Bipolar DisorderNCT00522613
Recovery Group Pilot
A study testing Recovery Group Project in people with Bipolar Disorder and Schizophrenia, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate a low-cost, joint consumer/counselor-led, health education and support intervention that will foster self-care and recovery among adults with serious mental illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Recovery Group Project
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bipolar disorder or schizophrenia/schizoaffective disorder
- current membership in KPNW
- age 18 or over
Who cannot join
- having a guardian
- psychotic symptoms that interfere with group interactions
- dementia, mental retardation (other than mild) or other organic brain conditions that affect an individual's ability to participate in an interview, a group intervention, or complete questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
The purpose of this study is to develop and evaluate a low-cost, joint consumer/counselor-led, health education and support intervention that will foster self-care and recovery among adults with serious mental illness. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.
Read the detailed description
Recent research suggests that many individuals with serious mental illnesses may recover from these conditions and become fully integrated into their communities. Although improved medications may be most responsible for these developments, self-help groups, social support, and empowerment have been identified as important facilitators of the recovery process. Recovery-oriented, consumer-led approaches are gaining in popularity, but few of these interventions have been evaluated scientifically.
This pilot study proposes to develop and evaluate a recovery-oriented program that centers on the use of a self-help workbook. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.
Objectives:
- To develop group-facilitator materials to complement the self-help workbook.
- To conduct a randomized trial of the intervention with kaiser Permanente Northwest (KPNW) members with bipolar disorder or schizophrenia/schizoaffective disorder, using a delayed control group design and 6- and 12-month post-intervention follow-up.
- To assess participant attendance and satisfaction with the group sessions;
- To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning.
- Conditions
- Bipolar Disorder, Schizophrenia, Schizoaffective Disorder
- Being tested
- Recovery Group Project
- Keywords
- recovery, serious mental illness, bipolar disorder, schizophrenia, schizoaffective disorder
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Group ProjectBehavioural
Recovery Group Workbook \& Group Sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop group-facilitator materials to complement the self-help workbook
Measured: 6 weeks
To conduct a randomized trial of the intervention with KPNW members
Measured: 6 weeks
To assess participant attendance and satisfaction with the group sessions
Measured: 6 weeks
To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startJul 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Portland State University, University of South Florida
- Investigators
- Carla A. Green, PhD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522613
- Sponsor's protocol ID
- NW-05CGREE-01
- Status last verified
- Sep 2006
- First submitted
- 29 Aug 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Group Pilot
- ClinicalTrials.gov ID
- NCT00522613
- Acronym / sponsor ID
- NW-05CGREE-01
- Conditions
- Bipolar Disorder, Schizophrenia, Schizoaffective Disorder
- Keywords
- recovery, serious mental illness, bipolar disorder, schizophrenia, schizoaffective disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Portland State University, University of South Florida
- Study start
- Jul 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Aug 2007 (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 purpose of this study is to develop and evaluate a low-cost, joint consumer/counselor-led, health education and support intervention that will foster self-care and recovery among adults with serious mental illness. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.
Detailed description
Recent research suggests that many individuals with serious mental illnesses may recover from these conditions and become fully integrated into their communities. Although improved medications may be most responsible for these developments, self-help groups, social support, and empowerment have been identified as important facilitators of the recovery process. Recovery-oriented, consumer-led approaches are gaining in popularity, but few of these interventions have been evaluated scientifically.
This pilot study proposes to develop and evaluate a recovery-oriented program that centers on the use of a self-help workbook. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.
Objectives:
- To develop group-facilitator materials to complement the self-help workbook.
- To conduct a randomized trial of the intervention with kaiser Permanente Northwest (KPNW) members with bipolar disorder or schizophrenia/schizoaffective disorder, using a delayed control group design and 6- and 12-month post-intervention follow-up.
- To assess participant attendance and satisfaction with the group sessions;
- To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of bipolar disorder or schizophrenia/schizoaffective disorder
- current membership in KPNW
- age 18 or over
Key exclusion criteria (3 listed)
- having a guardian
- psychotic symptoms that interfere with group interactions
- dementia, mental retardation (other than mild) or other organic brain conditions that affect an individual's ability to participate in an interview, a group intervention, or complete questionnaires
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 |
|---|---|---|
| Recovery Group ProjectRecovery Group Workbook \& Group Sessions | Behavioural | – |
Primary outcome
To develop group-facilitator materials to complement the self-help workbook
Time frame: 6 weeks
To conduct a randomized trial of the intervention with KPNW members
Time frame: 6 weeks
To assess participant attendance and satisfaction with the group sessions
Time frame: 6 weeks
To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning
Time frame: 6 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 4 Feb 2009.
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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.
Carla A. Green, PhD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Group Project in people with Bipolar Disorder and Schizophrenia, run by Kaiser Permanente 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 3 inclusion and 3 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 4 Feb 2009. 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?
To develop group-facilitator materials to complement the self-help workbook (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 4 Feb 2009; AzTrials last refreshed its copy on 2 Nov 2026.