Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia

NCT00936351 | Completed Results

• 2 other identifiers: D4786-W0611-01B
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a treatment manual for mindfulness meditation to be taught in a group format to individuals with schizophrenia who are engaged in vocational rehabilitation. This study will also determine whether mindfulness meditation is beneficial in terms of improving work function by reducing distressing emotional states and thinking patterns.

Conditions

Schizophrenia; Schizoaffective Disorder; Psychotic Disorders

Keywords

schizophrenia; intervention studies; mindfulness meditation; vocational rehabilitation; schizoaffective disorder; psychotic disorders

Outcome Measures

Primary Outcomes (3)

• Hours

  total hours worked over the duration of the 24-week treatment

  week 1 through week 24 of treatment

• Work Behavior Inventory

  The Work Behavior Inventory (WBI: Bryson, et al., 1997) assesses work performance for persons with severe mental illness based on a trained rater's observation of participants at work and an interview with their supervisor. Each of the 35 WBI items are rated as 1- 5 ("persistent problem area" to "frequent area of strength"). The total score is the sum of five sub-scales (social skills, cooperativeness, work habits, work quality, and personal presentation). We divided the total score by 35 to produce a mean score that is conducive to interpretation since there are no established cut-offs for interpretation of the total score. Thus the mean scores range from 1-5 and are interpretable based on the anchors for the likert scale ranging from 1 (persistent problem area" to 5 ("frequent area of strength). Good to excellent interrater reliability was found for raters in this study, with intraclass correlations of .79-.98.

  week 24

• Weeks

  Vocational rehabilitation staff tracked weekly work hours verified by supervisors and reported the data to study staff during the 24-week interventions. Therefore possible values for total weeks worked range from 1-24.

  weeks 1-24

Study Arms (2)

Arm 1

EXPERIMENTAL

Mindfulness Meditation

Behavioral: Mindfulness Meditation

Arm 2

ACTIVE COMPARATOR

Support Group that involves discussion of work-related issues in which participants are facilitated to assist each other with problem solving and offer support

Behavioral: Support Group (control)

Interventions

Mindfulness Meditation BEHAVIORAL

Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment.

Arm 1

Support Group (control) BEHAVIORAL

A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion.

Arm 2

Eligibility Criteria

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

You may qualify if:

• patients with SCID I confirmed DSM-iV diagnosis of schizophrenia or schizoaffective disorder
• in a post acute phase of illness defined by no hospitalizations or changes in type of psychotropic medication or place of residence in the past 30 days
• who are either already enrolled in vocational rehabilitation and working or willing to enroll in vocational rehabilitation and begin working

You may not qualify if:

• history of mental retardation
• active substance abuse

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Mindfulness; Self-Help Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Organizations; Health Care Economics and Organizations

Limitations and Caveats

The sample was middle-aged males with chronic schizophrenia, not representative of the broader population. Raters of work quality were not blinded to condition. Mindfulness and support conditions were not equally matched on intensity of intervention.

Results Point of Contact

• Title: Louanne W. Davis PsyD
• Organization: Roudebush VA Medical Center

louanne.davis@va.gov

317-988-4523

Study Officials

• Louanne W Davis, PsyD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 10, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-03

Locations

US (1)