Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks

Summary

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.

Conditions

• Mental Illness

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Jeffrey A. Kelly, PhD · Medical College of Wisconsin

• Carol L. Galletly, JD, PhD · Medical College of Wisconsin

• Anton M. Somlai, EdD · Medical College of Wisconsin

• Jill T. Owczarzak, PhD · Medical College of Wisconsin

• Timothy L. McAuliffe, PhD · Medical College of Wisconsin

• David W. Seal, PhD · Medical College of Wisconsin

• Thomas W. Heinrich, MD · Medical College of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2011-07-31

Completion

2011-07-31