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.
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
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Mindfulness Meditation Receives: 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 Receives: Behavioral: Support Group (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours
total hours worked over the duration of the 24-week treatment
Measured: 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.
Measured: 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.
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.
- First posted10 Jul 2009 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Louanne W Davis, PsyD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness as a Rehabilitation Strategy in Schizophrenia
- ClinicalTrials.gov ID
- NCT00936351
- Acronym / sponsor ID
- D4786-W
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- Keywords
- schizophrenia, intervention studies, mindfulness meditation, vocational rehabilitation, schizoaffective disorder, psychotic disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Mindfulness MeditationMindfulness Meditation |
| Arm 2 | Active comparator | Behavioral: Support Group (control)Support Group that involves discussion of work-related issues in which participants are facilitated to assist each other with problem solving and offer support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- history of mental retardation
- active substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationMindfulness 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. | Behavioural | Arm 1 |
| 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. | Behavioural | Arm 2 |
Primary outcome
Hours
Time frame: week 1 through week 24 of treatment
total hours worked over the duration of the 24-week treatment
Work Behavior Inventory
Time frame: week 24
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.
Weeks
Time frame: weeks 1-24
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louanne W Davis, PsyD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
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.