NCT04481737Completed
Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery
Source: ClinicalTrials.gov · Last updated 24 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 10 Jul 2020
- Start date
- 1 Feb 2021
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Diseases
- Schizophrenia, Obesity, Depression, Bipolar disorder
- NCT number
- NCT04481737
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Feb 2021 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vinfen Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.