Anorexia NervosaRePANNCT01611220
Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa
A study testing RePAN in people with Anorexia Nervosa, run by Villa Garda Hospital at 1 site in Italy.
Trial summary
Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Read more about this study
- Who is it for?
- Ages 13 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- RePAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to Oct 2018
- 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 13 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Body Mass Index ≥ 18.5
- Anorexia Nervosa patients admitted to inpatient treatment
- Written informed consent
Who cannot join
- Male
- Schizophrenia or other psychiatric disorders
- Substance abuse
- Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
- Absence of medical treatment (drugs) that may hamper the interpretation of results
- Pregnancy or plan to get pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.
Read the detailed description
Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a high percentage of patients relapse following discharge. The aim of the study was to assess the effect of a relapse prevention program during the last phase of inpatient treatment. Patients, when they achieve a BMI of 18.5, are randomly allocated to complete the standard cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight relapse prevention groups based on the cognitive dissonance. The intervention has been derived by the selective and indicated prevention programs using a dissonance-based approach. This intervention showed to be effective in reducing the risk for eating pathology onset. The primary outcome of the study is to assess the number of patients allocated to the two condition with a BMI equal or greater than 18.5 at 12-months after discharge.
- Conditions
- Anorexia Nervosa
- Being tested
- RePAN
- Keywords
- Anorexia Nervosa, Relapse prevention, Cognitive Dissonance, Inpatient treatment, Cognitive behavior 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.
RePANBehavioural
Also called Dissonance relapse prevention
The dissonance relapse prevention intervention consists of eight groups conducted by a psychologist who involves participants in interactive activities aimed to prevent relapse after discharge from the inpatient treatment
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard cognitive behavior inpatient treatment |
| RePAN | Experimental | Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups Receives: Behavioral: RePAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
The main outcome is to assess the number of patients with good BMI outcome (BMI ≥ 18.5) at 12-month follow-up end in the two arm conditions.
Measured: 1 year
Secondary outcomes (1)
Eating disorder Examination (EDE)
Number of patients with "full remission" defined as having a global EDE score below 1SD above the community mean (1.74) and a BMI ≥ 18.5.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2018
- Study completionOct 2018
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Garda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Dalle Grave, Villa Garda Hospital
- Investigators
- Riccardo Dalle Grave, MD, Principal investigator, Department of Eating and Weight Disorders, Villa Garda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611220
- Sponsor's protocol ID
- USL22#03/12-CEP329
- Acronym
- RePAN
- Status last verified
- Oct 2020
- First submitted
- 25 May 2012
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stice E, Marti CN, Spoor S, Presnell K, Shaw H. Dissonance and healthy weight eating disorder prevention programs: long-term effects from a randomized efficacy trial. J Consult Clin Psychol. 2008 Apr;76(2):329-40. doi: 10.1037/0022-006X.76.2.329.
PubMed 18377128
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01611220
- Acronym / sponsor ID
- RePAN / USL22#03/12-CEP329
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Relapse prevention, Cognitive Dissonance, Inpatient treatment, Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Villa Garda HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Jun 2012 (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.
Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.
Detailed description
Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a high percentage of patients relapse following discharge. The aim of the study was to assess the effect of a relapse prevention program during the last phase of inpatient treatment. Patients, when they achieve a BMI of 18.5, are randomly allocated to complete the standard cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight relapse prevention groups based on the cognitive dissonance. The intervention has been derived by the selective and indicated prevention programs using a dissonance-based approach. This intervention showed to be effective in reducing the risk for eating pathology onset. The primary outcome of the study is to assess the number of patients allocated to the two condition with a BMI equal or greater than 18.5 at 12-months after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard cognitive behavior inpatient treatment |
| RePAN | Experimental | Behavioral: RePANStandard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Body Mass Index ≥ 18.5
- Anorexia Nervosa patients admitted to inpatient treatment
- Written informed consent
Key exclusion criteria (6 listed)
- Male
- Schizophrenia or other psychiatric disorders
- Substance abuse
- Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)
- Absence of medical treatment (drugs) that may hamper the interpretation of results
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 |
|---|---|---|
| RePANAlso: Dissonance relapse preventionThe dissonance relapse prevention intervention consists of eight groups conducted by a psychologist who involves participants in interactive activities aimed to prevent relapse after discharge from the inpatient treatment | Behavioural | RePAN |
Primary outcome
Body Mass Index (BMI)
Time frame: 1 year
The main outcome is to assess the number of patients with good BMI outcome (BMI ≥ 18.5) at 12-month follow-up end in the two arm conditions.
1 secondary outcome
Eating disorder Examination (EDE)
Time frame: 1 year
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 8 Oct 2020.
- Background: PubMed 18377128Stice E, Marti CN, Spoor S, Presnell K, Shaw H. Dissonance and healthy weight eating disorder prevention programs: long-term effects from a randomized efficacy trial. J Consult Clin Psychol. 2008 Apr;76(2):329-40. doi: 10.1037/0022-006X.76.2.329.
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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.
Riccardo Dalle Grave, MD principal investigator
Department of Eating and Weight Disorders, Villa Garda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RePAN in people with Anorexia Nervosa, run by Villa Garda Hospital at 1 site in Italy.
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 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 8 Oct 2020. 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 Italy. 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 (BMI) (time frame: 1 year). 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 NCT01611220, 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 8 Oct 2020.