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New behavioral program aims to solve medication adherence in bipolar disorder

NCT ID NCT04622150

Disease control Sponsor: Case Western Reserve University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

About half of people with bipolar disorder struggle to take their medication as prescribed, which can lead to severe consequences. This study tested a customized program called Customized Adherence Enhancement (CAE) that includes education, motivational interviewing, and help with medication routines. Researchers enrolled 190 adults with bipolar disorder in public mental health clinics to see if CAE improves adherence compared to usual care.

What this could mean

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

Active substance
Customized Adherence Enhancement (CAE) - a behavioral program with modules like education, motivational interviewing, and medication routines
What this could lead to
If it works, this could provide a practical, evidence-based tool for mental health clinics to help people with bipolar disorder take their medication more consistently.
What could go wrong
This is a completed trial with 190 participants, but it tests a behavioral intervention, not a drug, so results may be modest and depend on how well clinics adopt the program.

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

190 people

The number who actually took part.

Started

Feb 2022

Finished

May 2026

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 to 89 years

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.

Patients receiving care at the Nord Center, MetroHealth system, and other not-for-profit health systems. Inclusion Criteria: 1. Participants will have a diagnosis of Bipolar Disorder Type I or Type II determined by the Structured Clinical Interview for DSM-5 patient version (SCID-P). 2. Have had BD for at least two years duration 3. Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer) 4. Yes to either of the following questions: 1. Do you ever have any trouble taking all of your medications? Or 2. Do you ever try to cope on your own without medication? 5. a BPRS ≥ 36 or YRMS ≥8 or MADRS ≥8 6. Be able to participate in psychiatric interviews and give written informed consent 7. Have their own cellular phone in order to receive text messages as part of the intervention Exclusion Criteria: 1. Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales 2. Unable or unwilling to give written, informed consent to study participation 3. Individuals who participated in Phase 1 of the study 4. Children under the age of 18 5. Individuals at high risk for suicide who cannot be safely managed in their current treatment setting

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

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

Bipolar disorder

Contacts and locations

Locations

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • The Nord Center

    Lorain, Ohio, 44053, United States

  • W.O. Walker Center

    Cleveland, Ohio, 44106, United States

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