SchizophreniaNCT00458094
Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses
A study testing Physical activity intervention with peer support (PA+PS) and Physical activity intervention without peer support (PA) in people with Schizophrenia and Depression, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Depression, Bipolar Disorder
- What is being tested?
- Physical activity intervention with peer support (PA+PS) and Physical activity intervention without peer support (PA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2009
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient at the Johns Hopkins Community Psychiatry program
- Plans to remain in Baltimore for 8 months after study entry
- If currently breastfeeding, has received approval from a physician to participate in the study
Who cannot join
- Any condition that would make weight loss medically inadvisable
- Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry
- Liver failure
- History of anorexia nervosa
- Pregnant or planning to become pregnant during the study
- Inability to walk or participate in an exercise class
- Consumes more than 14 alcoholic drinks per week
- Symptoms of angina or a cardiovascular event within 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activating Consumers to Exercise in Community Psychiatry Through Peer Support
This study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.
Read the detailed description
People with serious mental illnesses (SMIs) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. Schizophrenia, major depression, and bipolar disorder are considered SMIs. Severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as SMIs, as well. The rate of obesity among people with SMIs is higher than that of people without mental illnesses. This disparity may be due to the negative symptoms that people with SMIs experience, such as vulnerability to stress, extreme dependency, and lack of motivation. This study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with SMIs in an urban community psychiatry program. The intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with SMIs.
Participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (PA+PS) or a physical activity intervention without peer support (PA). Participants in the PA+PS group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. Participants in the PA group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. All outcomes will be assessed at a follow-up visit at the end of the intervention.
- Conditions
- Schizophrenia, Depression, Bipolar Disorder, Anxiety Disorders, Cognitive Disorders, Personality Disorders
- Being tested
- Physical activity intervention with peer support (PA+PS), Physical activity intervention without peer support (PA)
- Keywords
- Exercise, Mental Illness, Community Psychiatry, Peer Support, Mental Disorders
- Medical subject headings
- Schizophrenia, Depression, Bipolar Disorder, Anxiety Disorders, Cognitive Dysfunction, Personality Disorders, Motor Activity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity intervention with peer support (PA+PS)Behavioural
Participants in the PA+PS group will have three exercise sessions each week for 4 months, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions.
Physical activity intervention without peer support (PA)Behavioural
Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive the peer-supported physical activity intervention Receives: Behavioral: Physical activity intervention with peer support (PA+PS) |
| 2 | Active comparator | Participants will receive physical activity without peer support Receives: Behavioral: Physical activity intervention without peer support (PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Measured: Measured at Month 4
Secondary outcomes (8)
Weight
Measured: Measured at Month 4
Waist circumference
Measured: Measured at Month 4
Physical activity
Measured: Measured at Month 4
Health status
Measured: Measured at Month 4
Center for Epidemiology Depression Scale
Measured: Measured at Month 4
Exercise-related self-efficacy
Measured: Measured at Month 4
General perceived efficacy
Measured: Measured at Month 4
Participation
Measured: Measured at Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail L. Daumit, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458094
- Sponsor's protocol ID
- R34MH078613
- Other IDs
- R34MH078613, DAHBR 96-BHB
- Status last verified
- Dec 2017
- First submitted
- 5 Apr 2007
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Consumers to Exercise in Community Psychiatry Through Peer Support
- ClinicalTrials.gov ID
- NCT00458094
- Acronym / sponsor ID
- R34MH078613
- Conditions
- Schizophrenia, Depression, Bipolar Disorder, Anxiety Disorders, Cognitive Disorders, Personality Disorders
- Keywords
- Exercise, Mental Illness, Community Psychiatry, Peer Support, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Apr 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.
This study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.
Detailed description
People with serious mental illnesses (SMIs) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. Schizophrenia, major depression, and bipolar disorder are considered SMIs. Severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as SMIs, as well. The rate of obesity among people with SMIs is higher than that of people without mental illnesses. This disparity may be due to the negative symptoms that people with SMIs experience, such as vulnerability to stress, extreme dependency, and lack of motivation. This study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with SMIs in an urban community psychiatry program. The intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with SMIs.
Participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (PA+PS) or a physical activity intervention without peer support (PA). Participants in the PA+PS group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. Participants in the PA group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. All outcomes will be assessed at a follow-up visit at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Physical activity intervention with peer support (PA+PS)Participants will receive the peer-supported physical activity intervention |
| 2 | Active comparator | Behavioral: Physical activity intervention without peer support (PA)Participants will receive physical activity without peer support |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient at the Johns Hopkins Community Psychiatry program
- Plans to remain in Baltimore for 8 months after study entry
- If currently breastfeeding, has received approval from a physician to participate in the study
Key exclusion criteria (8 listed)
- Any condition that would make weight loss medically inadvisable
- Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry
- Liver failure
- History of anorexia nervosa
- Pregnant or planning to become pregnant during the study
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 |
|---|---|---|
| Physical activity intervention with peer support (PA+PS)Participants in the PA+PS group will have three exercise sessions each week for 4 months, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. | Behavioural | 1 |
| Physical activity intervention without peer support (PA)Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator. | Behavioural | 2 |
Primary outcome
Cardiorespiratory fitness
Time frame: Measured at Month 4
8 secondary outcomes
Weight
Time frame: Measured at Month 4
Waist circumference
Time frame: Measured at Month 4
Physical activity
Time frame: Measured at Month 4
Health status
Time frame: Measured at Month 4
Center for Epidemiology Depression Scale
Time frame: Measured at Month 4
Exercise-related self-efficacy
Time frame: Measured at Month 4
General perceived efficacy
Time frame: Measured at Month 4
Participation
Time frame: Measured at Month 4
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 6 Dec 2017.
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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.
Gail L. Daumit, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention with peer support (PA+PS) and Physical activity intervention without peer support (PA) in people with Schizophrenia and Depression, run by Johns Hopkins University 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 8 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 6 Dec 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?
Cardiorespiratory fitness (time frame: Measured at Month 4). 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 6 Dec 2017.