Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery

NCT04481737 | Completed DMC

• 1 other identifier: D20155
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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; Smoking; Blood Pressure Disorders; Cholesterol, Elevated

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 3-months

Secondary Outcomes (8)

• Change from baseline mortality risk index to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

• Change from baseline self efficacy to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

• Change from baseline social support to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

• Change from baseline mental health self-management skills to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

• Change from baseline medical self-management skills to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

Other Outcomes (2)

• Change from baseline level of loneliness to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

• Change from baseline patient satisfaction to 3-months and 6-month follow-up

  Baseline, 3-months, and 6-months

Study Arms (2)

PDTA-IIMR

EXPERIMENTAL

Behavioral: Peer-delivered and Technology Support Integrated Illness Management and Recovery

Peer support

ACTIVE COMPARATOR

Behavioral: Peer support

Interventions

Peer-delivered and Technology Support Integrated Illness Management and Recovery BEHAVIORAL

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.

PDTA-IIMR

Peer support BEHAVIORAL

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

Peer support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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;

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Harvard University: collaborator
• Vinfen: collaborator

Study Sites (1)

Vinfen

Cambridge, Massachusetts, 02141, United States

Location

Related Publications (1)

• 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.

  PMID: 40755935 DERIVED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Recurrence; Obesity; Cardiovascular Diseases; Diabetes Mellitus; Smoking; Hypercholesterolemia

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 22, 2020
• Study Start: February 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)