Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the effectiveness of a cognitive behavioral treatment in reducing significant medical risk factors often associated with people who have a serious mental illness and are taking atypical antipsychotic medications.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis

NCT03970005

Prodromal Schizophrenia

ENROLLING_BY_INVITATION

Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy

NCT00791440

Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

COMPLETED NA

Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia

NCT00455663

Schizophrenia

COMPLETED NA

Shared Decision Making for Antipsychotic Medications

NCT05416658

Schizophrenia Schizoaffective Disorder Schizophreniform Disorders +2 more

NOT_YET_RECRUITING NA

Exercise and Markers of Medial Temporal Health in Youth At-risk for Psychosis

NCT02155699

Attenuated Psychosis Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Serious mental illness encompasses a large range of symptoms varying in severity, but generally includes symptoms described as both positive and negative. Positive symptoms include confused thinking, delusions, and hallucinations, while negative symptoms include lack of emotion and depression. Because novel or atypical antipsychotic medications target both positive and negative symptoms and have fewer side effects than other medications, they make up the current standard of care for the treatment of many mental illnesses. However, there is growing concern that the psychiatric benefits associated with atypical antipsychotic medications are offset by serious negative medical consequences, including weight gain, obesity-related cardiovascular risk, insulin resistance, and diabetes. Behavioral interventions that aim to help people coping with serious mental illness to reduce weight, sustain weight loss, and achieve better fitness may improve the risk/benefit ratio of atypical antipsychotic medications. A small-group cognitive behavioral intervention that provides peer and structural risk-reduction support may be the most beneficial means of promoting healthy eating and exercise habits in people with serious mental illness who are living in group homes. This study will evaluate the effectiveness of a small-group cognitive behavioral intervention conducted in group homes for reducing significant medical risk factors often associated with people who have a serious mental illness and are taking atypical antipsychotic medications.

Participation in this study will last about 18 months through follow-up. All participants will undergo baseline assessments that will include the following: measurements of diet and exercise patterns, using self-report and observational methods; measurements of weight, body mass index, body fat distribution, pulse rate, and blood pressure; blood draws; and questions about psychological well-being and quality of life. Group homes will then be assigned randomly to provide participating residents with either the cognitive behavioral intervention or the time-matched attention control program. Participants in both groups will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. The cognitive behavioral sessions will focus on promoting healthy behaviors, dieting, and exercise. The time-matched attention control sessions will focus on improving communications, developing healthy techniques for coping with stress, and resolving conflicts. After completing treatment, all participants will receive 6 monthly 1-hour booster sessions of their assigned treatments. They will also repeat the baseline assessments 3 times over the following 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Home

Participants will receive cognitive behavioral sessions.

Group Type EXPERIMENTAL

Cognitive behavioral sessions

Intervention Type BEHAVIORAL

Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on promoting healthy behaviors, dieting, and exercise.

Control

Participants will receive time-matched attention control sessions.

Group Type ACTIVE_COMPARATOR

Time-matched attention control sessions

Intervention Type BEHAVIORAL

Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on improving communications, developing healthy techniques for coping with stress, and resolving conflicts.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavioral sessions

Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on promoting healthy behaviors, dieting, and exercise.

Intervention Type BEHAVIORAL

Time-matched attention control sessions

Participants will receive 26 weekly 1-hour small-group sessions and 26 weekly 30-minute individual sessions with a study facilitator. After completing treatment, participants will also receive 6 monthly 1-hour booster sessions. All sessions will focus on improving communications, developing healthy techniques for coping with stress, and resolving conflicts.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Resides in one of the designated group homes

Exclusion Criteria

* Sufficiently impaired because of a psychiatric illness, as reflected in mental status in which informed judgment about study participation cannot be assured at the time of study entry
* Medical contraindication to study participation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No