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Can a tailored self-management program improve health outcomes for those with serious mental illness?

NCT ID NCT03966872

Disease control Sponsor: Dartmouth-Hitchcock Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial compares two group-based education programs for people with serious mental illness who also have chronic physical conditions like diabetes or heart disease. One program, Integrated Illness Management and Recovery (I-IMR), covers both mental and physical health self-management, while the other, the Chronic Disease Self-Management Program (CDSMP), focuses mainly on physical health. Researchers want to see which approach better improves patients' knowledge, skills, and health outcomes, and reduces hospital visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Integrated Illness Management and Recovery (I-IMR) and Chronic Disease Self-Management Program (CDSMP) — behavioral education and skills training groups
What this could lead to
If one program proves more effective, it could become a standard approach to help people with serious mental illness better manage both their mental and physical health.
What could go wrong
This is a comparative effectiveness study, not a test of a new drug, so the benefits may be modest. Results depend on participant engagement and may not apply to all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

601 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Serious Mental Illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at Centerstone(KY and TN) * Diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease (e.g., diabetes, hyperlipidemia, hypertension, COPD, heart failure, tobacco dependence, obesity), and at least 1 ER visit or hospitalization within the past year or judgment by the treatment team of substantial need for illness self-management training. Exclusion Criteria: * Consumers who do not speak English * Consumers with either no, or a well-controlled medical condition will not be included * Individuals residing in a nursing home or other institution * Evidence of significant cognitive impairment as indicated by a Mini Mental Status Examination score \<24, will be excluded Eligibility for the COVID -related substudy is dependent on enrollment and participation in the parent project.

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Conditions

The condition(s) this trial relates to.

bipolar disorder cardiovascular disorder Chronic Disease major depressive disorder psychiatric disorder Psychological Well-Being schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic disease Mental illness

Contacts and locations

Locations

  • Centerstone

    Nashville, Tennessee, 37228, United States

  • Seven Counties Services

    Louisville, Kentucky, 40220, United States

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