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Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia

Mindfulness as a Rehabilitation Strategy in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00936351
Enrollment
34
Registered
2009-07-10
Start date
2007-12-31
Completion date
2010-12-31
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders, Schizoaffective Disorder, Schizophrenia

Keywords

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

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.

Detailed description

Objectives: Schizophrenia involves numerous difficulties including being aware of ones' own thoughts and tolerating painful affects. As a result, persons with schizophrenia find coping with life stressors quite challenging and thus have difficulty engaging successfully in psychosocial activities such as work in spite of state of the art programs. To address this problem this study will evaluate an intervention that has come to the fore that targets these impairments called mindfulness. 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. Use of mindfulness skills with other populations has led to more sustained behavior change than occurs with standard treatments. Recently research has begun to indicate mindfulness interventions can be delivered with success for individuals with schizophrenia. This pilot study will be a first step in adapting mindfulness as a cognitive intervention for individuals with schizophrenia who are engaging in vocational rehabilitation in order to maintain their functional gains beyond the end of the program. Key questions to be answered through this study include: (1) Can a mindfulness manual be developed that helps persons with schizophrenia enrolled in vocational rehabilitation exhibit better work function and reduced levels of distressing emotional states and thinking patterns?; (2) Can materials necessary for the faithful transmission of the mindfulness group intervention/manual (MGI) in the current study be created?; (3) Can mindfulness skills be adapted and successfully taught to and accepted by persons with schizophrenia in a group setting?: (4) Will individuals with schizophrenia who practice mindfulness benefit?; (5) What are the effect sizes with a reasonable control to study the effectiveness of the manualized MGI? Research Design: This study will take place over 3 years and is divided into two phases: manual development and pilot study. In the manual development phase existing mindfulness protocols will be adapted to target work function of persons with schizophrenia. The randomized controlled pilot study phase will explore the effects of the intervention on key outcome measures. Methodology: A total of 52 individuals with schizophrenia or schizoaffective disorder will be recruited from the Roudebush VA Medical Center (18 in the non-randomized, non-controlled manual development phase 1 and 34 in the randomized controlled pilot phase 2). In phase one, manual development, 18 participants will be recruited and following informed consent, screened for eligibility using the SCID and anxiety measures. Once enrolled, three successive groups of 6 participants will attend an 8-week mindfulness program consisting of two 60-minute group training and practice sessions each week. The mindfulness program will incorporate didactic and experiential elements aimed at learning mindfulness skills and establishing a daily mindfulness practice. Based on the experience gained working with each of these three initial cohorts, a mindfulness manual will be created. In phase two, the pilot of the mindfulness manual, 34 additional participants will be recruited and randomized to the mindfulness intervention or support group control. All groups will complete assessments at baseline, monthly, at program end and 6 months after program end as well as formative and summative program evaluations. Clinical Significance: Results of this study will yield materials necessary to begin the process of assembling a body of research validating scientifically the therapeutic value of mindfulness for veterans with schizophrenia who are enrolled in vocational rehabilitation. Findings may ultimately provide the VA system with information regarding a potentially cost effective approach to the care of these veterans who are disabled by a chronic mental illness that would be exportable to other VA vocational rehabilitation programs that have patients with schizophrenia.

Interventions

BEHAVIORALMindfulness Meditation

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.

BEHAVIORALSupport Group (control)

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.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* history of mental retardation * active substance abuse

Design outcomes

Primary

MeasureTime frameDescription
Hoursweek 1 through week 24 of treatmenttotal hours worked over the duration of the 24-week treatment
Work Behavior Inventoryweek 24The 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.
Weeksweeks 1-24Vocational 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Mindfulness Meditation 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.
18
Arm 2
Support Group Support Group (control): 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.
16
Total34

Baseline characteristics

CharacteristicArm 2TotalArm 1
Age, Customized50.1 years
STANDARD_DEVIATION 10.6
51.7 years
STANDARD_DEVIATION 8.51
53.2 years
STANDARD_DEVIATION 6.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants21 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants13 Participants6 Participants
Region of Enrollment
United States
16 participants34 participants18 participants
Sex: Female, Male
Female
0 Participants1 Participants1 Participants
Sex: Female, Male
Male
16 Participants33 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 180 / 16
serious
Total, serious adverse events
0 / 180 / 16

Outcome results

Primary

Hours

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

Time frame: week 1 through week 24 of treatment

Population: 3 participants were not included due to early dropout

ArmMeasureValue (MEAN)Dispersion
Arm 1Hours293.5 total hours worked during treatmentStandard Deviation 40.2
Arm 2Hours234.5 total hours worked during treatmentStandard Deviation 96.1
p-value: 0.04t-test, 2 sided
Primary

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.

Time frame: weeks 1-24

ArmMeasureValue (MEAN)Dispersion
Arm 1Weeks15.2 total number of weeksStandard Deviation 1.9
Arm 2Weeks12.8 total number of weeksStandard Deviation 4.7
Primary

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.

Time frame: week 24

ArmMeasureValue (MEAN)Dispersion
Arm 1Work Behavior Inventory3.6 units on a scaleStandard Deviation 0.4
Arm 2Work Behavior Inventory3.0 units on a scaleStandard Deviation 0.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026