Serious Mental IllnessNCT06370767
Peer Facilitated Waitlist Controlled Transportation Study
A study testing Bike-Share Travel Training and Public Transportation Travel Training in people with Serious Mental Illness, run by Temple University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Serious Mental Illness
- What is being tested?
- Bike-Share Travel Training and Public Transportation Travel Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are between the ages of 18 and 65
- are diagnosed with a SMI (confirmed via the MINI)
- score at least an 8 on a travel skills assessment
- indicates that they can ride a bicycle
- have expressed interest in using a bikeshare and public transportation
- are able to provide informed consent
Who cannot join
- score less than 8 on a travel skills assessment
- express no interest in independent transportation
- are non-English speaking individuals
- are unable to provide consent
- are living in a setting where mobility and participation is restricted
- have a limiting physical condition that would prevent their ability to ride a bicycle independently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gretchen Snethen, PhD contact
United States1 site, 1 recruiting
- Recruiting
Pathways To Housing PA
Philadelphia, Pennsylvania, 19141
About this study
Official title: Enhancing Community Mobility in Individuals With Serious Mental Illnesses Through Peer-Facilitated Travel Training: A Two-armed Waitlist Controlled Trial
The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:
- Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.
- Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.
- Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.
Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews.
Read the detailed description
This project proposes using a two-armed, waitlist controlled trial to test the effectiveness of peer-facilitated travel interventions and their ability to enhance community mobility and increase feelings of self-efficacy in individuals with serious mental illness (SMI). The first intervention arm is an 8-week bikeshare intervention, which consists of individual trainings on using a bike sharing program; the second intervention arm is an 8-week public transportation intervention, which consists of individual trainings for using public transportation in the Philadelphia area. The investigators seek to enroll a total of 180 individuals from community mental health agencies in the Philadelphia area and expect recruitment to take 3 years. Eligible participants will be individuals who meet criteria indicating that they have an SMI, are between the ages of 18-65, and are both willing and able to learn to use public transportation and ride a bicycle. Data will be collected via face-to-face or web-based video call interviews at 3 time points: baseline, 2-months post-baseline, and 4-months post-baseline. Participants will also complete short surveys about their travel behaviors over the phone in the seven days after each interview. There will also be a subsample of participants who will provide additional GPS data.
- Conditions
- Serious Mental Illness
- Being tested
- Bike-Share Travel Training, Public Transportation Travel Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bike-Share Travel TrainingBehavioural
Half of the participants not assigned to the waitlist will begin the bike-share intervention arm immediately after the baseline research interview. The bike-share arm will last for 8 weeks and be delivered by a community peer specialist. Half of the participants assigned to the waitlist will begin the bike-share intervention arm after an 8-week waiting period.
Public Transportation Travel TrainingBehavioural
Half of the participants not assigned to the waitlist or bike-share arm will begin the public transportation intervention arm immediately after the baseline research interview. The public transportation arm will last for 8 weeks and be delivered by a community peer specialist. Half of the participants assigned to the waitlist will begin the public transportation intervention arm after an 8-week waiting period.
| Study group | Role | What they receive |
|---|---|---|
| Bike-Share | Experimental | Participants in this arm will participate in an 8-week bikeshare training program, using Indego, the bike sharing service in Philadelphia. The first sessions will be aimed at increasing knowledge of the bike share program and the procedures for utilizing it successfully. Then participants will meet with a peer support specialist, who will help facilitate individualized route planning and independent ride support. Peer support specialists will use motivational interviewing during these individual sessions in order to help participants identify personally meaningful motivations for participation and to enhance their sense of self-efficacy. Receives: Behavioral: Bike-Share Travel Training |
| Public Transportation | Experimental | An established travel-training program developed for individuals with disabilities, including those with SMI, serves as the curriculum for the public transportation intervention arm. Participants will use SEPTA, the public transportation provider in Philadelphia and surrounding areas. We will offer an 8-week intervention which will include instruction on foundational skills needed to travel on public transportation and 1-on-1 direct training in using public transportation. Participants will meet twice weekly for direct instruction and role-playing sessions to cover the core components and the latter weeks of intervention will be focused on individual travel training instruction provided by the peer support interventionists, with participants and peer support interventionists meeting for two travel trips each week. Receives: Behavioral: Public Transportation Travel Training |
| Waitlist Control | No intervention | Half of the participants in either arm (bike-share or public transportation) will be randomly assigned to either begin the intervention immediately, or be placed on a waitlist, serving as a control arm. The waitlist will be 8 weeks long, the same timeline as the intervention. After the eighth week, participants assigned to the waitlist will then begin the intervention for the next 8 weeks. Participants assigned to starting the intervention immediately will then be placed on the waitlist for the second-8 weeks of the total study enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temple University Community Participation Measure
Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
LASA Sedentary Behaviors Questionnaire
This survey measures the time spent doing various activities that are usually completed while sitting down. For a 24-hour period on both weekdays and weekends, the reporting asks "How much time do you spend (from when you wake up until you go to bed) doing the following?" For this research, it will be used to measure changes in sedentary behaviors over time.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Transportation Appraisal Scale
This measure assesses participants' ability to use public transportation and travel around their community. Items are asked on a 4-point scale, asking how much help is needed with various travel tasks, including reading schedules to plan a trip and knowing how to pay for transportation. For this research, it will be used to measure changes in transportation self-efficacy over time.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Indego Skills Survey
This is an open-ended questionnaire to assess participants' skills with navigating the Indeo bike-sharing program in Philadelphia. Researchers give points to participants' responses on questions pertaining to the access, payment, and return of the bikes. For this research, it will be used to measure Indego skills at the time of the interview.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
SEPTA Skills Survey
Similar to the Indego Skills Survey, this is an open-ended questionnaire to assess participants' skills with navigating Philadelphia's public transit system, SEPTA. Researchers give points to participants' responses on questions pertaining to the access, payment, and choosing the correct bus or subway stop. For this research, it will be used to measure SEPTA skills at the time of the interview
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified)
This role-play measurement was designed for individuals with mental health challenges to assess participant's real-word abilities. The Transportation subscale uses a pitcutre of a bus schedule and asks the participant to correctly identify the departure, destination, and costs of rides. For this research, it will be used to measure SEPTA and bikeshare planning skills.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
National Household Travel Survey
This is a daily, self-report measure that captures the amount and types of trips a participant takes in one day. The log will be administered over the phone by a research assistant, asking how many trips were taken, the type of trip (medical appointment, work, social outing, etc), the mode of transportation (personal vehicle, public transit, bike, walk, etc) and the general location of the trip.
Measured: Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews.
GPS
A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled.
A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled.
A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled.
A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled.
Measured: GPS data collection will last for 14 days after initial baseline interviews and another 14 days after completion of the 8-week intervention.
Secondary outcomes (7)
Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version)
This scale is designed to measure self-stigma among persons with psychiatric disorders. The brief measure takes the strongest items from each of the subscales of the full measure. The subscales and item examples include: Alienation (e.g. "Having a mental illness has spoiled my life"), Stereotype Endorsement (e.g., "Mentally ill people tend to be violent"), Discrimination Experience (e.g., "People discriminate against me because I have a mental illness"), Social Withdrawal (e.g., " I don't talk about myself as much because I don't want to burden others with my mental illness"), and Stigma Resistance (e.g., "I can have a good, fulfilling life, despite my mental illness") that is scored on a 4-point Likert scale. For this research, it will be used to measure changes in internalized stigma over time.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
University of California, Los Angeles, Loneliness Scale
These 3 questions are only being given to people who report having a mental illness. The questions related to how often people feel socially isolated or lonely. Response options range from 1) hardly ever, 2) some of the time, and 3) often. Responses (3) indicate increased loneliness and more "hardly ever" responses indicate less loneliness.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Pearlin Mastery Scale (Coping)
This is 7-item mastery scale to assess participants' feeling of control over their lives. Items are asked on a 4-point Likert scale and include statement like "I have little control over the things that happen to me" and "What happens to me in the future mostly depends on me." For this research, it will be used to measure changes in participants' abilities to cope with symptoms over time.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
SF- 36 v2
This measure asks about health status and physical capability of daily activities. Participants are asked to rank their health over the last week, including experiences of pain, sickness, tiredness, and physical activities like walking or carrying. For this research, it will be used to measure self-perceived physical health.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
The PERMA - Profiler Measure
The PERMA Profiler is based on the five pillars of wellbeing: positive emotion, engagement, relationships, meaning, accomplishment). Items are asked on a 10-pint scale and include items such as "How often do you schieve the important goals you have set for yourself?", "How lonely do you feel in your daily life?", and "To what extent do you feel loved?". For this research, it will be used to measure perceived quality of life.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Recovery Assessment Scale (RAS)
Three subscale from the RAS will be used: 1) reliance on others, 2) confidence and hope, and 3) willingness to ask for help. Responses range from strongly disagree (1) to strongly agree (5). Scores can range from 16-80 with higher scores indicating greater recovery, reliance on others, confidence, and willingness to ask for help.
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Group Identification Scale (GIS)
This scale measures intergroup relations and self-concept of group identification. Participants will be asked on a 7-point Likert scale how the agree or disagree with statements comparing them to other SEPTA and bikeshare riders. For this research, it will be used to measure participants' feeling of belonging in the groups of public transportation users, bikeshare, and their local community
Measured: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start12 Sep 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either start the intervention program immediately, or be placed on an 8-week waitlist. Once randomized, the participant will again be randomized into a treatment condition: 1) peer-mediated bikeshare training intervention; or 2) peer-mediated public travel training intervention. 20 participants from each condition who have not opted out of being in the GPS subsample will be randomly assigned to be invited to a GPS subgroup.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370767
- Sponsor's protocol ID
- 25634
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with other researchers, research institutions, or research databases for use in other studies. Per funder regulations, at the completion of the study all deidentified data will be transferred to ICPSR (https://www.icpsr.umich.edu/icpsrweb/) so that data can be used by others for additional analysis. Participants may request to have their data destroyed, but are notified at consent that de-identified data that has already been shared cannot be taken back or destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Community Mobility in Individuals With Serious Mental Illnesses Through Peer-Facilitated Travel Training: A Two-armed Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT06370767
- Acronym / sponsor ID
- 25634
- Conditions
- Serious Mental Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- 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 goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:
- Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.
- Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.
- Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.
Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews.
Detailed description
This project proposes using a two-armed, waitlist controlled trial to test the effectiveness of peer-facilitated travel interventions and their ability to enhance community mobility and increase feelings of self-efficacy in individuals with serious mental illness (SMI). The first intervention arm is an 8-week bikeshare intervention, which consists of individual trainings on using a bike sharing program; the second intervention arm is an 8-week public transportation intervention, which consists of individual trainings for using public transportation in the Philadelphia area. The investigators seek to enroll a total of 180 individuals from community mental health agencies in the Philadelphia area and expect recruitment to take 3 years. Eligible participants will be individuals who meet criteria indicating that they have an SMI, are between the ages of 18-65, and are both willing and able to learn to use public transportation and ride a bicycle. Data will be collected via face-to-face or web-based video call interviews at 3 time points: baseline, 2-months post-baseline, and 4-months post-baseline. Participants will also complete short surveys about their travel behaviors over the phone in the seven days after each interview. There will also be a subsample of participants who will provide additional GPS data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to either start the intervention program immediately, or be placed on an 8-week waitlist. Once randomized, the participant will again be randomized into a treatment condition: 1) peer-mediated bikeshare training intervention; or 2) peer-mediated public travel training intervention. 20 participants from each condition who have not opted out of being in the GPS subsample will be randomly assigned to be invited to a GPS subgroup.
| Arm | Type | Receives |
|---|---|---|
| Bike-Share | Experimental | Behavioral: Bike-Share Travel TrainingParticipants in this arm will participate in an 8-week bikeshare training program, using Indego, the bike sharing service in Philadelphia. The first sessions will be aimed at increasing knowledge of the bike share program and the procedures for utilizing it successfully. Then participants will meet with a peer support specialist, who will help facilitate individualized route planning and independent ride support. Peer support specialists will use motivational interviewing during these individual sessions in order to help participants identify personally meaningful motivations for participation and to enhance their sense of self-efficacy. |
| Public Transportation | Experimental | Behavioral: Public Transportation Travel TrainingAn established travel-training program developed for individuals with disabilities, including those with SMI, serves as the curriculum for the public transportation intervention arm. Participants will use SEPTA, the public transportation provider in Philadelphia and surrounding areas. We will offer an 8-week intervention which will include instruction on foundational skills needed to travel on public transportation and 1-on-1 direct training in using public transportation. Participants will meet twice weekly for direct instruction and role-playing sessions to cover the core components and the latter weeks of intervention will be focused on individual travel training instruction provided by the peer support interventionists, with participants and peer support interventionists meeting for two travel trips each week. |
| Waitlist Control | No intervention | –Half of the participants in either arm (bike-share or public transportation) will be randomly assigned to either begin the intervention immediately, or be placed on a waitlist, serving as a control arm. The waitlist will be 8 weeks long, the same timeline as the intervention. After the eighth week, participants assigned to the waitlist will then begin the intervention for the next 8 weeks. Participants assigned to starting the intervention immediately will then be placed on the waitlist for the second-8 weeks of the total study enrollment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are between the ages of 18 and 65
- are diagnosed with a SMI (confirmed via the MINI)
- score at least an 8 on a travel skills assessment
- indicates that they can ride a bicycle
- have expressed interest in using a bikeshare and public transportation
Key exclusion criteria (6 listed)
- score less than 8 on a travel skills assessment
- express no interest in independent transportation
- are non-English speaking individuals
- are unable to provide consent
- are living in a setting where mobility and participation is restricted
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 |
|---|---|---|
| Bike-Share Travel TrainingHalf of the participants not assigned to the waitlist will begin the bike-share intervention arm immediately after the baseline research interview. The bike-share arm will last for 8 weeks and be delivered by a community peer specialist. Half of the participants assigned to the waitlist will begin the bike-share intervention arm after an 8-week waiting period. | Behavioural | Bike-Share |
| Public Transportation Travel TrainingHalf of the participants not assigned to the waitlist or bike-share arm will begin the public transportation intervention arm immediately after the baseline research interview. The public transportation arm will last for 8 weeks and be delivered by a community peer specialist. Half of the participants assigned to the waitlist will begin the public transportation intervention arm after an 8-week waiting period. | Behavioural | Public Transportation |
Primary outcome
Temple University Community Participation Measure
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.
LASA Sedentary Behaviors Questionnaire
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This survey measures the time spent doing various activities that are usually completed while sitting down. For a 24-hour period on both weekdays and weekends, the reporting asks "How much time do you spend (from when you wake up until you go to bed) doing the following?" For this research, it will be used to measure changes in sedentary behaviors over time.
Transportation Appraisal Scale
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This measure assesses participants' ability to use public transportation and travel around their community. Items are asked on a 4-point scale, asking how much help is needed with various travel tasks, including reading schedules to plan a trip and knowing how to pay for transportation. For this research, it will be used to measure changes in transportation self-efficacy over time.
Indego Skills Survey
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This is an open-ended questionnaire to assess participants' skills with navigating the Indeo bike-sharing program in Philadelphia. Researchers give points to participants' responses on questions pertaining to the access, payment, and return of the bikes. For this research, it will be used to measure Indego skills at the time of the interview.
SEPTA Skills Survey
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Similar to the Indego Skills Survey, this is an open-ended questionnaire to assess participants' skills with navigating Philadelphia's public transit system, SEPTA. Researchers give points to participants' responses on questions pertaining to the access, payment, and choosing the correct bus or subway stop. For this research, it will be used to measure SEPTA skills at the time of the interview
University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified)
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
This role-play measurement was designed for individuals with mental health challenges to assess participant's real-word abilities. The Transportation subscale uses a pitcutre of a bus schedule and asks the participant to correctly identify the departure, destination, and costs of rides. For this research, it will be used to measure SEPTA and bikeshare planning skills.
National Household Travel Survey
Time frame: Administered daily for 7 days after baseline, 2-month, and 4-month follow-up interviews.
This is a daily, self-report measure that captures the amount and types of trips a participant takes in one day. The log will be administered over the phone by a research assistant, asking how many trips were taken, the type of trip (medical appointment, work, social outing, etc), the mode of transportation (personal vehicle, public transit, bike, walk, etc) and the general location of the trip.
GPS
Time frame: GPS data collection will last for 14 days after initial baseline interviews and another 14 days after completion of the 8-week intervention.
A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled. A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled. A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled. A subsample of participants will carry a cellphone that will track their movements in the community using a GPS app. Outcome measures include: 1) number of unique destination, 2) total number of destinations, and 3) total distance traveled.
7 secondary outcomes
Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version)
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
University of California, Los Angeles, Loneliness Scale
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Pearlin Mastery Scale (Coping)
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
SF- 36 v2
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
The PERMA - Profiler Measure
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Recovery Assessment Scale (RAS)
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Group Identification Scale (GIS)
Time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other researchers, research institutions, or research databases for use in other studies. Per funder regulations, at the completion of the study all deidentified data will be transferred to ICPSR (https://www.icpsr.umich.edu/icpsrweb/) so that data can be used by others for additional analysis. Participants may request to have their data destroyed, but are notified at consent that de-identified data that has already been shared cannot be taken back or destroyed.
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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.
Gretchen Snethen, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bike-Share Travel Training and Public Transportation Travel Training in people with Serious Mental Illness, run by Temple 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 6 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: looking for participants now, as of the sponsor's last update on 1 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gillian A MacDonald, BA ((267) 225-0218, gillian.macdonald@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temple University Community Participation Measure (time frame: Asked at baseline, 2-month, and 4-month follow-ups interviews.). The study lists 8 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 1 Nov 2024.