Behavioral Intervention to Reduce Novel Antipsychotic Medication Health Risks

NCT00709345 | Completed Phase 1

• 1 other identifier: R01MH078576
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Antipsychotic Medications; Behavioral Interventions

Outcome Measures

Primary Outcomes (1)

• Average weight loss; body mass index; and effects across other behavioral, clinical, physiological, and ancillary measures

  Measured at Month 12

Secondary Outcomes (1)

• Ability of behavioral intervention to offset significant medical risk factors often associated with people living with mental illness

  Measured at Month 12

Study Arms (2)

Group Home

EXPERIMENTAL

Participants will receive cognitive behavioral sessions.

Behavioral: Cognitive behavioral sessions

Control

ACTIVE COMPARATOR

Participants will receive time-matched attention control sessions.

Behavioral: Time-matched attention control sessions

Interventions

Cognitive behavioral sessions 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.

Group Home

Time-matched attention control sessions 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resides in one of the designated group homes

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Jeffrey A. Kelly, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Carol L. Galletly, JD, PhD

  Medical College of Wisconsin

  STUDY DIRECTOR

• Anton M. Somlai, EdD

  Medical College of Wisconsin

  STUDY DIRECTOR

• Jill T. Owczarzak, PhD

  Medical College of Wisconsin

  STUDY DIRECTOR

• Timothy L. McAuliffe, PhD

  Medical College of Wisconsin

  STUDY DIRECTOR

• David W. Seal, PhD

  Medical College of Wisconsin

  STUDY DIRECTOR

• Thomas W. Heinrich, MD

  Medical College of Wisconsin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Medicine

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 3, 2008
• Study Start: July 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 23, 2024

Record last verified: 2024-04