychotherapy | Active comparator | Behavioral: Supportive Psychotherapy, Behavioral: Inpatient Behavioral TreatmentPsychotherapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM5 diagnosis of anorexia nervosa
- Age>= 18
- Medically stable
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Other psychiatric disorder requiring acute treatment
- Serious medical illness
- Antipsychotic medication
- Severe cognitive impairment
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 |
|---|---|---|
| REACHREACH is a 12-session intervention, delivered 2-3 times per week for 45 minutes. The treatment focuses on identifying and changing behaviors and routines that have become entrenched and help perpetuate the illness. | Behavioural | REACH |
| Supportive PsychotherapyThe Supportive Psychotherapy is based on the Specialist Supportive Care (McIntosh et al, 2005), and modified for the current research procedures. Supportive Psychotherapy is a 12-session intervention, delivered 2-3 times per week as 45 minute sessions, focusing on symptoms of anorexia nervosa during the transition to the inpatient unit. | Behavioural | Supportive Psychotherapy |
| Inpatient Behavioral TreatmentInpatient treatment at the NYSPI is a behaviorally-based treatment program for anorexia nervosa. This is a non-research, clinical intervention for individuals with anorexia nervosa. | Behavioural | REACH, Supportive Psychotherapy |
Primary outcome
Habit strength as measured by self report scales
Time frame: 4 weeks
2 secondary outcomes
Eating behavior as measured by laboratory meal
Time frame: 4 weeks
Eating behavior as measured by meal observation
Time frame: 4 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 13 Sep 2017.
- Background: PubMed 16868087Foerde K, Knowlton BJ, Poldrack RA. Modulation of competing memory systems by distraction. Proc Natl Acad Sci U S A. 2006 Aug 1;103(31):11778-83. doi: 10.1073/pnas.0602659103. Epub 2006 Jul 25.
- Background: PubMed 15800147McIntosh VV, Jordan J, Carter FA, Luty SE, McKenzie JM, Bulik CM, Frampton CM, Joyce PR. Three psychotherapies for anorexia nervosa: a randomized, controlled trial. Am J Psychiatry. 2005 Apr;162(4):741-7. doi: 10.1176/appi.ajp.162.4.741.
- Background: PubMed 23864536McGowan L, Cooke LJ, Gardner B, Beeken RJ, Croker H, Wardle J. Healthy feeding habits: efficacy results from a cluster-randomized, controlled exploratory trial of a novel, habit-based intervention with parents. Am J Clin Nutr. 2013 Sep;98(3):769-77. doi: 10.3945/ajcn.112.052159. Epub 2013 Jul 17.
- Background: PubMed 23429750Walsh BT. The enigmatic persistence of anorexia nervosa. Am J Psychiatry. 2013 May;170(5):477-84. doi: 10.1176/appi.ajp.2012.12081074.
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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.
Joanna Steinglass, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH, Supportive Psychotherapy and Inpatient Behavioral Treatment 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 4 inclusion and 4 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 13 Sep 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?
Habit strength as measured by self report scales (time frame: 4 weeks). 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 NCT02382055, which also lists 4 linked publications.
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 13 Sep 2017.