Anorexia NervosaPhase 3NCT00220662
The Efficacy of Readiness and Motivation Therapy in Individuals With Anorexia Nervosa and Bulimia Nervosa
A Phase 3 study testing Readiness and Motivation Therapy in people with Anorexia Nervosa and Bulimia Nervosa, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
This research examines the efficacy of a 5-session individual psychotherapy intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Readiness and Motivation Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2000to Jun 2006
- Phase
- Phase 3
- 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
- meet DSM-IV diagnostic criteria for anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified
Who cannot join
- acute medical crisis
- acute psychiatric crisis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Eating Disorders Program, St. Paul's Hospital 1081 Burrard St.
Vancouver, British Columbia, V6Z 1Y6
About this study
This research examines the efficacy of a 5-session individual psychotherapy intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified.
It is hypothesized that individuals randomly assigned to receive Readiness and Motivation Therapy (RMT) will have higher readiness and motivation scores and improved eating disorder and psychiatric symptomatology following the intervention than individuals assigned to a no-treatment control condition.
Read the detailed description
Readiness and motivation for change is a significant concern in the treatment of individuals with eating disorders, as evidenced by frequent treatment drop-out, refusal, and relapse. This research examines the efficacy of a 5-session intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa. A manualized treatment protocol of Readiness and Motivation therapy (RMT) has been developed. It is hypothesized that individuals randomly assigned to RMT will have improved readiness and motivation for change as assessed using the Readiness and Motivation Interview (RMI) at post-treatment, 3-month, and one-year follow-up than individuals assigned to a no treatment control condition. If RMT proves to be effective, it could be added to the menu of treatment options, to permit for better tailoring of treatment to client readiness for change.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Being tested
- Readiness and Motivation Therapy
- Keywords
- anorexia nervosa, bulimia nervosa, readiness and motivation
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Readiness and Motivation TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness and Motivation Scores Post-treatment and at 3-month and one-year follow-up
Secondary outcomes (1)
Psychiatric and eating disorder symptom severity Post-treatment and at 3-month and one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2000
- Study completionJun 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Josie Geller, Ph.D., Principal investigator, St. Paul's Hospital, Department of Psychiatry/University of British Columbia, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220662
- Sponsor's protocol ID
- BCM99-0177
- Status last verified
- Jul 2004
- First submitted
- 16 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Readiness and Motivation Therapy in Individuals With Anorexia Nervosa and Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT00220662
- Acronym / sponsor ID
- BCM99-0177
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- anorexia nervosa, bulimia nervosa, readiness and motivation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- Jun 2000
- Study completion
- Jun 2006
- First posted
- 22 Sep 2005 (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 research examines the efficacy of a 5-session individual psychotherapy intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified.
It is hypothesized that individuals randomly assigned to receive Readiness and Motivation Therapy (RMT) will have higher readiness and motivation scores and improved eating disorder and psychiatric symptomatology following the intervention than individuals assigned to a no-treatment control condition.
Detailed description
Readiness and motivation for change is a significant concern in the treatment of individuals with eating disorders, as evidenced by frequent treatment drop-out, refusal, and relapse. This research examines the efficacy of a 5-session intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa. A manualized treatment protocol of Readiness and Motivation therapy (RMT) has been developed. It is hypothesized that individuals randomly assigned to RMT will have improved readiness and motivation for change as assessed using the Readiness and Motivation Interview (RMI) at post-treatment, 3-month, and one-year follow-up than individuals assigned to a no treatment control condition. If RMT proves to be effective, it could be added to the menu of treatment options, to permit for better tailoring of treatment to client readiness for change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- meet DSM-IV diagnostic criteria for anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified
Key exclusion criteria (2 listed)
- acute medical crisis
- acute psychiatric crisis
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 |
|---|---|---|
| Readiness and Motivation Therapy | Behavioural | – |
Primary outcome
Readiness and Motivation Scores Post-treatment and at 3-month and one-year follow-up
1 secondary outcome
Psychiatric and eating disorder symptom severity Post-treatment and at 3-month and one-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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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.
Josie Geller, Ph.D. principal investigator
St. Paul's Hospital, Department of Psychiatry/University of British Columbia, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Readiness and Motivation Therapy in people with Anorexia Nervosa and Bulimia Nervosa, run by St. Paul's Hospital, Canada at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2005. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Readiness and Motivation Scores Post-treatment and at 3-month and one-year 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 22 Sep 2005.