Psychotic DisorderNCT02958007
Peer Support for Exercise in Older Veterans With Psychotic Disorders
A study testing Peer Education on Exercise for Recovery and Enhanced supervised fitness training in people with Psychotic Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- Peer Education on Exercise for Recovery and Enhanced supervised fitness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of a psychotic disorder, meeting criteria established by the VA Serious Mental Illness Treatment Research and Evaluation Center (SMITREC): schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34)
- age 50 or older
- participation in mental health services at the VA Maryland Healthcare System
- sufficient clinical stability to participate as deemed by a mental health treatment provider and/or chart review
- sufficient medical stability as deemed by a medical provider
Who cannot join
- Current participation in a supervised exercise program
- medical conditions which would preclude exercise participation including:
- unstable angina
- proliferative diabetic retinopathy
- oxygen dependence
- frank incontinence
Show all 15Show fewer
- open wounds
- poorly controlled Type 2 diabetes (HbA1c > 9%)
- current treatment for active cancer
- New York Heart Association Stage II-IV heart failure
- dialysis for chronic kidney disease
- myocardial infarction in the previous three months
- problematic substance abuse/dependence
- imminent risk of suicidal or homicidal behavior
- lack of capacity to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing homes. These challenges make it difficult for this group to engage in health behaviors, such as exercise. This is unfortunate, since participation in health-promoting activities is essential for maintaining functional independence with age. This study aims to develop and pilot test a peer coaching intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans in recovery from mental illness, will provide intensive coaching to older Veterans with psychotic disorders to promote their participation in exercise and physical activity. Results from this study will inform us as to whether this intervention is acceptable to Veterans, feasible to implement, and effective in increasing exercise, physical activity, and physical fitness/function.
Read the detailed description
Project was modified to minimize risk of exposure to COVID-19. Sample size was reduced due to loss of time due to pandemic restrictions.
Anticipated Impacts on Veteran's Healthcare: Older Veterans with psychotic disorders face unique barriers to engagement in health-promoting activities, including prototypical features of psychosis (e.g., negative symptoms, medication side effects) and exacerbating features of the aging process (e.g., increased medical comorbidity, declines in musculoskeletal health). It is critical to develop strategies to empower this group to overcome these barriers and engage in health behaviors that can improve their functioning and quality of life. Peer interventions, or interventions delivered by individuals who are similar to a patient population on some characteristic such as age or diagnosis, effectively promote engagement in health behaviors in a range of populations. Despite the promise of peer support and urgent needs of older adults with psychosis, there are no well-specified peer support interventions that promote participation in health behaviors and are tailored to the needs of this group. The present study will yield a well-specified group-based peer coaching intervention, to be delivered by VA Peer Specialists (Veterans in recovery from mental illness), targeted to empower older Veterans with psychosis to overcome barriers, increase exercise/physical activity, and improve functioning.
Project Background: Over the next two decades, Veterans with psychotic disorders (i.e., schizophrenia spectrum disorders and affective psychoses) will age into older adulthood in unprecedented numbers. The challenges of treating this growing population and associated high costs will have profound implications for VHA. Older adults with psychotic disorders exhibit diminished physical and psychosocial functioning and are at increased risk for rapid functional decline and early institutionalization in nursing homes. Participation in structured exercise delays functional disability in older adults; however, older adults with psychosis exhibit low exercise participation. While peer-delivered exercise interventions for older adults promote initiation and maintenance of exercise and physical activity, there are no peer-delivered exercise interventions tailored to the unique needs of older adults with psychosis. The present study aims to fill this critical gap.
Project Objectives: This study will develop and pilot test a well-specified, group-based peer coaching intervention tailored to the unique needs of older Veterans with psychotic disorders: Peer Education on Exercise for Recovery (PEER). PEER will provide intensive coaching from a VA Peer Specialist to promote participation in a supervised fitness training program for older Veterans. To develop the intervention, materials from existing peer-delivered wellness interventions for Veterans with serious mental illness will be tailored for older Veterans with psychosis, through an iterative process synthesizing the extant literature and pilot data, developing draft materials, and obtaining feedback from a multidisciplinary panel of expert mentors/consultants and Peer Specialists/Veteran consumers. A small open trial of PEER will be conducted with 6 older Veterans with psychotic disorders (ages 50 and up); qualitative interviews will explore participants' perceptions of PEER. Finally, a pilot randomized controlled trial (RCT) of PEER will be conducted. Older Veterans with psychotic disorders (ages 50 and up, n=22) will be enrolled in supervised fitness training and randomized to receive group-based peer coaching (the PEER condition) or individual support from non-peer staff (the enhanced supervised fitness training (ESFT) condition). Feasibility of PEER (rates of recruitment, intervention engagement, and peer coach fidelity) will be measured. The impact of PEER versus ESFT on attendance of exercise sessions, levels of physical activity, and physical functioning will be examined. Additionally, the PI will engage in training activities to develop expertise in the functional rehabilitation of older adults with psychosis.
Project Methods: This project will include developing intervention materials for PEER, conducting an open trial of PEER in a small sample, and completing a small RCT. The investigators will monitor acceptability and feasibility; study Veterans' experiences; and measure exercise/physical activity behaviors and functional outcomes.
- Conditions
- Psychotic Disorder
- Being tested
- Peer Education on Exercise for Recovery, Enhanced supervised fitness training
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Education on Exercise for RecoveryBehavioural
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Enhanced supervised fitness trainingBehavioural
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
| Study group | Role | What they receive |
|---|---|---|
| Peer Education on Exercise for Recovery | Experimental | A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity Receives: Behavioral: Peer Education on Exercise for Recovery |
| Enhanced supervised fitness training | Active comparator | A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff Receives: Behavioral: Enhanced supervised fitness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Engagement
Percent of participants randomized to PEER who attend at least three group sessions
Measured: 12 weeks
Intervention Fidelity
Percent of sampled PEER group sessions in which the peer coaches were adequately adherent, as per the PEER Fidelity Measure. This measure includes content items (e.g., "How well did facilitators review the educational topic of the day") and process items (e.g., "How well did facilitators provide positive feedback and reinforcement throughout the class?") Each item is rated as 0 (unacceptable), 1 (acceptable), or 2 (excellent), and then an average score is calculated. Adequate adherence was defined as an average score of 1 or greater and no items rated as unacceptable.
Measured: 12 weeks
Attendance
Attendance- mean number of supervised fitness training sessions attended
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start1 Jun 2018
- Primary completion30 Nov 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anjana Muralidharan, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958007
- Sponsor's protocol ID
- D2339-W
- Other IDs
- 1IK2RX002339-01A1
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2016
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support for Exercise in Older Veterans With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT02958007
- Acronym / sponsor ID
- D2339-W
- Conditions
- Psychotic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 25 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing homes. These challenges make it difficult for this group to engage in health behaviors, such as exercise. This is unfortunate, since participation in health-promoting activities is essential for maintaining functional independence with age. This study aims to develop and pilot test a peer coaching intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans in recovery from mental illness, will provide intensive coaching to older Veterans with psychotic disorders to promote their participation in exercise and physical activity. Results from this study will inform us as to whether this intervention is acceptable to Veterans, feasible to implement, and effective in increasing exercise, physical activity, and physical fitness/function.
Detailed description
Project was modified to minimize risk of exposure to COVID-19. Sample size was reduced due to loss of time due to pandemic restrictions.
Anticipated Impacts on Veteran's Healthcare: Older Veterans with psychotic disorders face unique barriers to engagement in health-promoting activities, including prototypical features of psychosis (e.g., negative symptoms, medication side effects) and exacerbating features of the aging process (e.g., increased medical comorbidity, declines in musculoskeletal health). It is critical to develop strategies to empower this group to overcome these barriers and engage in health behaviors that can improve their functioning and quality of life. Peer interventions, or interventions delivered by individuals who are similar to a patient population on some characteristic such as age or diagnosis, effectively promote engagement in health behaviors in a range of populations. Despite the promise of peer support and urgent needs of older adults with psychosis, there are no well-specified peer support interventions that promote participation in health behaviors and are tailored to the needs of this group. The present study will yield a well-specified group-based peer coaching intervention, to be delivered by VA Peer Specialists (Veterans in recovery from mental illness), targeted to empower older Veterans with psychosis to overcome barriers, increase exercise/physical activity, and improve functioning.
Project Background: Over the next two decades, Veterans with psychotic disorders (i.e., schizophrenia spectrum disorders and affective psychoses) will age into older adulthood in unprecedented numbers. The challenges of treating this growing population and associated high costs will have profound implications for VHA. Older adults with psychotic disorders exhibit diminished physical and psychosocial functioning and are at increased risk for rapid functional decline and early institutionalization in nursing homes. Participation in structured exercise delays functional disability in older adults; however, older adults with psychosis exhibit low exercise participation. While peer-delivered exercise interventions for older adults promote initiation and maintenance of exercise and physical activity, there are no peer-delivered exercise interventions tailored to the unique needs of older adults with psychosis. The present study aims to fill this critical gap.
Project Objectives: This study will develop and pilot test a well-specified, group-based peer coaching intervention tailored to the unique needs of older Veterans with psychotic disorders: Peer Education on Exercise for Recovery (PEER). PEER will provide intensive coaching from a VA Peer Specialist to promote participation in a supervised fitness training program for older Veterans. To develop the intervention, materials from existing peer-delivered wellness interventions for Veterans with serious mental illness will be tailored for older Veterans with psychosis, through an iterative process synthesizing the extant literature and pilot data, developing draft materials, and obtaining feedback from a multidisciplinary panel of expert mentors/consultants and Peer Specialists/Veteran consumers. A small open trial of PEER will be conducted with 6 older Veterans with psychotic disorders (ages 50 and up); qualitative interviews will explore participants' perceptions of PEER. Finally, a pilot randomized controlled trial (RCT) of PEER will be conducted. Older Veterans with psychotic disorders (ages 50 and up, n=22) will be enrolled in supervised fitness training and randomized to receive group-based peer coaching (the PEER condition) or individual support from non-peer staff (the enhanced supervised fitness training (ESFT) condition). Feasibility of PEER (rates of recruitment, intervention engagement, and peer coach fidelity) will be measured. The impact of PEER versus ESFT on attendance of exercise sessions, levels of physical activity, and physical functioning will be examined. Additionally, the PI will engage in training activities to develop expertise in the functional rehabilitation of older adults with psychosis.
Project Methods: This project will include developing intervention materials for PEER, conducting an open trial of PEER in a small sample, and completing a small RCT. The investigators will monitor acceptability and feasibility; study Veterans' experiences; and measure exercise/physical activity behaviors and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Education on Exercise for Recovery | Experimental | Behavioral: Peer Education on Exercise for RecoveryA 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity |
| Enhanced supervised fitness training | Active comparator | Behavioral: Enhanced supervised fitness trainingA 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current diagnosis of a psychotic disorder, meeting criteria established by the VA Serious Mental Illness Treatment Research and Evaluation Center (SMITREC): schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34)
- age 50 or older
- participation in mental health services at the VA Maryland Healthcare System
- sufficient clinical stability to participate as deemed by a mental health treatment provider and/or chart review
- sufficient medical stability as deemed by a medical provider
Key exclusion criteria (15 listed)
- Current participation in a supervised exercise program
- medical conditions which would preclude exercise participation including:
- problematic substance abuse/dependence
- imminent risk of suicidal or homicidal behavior
- lack of capacity to consent
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 |
|---|---|---|
| Peer Education on Exercise for RecoveryA 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity | Behavioural | Peer Education on Exercise for Recovery |
| Enhanced supervised fitness trainingA 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff | Behavioural | Enhanced supervised fitness training |
Primary outcome
Intervention Engagement
Time frame: 12 weeks
Percent of participants randomized to PEER who attend at least three group sessions
Intervention Fidelity
Time frame: 12 weeks
Percent of sampled PEER group sessions in which the peer coaches were adequately adherent, as per the PEER Fidelity Measure. This measure includes content items (e.g., "How well did facilitators review the educational topic of the day") and process items (e.g., "How well did facilitators provide positive feedback and reinforcement throughout the class?") Each item is rated as 0 (unacceptable), 1 (acceptable), or 2 (excellent), and then an average score is calculated. Adequate adherence was defined as an average score of 1 or greater and no items rated as unacceptable.
Attendance
Time frame: 12 weeks
Attendance- mean number of supervised fitness training sessions attended
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anjana Muralidharan, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Education on Exercise for Recovery and Enhanced supervised fitness training in people with Psychotic Disorder, run by VA Office of Research and Development 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 5 inclusion and 15 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 25 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Engagement (time frame: 12 weeks). The study lists 3 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 25 Sep 2023.