SchizophreniaNCT04481737
Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery
A study testing Peer-delivered and Technology Support Integrated Illness Management and Recovery and Peer support in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Adults with serious mental illness (SMI) are disproportionately affected by medical comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to the general population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Recurrent
- What is being tested?
- Peer-delivered and Technology Support Integrated Illness Management and Recovery and Peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Jan 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Consumer Inclusion Criteria
Consumer eligibility includes the following:
- (1) participants will be adults age 18 or older who have a chart DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, persistent major depressive disorder (diagnosis will be verified using the Mini-International Neuropsychiatric Interview);
- (2) have been enrolled in treatment for at least 3 months;
- (3) a chart diagnosis of a medical diagnosis of cardiovascular disease, obesity, diabetes, or chronic obstructive pulmonary disease;
- (4) speak and read English; and
- (5) voluntary informed consent for participation in the study by the participant.
Consumer Exclusion Criteria
Consumer participants will be excluded based on the following criteria:
- (1) chart diagnosis of dementia or documented cognitive impairment as indicated by the Mini Mental State Examination score <24;
- (2) major visual, hearing, or motor impairment (measured by potential participants' ability to use a smartphone);
- (3) currently residing in a nursing home;
- (4) terminal illness expected to result of death of participant within one year; or
- (5) consumers with two or more emergency room or hospitalizations in the last 6 months or as determined by the clinical team to be psychiatrically or medically unstable;
Peer Inclusion Criteria
Peer eligibility includes the following:
- (1) Massachusetts certified peer specialist (i.e., to qualify to be a Massachusetts certified peer specialist a person must self-report any mental health diagnosis, be in active treatment, and complete an 80 hour training that includes classes, small group activities, and homework on fundamentals of peer support, cross-cultural partnering, and human experience language. All certified peer specialists must pass a written examination);
- (2) a clinical history of improved psychiatric and medical self-management in the past 6 months;
- (3) speak and read English;
- (4) willing to use technology to deliver an intervention;
- (5) must provide voluntary informed consent for participation in the study; and
- (6) have worked as a certified peer specialist with people with SMI for 1+ years.
Peer Exclusion Criteria
Peer participants will be excluded based on the following criteria:
- (1) chart diagnosis of dementia or documented cognitive impairment as indicated by the Mini Mental State Examination score <24;
- (2) major visual, hearing, or motor impairment (measured by potential participants' ability to use a tablet); and
- (3) certified peer specialists with two or more emergency room or hospitalizations in the last 6 months or as determined by the clinical team to be psychiatrically or medically unstable.
Trial locations and contacts
1 site in 1 country.
About this study
Adults with serious mental illness (SMI) are disproportionately affected by medical comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to the general population. These high rates of morbidity and early mortality are associated with inadequately managed medical and psychiatric illnesses. A recent systematic review found nine effective self-management interventions that address medical and psychiatric illnesses in adults with SMI. However, there has been limited adoption of these interventions due to both provider and consumer-based factors. Provider-based barriers consist of the lack of an adequate workforce with the capacity, time, and knowledge of effective approaches to self-management support for adults with SMI and chronic health conditions. Consumer-based barriers associated with limited participation in self-management programs include lack of access, engagement, and ongoing community-based support for persons with SMI. Peer support specialists have the potential to address these barriers as they comprise one of the fastest growing sectors of the mental health workforce, have "lived experience" in self-management practices, and offer access to support in the community. However, challenges need to be resolved for peers to be effective providers of evidence-based interventions. For example, peers are frequently trained to provide "peer support" described as "giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful". Peer support has been associated with increased sense of control, ability to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not adhere to evidence-based practices for psychiatric and medical self-management and does not follow protocols that ensure fidelity and systematically monitor outcomes. The investigators hypothesize that mobile technology has the potential to overcome these limitations of peer support by providing real-time guidance in fidelity adherent delivery of a peer-delivered, technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator will build the necessary expertise to pursue a career developing and testing novel approaches to peer-delivered evidence-based self-management interventions. Training will include: development of peer-delivered interventions; development and design of mobile health-supported interventions; and intervention clinical trials research. Concurrently, this study includes refinement of the intervention protocol with input from peers and consumers and conducting a pilot study evaluating the feasibility and potential effectiveness of PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic health conditions. Outcomes include feasibility, medical and psychiatric self-management skills, functional ability, and mortality risk factors and examine self-efficacy and social support as mechanisms on outcomes.
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Recurrent, Obesity, Cardiovascular Diseases, Diabetes
- Being tested
- Peer-delivered and Technology Support Integrated Illness Management and Recovery, Peer support
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Recurrence, Obesity, Cardiovascular Diseases, Diabetes Mellitus, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-delivered and Technology Support Integrated Illness Management and RecoveryBehavioural
PDTA-IIMR is delivered by a peer support specialist with the use of guided IIMR eModules and a smartphone application designed to complement in-person eModule sessions. The eModules are designed to be reviewed with a peer support specialist and consumer during one-hour, weekly, telephonic sessions in a community setting. Each eModule includes videos and experiential learning tasks on psychoeducation and coping skills training.
Peer supportBehavioural
Peer support is a non-manualized form of social support, frequently coupled with instrumental support, that is mutually offered or provided by persons having a mental health condition to others sharing a similar mental health condition to bring about a desired social or personal change. Peer support specialists are provided with 1-hour of supervision each week
| Study group | Role | What they receive |
|---|---|---|
| PDTA-IIMR | Experimental | Not described Receives: Behavioral: Peer-delivered and Technology Support Integrated Illness Management and Recovery |
| Peer support | Active comparator | Not described Receives: Behavioral: Peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of study drop-outs, attendance, and adherence from baseline to 3-months
Review case notes written by peer support specialists to examine count data on attrition, attendance, and patient adherence.
Measured: Baseline and 3-months
Change in average fidelity scores
Peer Support specialists will independently rate themselves after each session using the PDTA-IIMR fidelity scale. The standards used for establishing the items and ratings were determined by expert sources and empirical research.
Measured: Baseline and 3-months
Secondary outcomes (8)
Change from baseline mortality risk index to 3-months and 6-month follow-up
Avoidable Mortality Risk Index includes an examination of modifiable risk factors include: smoking; high blood pressure; excess body weight; high blood glucose; high cholesterol; high alcohol intake; low physical activity; poor diet.
Measured: Baseline, 3-months, and 6-months
Change from baseline self efficacy to 3-months and 6-month follow-up
Self-Efficacy for Managing Chronic Disease. Self-Efficacy for Managing Chronic Disease is a six-item scale that assesses domains of self-efficacy: symptom control, role function, emotional functioning, and communicating with physicians. Higher scores indicate greater self-efficacy.
Measured: Baseline, 3-months, and 6-months
Change from baseline social support to 3-months and 6-month follow-up
Medical Outcomes Study Social Support Survey. Medical Outcomes Study Social Support is a 19-item scale that assesses domains of social support: emotional/informational, tangible, affection, and positive social interaction. Higher scores indicate higher levels of social support.
Measured: Baseline, 3-months, and 6-months
Change from baseline mental health self-management skills to 3-months and 6-month follow-up
Illness Management and Recovery Scale. The Illness Management and Recovery Scale is a valid, reliable 15-item scale that assesses domains of illness management. Each item addresses psychiatric illness, management, and recovery. Higher scores equate to higher ability to manage psychiatric conditions.
Measured: Baseline, 3-months, and 6-months
Change from baseline medical self-management skills to 3-months and 6-month follow-up
Self-Rated Abilities for Health Practices Scale.The Self-Rated Abilities for Health Practices Scale is a 28-item scale that assesses confidence to execute health practices that has shown reliability and validity with adults with disabilities. This scale includes four subscales: exercise, nutrition, responsible health practice, and psychological well-being. Higher scores indicate higher levels of self-efficacy.
Measured: Baseline, 3-months, and 6-months
Change from baseline functional ability to 3-months and 6-month follow-up
PROMIS Global Health. The PROMIS Global Health includes 10-items that measures five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). The measure is agnostic, rather than disease-specific, and commonly used to show an individuals' assessment of their overall health. Higher scores indicate better functional ability.
Measured: Baseline, 3-months, and 6-months
Change from baseline disability to 3-months and 6-month follow-up
London Handicap Scale. The London Handicap Scale measures health status and includes domains of independent living skills: mobility, physical independence, occupation, social integration, orientation, and economic self-sufficiency. Higher scores indicate better functional ability.
Measured: Baseline, 3-months, and 6-months
Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up
Framingham Risk Score. Framingham Risk Score includes risk factors: age; sex; LDL cholesterol; HDL cholesterol; blood pressure; diabetes; and smoking. A higher score indicates worse outcomes.
Measured: Baseline, 3-months, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Feb 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Vinfen
- Responsible party
- Principal investigator, Karen L. Fortuna, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481737
- Sponsor's protocol ID
- D20155
- Status last verified
- Jan 2024
- First submitted
- 10 Jul 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Tools (data, assays, libraries, research tools, reagents, model organisms, etc.) will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data\_sharing) and Model Organism Sharing Policy (http://grants.nih.gov/grants/policy/model\_organism/index.htm), to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the Trustees of Dartmouth College (the institution) may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.
Publications
Fortuna KL, Cui S, Lebby S, Xie H, Bruce ML, Bartels SJ. PeerTECH: a randomized controlled trial of a peer-led mobile health intervention to improve medical and psychiatric self-management for persons with serious mental illness. Mhealth. 2025 Jun 30;11:28. doi: 10.21037/mhealth-24-64. eCollection 2025.
PubMed 40755935
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery
- ClinicalTrials.gov ID
- NCT04481737
- Acronym / sponsor ID
- D20155
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Recurrent, Obesity, Cardiovascular Diseases, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Harvard University, Vinfen
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 22 Jul 2020 (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.
Adults with serious mental illness (SMI) are disproportionately affected by medical comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to the general population. These high rates of morbidity and early mortality are associated with inadequately managed medical and psychiatric illnesses. A recent systematic review found nine effective self-management interventions that address medical and psychiatric illnesses in adults with SMI. However, there has been limited adoption of these interventions due to both provider and consumer-based factors. Provider-based barriers consist of the lack of an adequate workforce with the capacity, time, and knowledge of effective approaches to self-management support for adults with SMI and chronic health conditions. Consumer-based barriers associated with limited participation in self-management programs include lack of access, engagement, and ongoing community-based support for persons with SMI. Peer support specialists have the potential to address these barriers as they comprise one of the fastest growing sectors of the mental health workforce, have "lived experience" in self-management practices, and offer access to support in the community. However, challenges need to be resolved for peers to be effective providers of evidence-based interventions. For example, peers are frequently trained to provide "peer support" described as "giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful". Peer support has been associated with increased sense of control, ability to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not adhere to evidence-based practices for psychiatric and medical self-management and does not follow protocols that ensure fidelity and systematically monitor outcomes. The investigators hypothesize that mobile technology has the potential to overcome these limitations of peer support by providing real-time guidance in fidelity adherent delivery of a peer-delivered, technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator will build the necessary expertise to pursue a career developing and testing novel approaches to peer-delivered evidence-based self-management interventions. Training will include: development of peer-delivered interventions; development and design of mobile health-supported interventions; and intervention clinical trials research. Concurrently, this study includes refinement of the intervention protocol with input from peers and consumers and conducting a pilot study evaluating the feasibility and potential effectiveness of PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic health conditions. Outcomes include feasibility, medical and psychiatric self-management skills, functional ability, and mortality risk factors and examine self-efficacy and social support as mechanisms on outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDTA-IIMR | Experimental | Behavioral: Peer-delivered and Technology Support Integrated Illness Management and Recovery |
| Peer support | Active comparator | Behavioral: Peer support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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-delivered and Technology Support Integrated Illness Management and RecoveryPDTA-IIMR is delivered by a peer support specialist with the use of guided IIMR eModules and a smartphone application designed to complement in-person eModule sessions. The eModules are designed to be reviewed with a peer support specialist and consumer during one-hour, weekly, telephonic sessions in a community setting. Each eModule includes videos and experiential learning tasks on psychoeducation and coping skills training. | Behavioural | PDTA-IIMR |
| Peer supportPeer support is a non-manualized form of social support, frequently coupled with instrumental support, that is mutually offered or provided by persons having a mental health condition to others sharing a similar mental health condition to bring about a desired social or personal change. Peer support specialists are provided with 1-hour of supervision each week | Behavioural | Peer support |
Primary outcome
Change in number of study drop-outs, attendance, and adherence from baseline to 3-months
Time frame: Baseline and 3-months
Review case notes written by peer support specialists to examine count data on attrition, attendance, and patient adherence.
Change in average fidelity scores
Time frame: Baseline and 3-months
Peer Support specialists will independently rate themselves after each session using the PDTA-IIMR fidelity scale. The standards used for establishing the items and ratings were determined by expert sources and empirical research.
8 secondary outcomes
Change from baseline mortality risk index to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline self efficacy to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline social support to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline mental health self-management skills to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline medical self-management skills to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline functional ability to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline disability to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up
Time frame: Baseline, 3-months, and 6-months
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 24 Jan 2024.
- Derived from this study: PubMed 40755935Fortuna KL, Cui S, Lebby S, Xie H, Bruce ML, Bartels SJ. PeerTECH: a randomized controlled trial of a peer-led mobile health intervention to improve medical and psychiatric self-management for persons with serious mental illness. Mhealth. 2025 Jun 30;11:28. doi: 10.21037/mhealth-24-64. eCollection 2025.
- Individual participant dataSharing planned: Yes. Tools (data, assays, libraries, research tools, reagents, model organisms, etc.) will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing) and Model Organism Sharing Policy (http://grants.nih.gov/grants/policy/model_organism/index.htm), to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the Trustees of Dartmouth College (the institution) may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-delivered and Technology Support Integrated Illness Management and Recovery and Peer support in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center 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?
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 24 Jan 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?
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?
Change in number of study drop-outs, attendance, and adherence from baseline to 3-months (time frame: Baseline and 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481737, which also lists 1 linked publication.
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 24 Jan 2024.