ACTIVE_NOT_RECRUITING

Effectiveness RCT of Customized Adherence Enhancement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Building upon positive efficacy trial results, the proposed project will test the effectiveness of technology-facilitated Customized Adherence Enhancement (CAE) vs. enhanced treatment as usual (eTAU) using a prospective randomized controlled design in public mental health care settings and preferentially enrolling poorly adherent/high-risk individuals with BD. Deliverables include a curriculum-driven adherence enhancement approach that can be implemented in public healthcare settings and which can improve outcomes for the most vulnerable groups of people with BD.

Official Title

Effectiveness RCT of Customized Adherence Enhancement

Quick Facts

Study Start:2022-02-01

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04622150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Martha Sajatovic, MD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Study Locations (Sites)

W.O. Walker Center

Cleveland, Ohio, 44106

United States

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

The Nord Center

Lorain, Ohio, 44053

United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

Martha Sajatovic, MD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

Bipolar Disorder