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SchizophreniaNCT00936351

Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia

A study testing Mindfulness Meditation in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mindfulness Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
Dec 2007to Dec 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • history of mental retardation
  • active substance abuse

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

Official title: Mindfulness as a Rehabilitation Strategy in Schizophrenia

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.

Read the 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.

Being tested
Mindfulness Meditation, Support Group (control)
Keywords
schizophrenia, intervention studies, mindfulness meditation, vocational rehabilitation, schizoaffective disorder, psychotic disorders
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness MeditationBehavioural

    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.

  • Support Group (control)Behavioural

    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.

Study groups in NCT00936351
Study groupRoleWhat they receive
Arm 1ExperimentalMindfulness Meditation
Receives: Behavioral: Mindfulness Meditation
Arm 2Active comparatorSupport Group that involves discussion of work-related issues in which participants are facilitated to assist each other with problem solving and offer support
Receives: Behavioral: Support Group (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hours

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

    Measured: week 1 through week 24 of treatment

  2. 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.

    Measured: week 24

  3. 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.

    Measured: weeks 1-24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2009 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00936351
Sponsor's protocol ID
D4786-W
Other IDs
0611-01B
Status last verified
Mar 2015
First submitted
8 Jul 2009
Last updated
10 Apr 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Meditation in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hours (time frame: week 1 through week 24 of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.

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