Stress Disorders, Post-TraumaticNCT02224989
Mind-Body Intervention for Veterans With PTSD
A study testing Mind-Body Bridging in people with Stress Disorders, Post-Traumatic, run by University of Utah at 1 site in United States.
Trial summary
This pilot project evaluates the efficacy of a mind-body awareness training intervention, Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for relative therapeutic benefit will be indicated by the difference in outcomes from pre- to post-intervention for PTSD as the primary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Mind-Body Bridging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion of subjects will be based on: pre-screening score of 50 or greater on the PTSD Checklist for Military (PCL-M). Since we are also interested in the effects of MBB on co-morbid illnesses besides PTSD, we will include subjects who present with other behavioral health conditions, including sleep disturbance, depression, anxiety, pain, and any general medical conditions, except as defined as exclusion criteria. Subjects using anti-anxiety, anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Participants must be willing to commit to the 10-week course and complete all outcome measures, be literate in English and able to provide informed consent.
- Participants will be asked to refrain from engaging in other PTSD treatment programs for the duration of the proposed study, but can remain on their medications and continue with their usual medical or mental health care. They will also be allowed to continue with other activities (such as physical exercise, meditation, yoga, etc.), which they may have already incorporated into their life.
Who cannot join
- A patient will be excluded from the study under the following conditions:
- currently enrolled in active PTSD treatment program.
- identifying with major psychopathology (i.e., schizophrenia, mania, or poorly controlled bipolar disorder, borderline or antisocial personality disorder) and was psychiatrically hospitalized within the past 90 days.
- cognitive impairment or dementia.
- severe medical disease such as uncontrolled hypertension or diabetes, or terminal illness, e.g., cancer.
- active substance abuse disorder
- suicidal ideation with intent
Trial locations and contacts
1 site in 1 country.
United States1 site
Salt Lake City Veterans Affairs Health Care System
Salt Lake City, Utah, 84148
About this study
Official title: A Pilot Feasibility Study of a Novel Mind-body Intervention Program for Veterans With PTSD
This pilot project evaluates the efficacy of a mind-body awareness training intervention, Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for relative therapeutic benefit will be indicated by the difference in outcomes from pre- to post-intervention for PTSD as the primary outcome.
Read the detailed description
PTSD is a difficult illness to treat and there is a lack of interventions that effectively reduce it. In recent years, attention has focused on treating PTSD patients by including a sleep-focused intervention since those with PTSD, such as military personnel, almost always report some form of sleep disturbance (Neylan et al. 1998; Lewis et al. 2009). In fact, since sleep disturbance is so prevalent in PTSD, it is considered a hallmark of PTSD diagnosis (Ross et al. 1989). Two classical PTSD symptoms, hyperarousal and re-experiencing the traumatic event, comprise sleep difficulty and nightmares, respectively (Lamarche and De Koninck 2007). Preliminary evidence suggests that interventions targeting sleep may be beneficial in the treatment of PTSD (Germain et al. 2007; Swanson et al. 2009; Nakamura et al. 2011).
This study will evaluate the effectiveness of mind-body bridging (MBB) as a primary group psychotherapy treatment for reduction of PTSD symptoms among veterans. MBB is an awareness training program,(Block and Block 2007) which has been recently developed into a workbook specifically for PTSD (Block and Block 2010). MBB has been used successfully at the George E. Wahlen Veterans Affairs Medical Center (VAMC) for more than 5 years as an adjunctive treatment. MBB is well accepted by veterans and anecdotally has been reported to improve mood as well as PTSD and other anxiety symptoms. Furthermore, published pilot studies have provided preliminary evidence of its benefits.(Tollefson et al. 2009; Nakamura et al. 2011). In particular, Nakamura et al.(2011) tested a brief sleep-focused MBB intervention program in a randomized controlled trial, which demonstrated improved sleep and decreased PTSD symptoms. Our clinical experience and these preliminary studies indicate that a pilot feasibility study of MBB as a specific treatment for PTSD is warranted.
The proposed, non-randomized single-group study of MBB will serve as a pilot feasibility study investigating a 10-week MBB program offered to veterans who are clinically diagnosed to suffer from PTSD. In this pilot study, we determine whether MBB is a beneficial intervention program for PTSD and co-morbidities, including insomnia, depression, etc., based on self-report measures and clinical evaluations.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Mind-Body Bridging
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body BridgingBehavioural
An awareness training program. One 2 hr class per week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Bridging | Experimental | An awareness training program using mindfulness-based techniques. Receives: Behavioral: Mind-Body Bridging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up.
The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on the Diagnostic and Statistical Manual-IV (DSM-IV) criteria, and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up
Secondary outcomes (8)
Change in subjective measure of sleep using the Medical Outcomes Study - Sleep Scale (MOS-SS), from baseline to 3-month follow-up.
The MOS-SS is a 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The MOS-SS provides an index of sleep problems, including sleep disturbance, sleep adequacy, daytime somnolence, snoring, waking up short of breath with a headache, and quantity of sleep. The MOS-SS was validated as a retrospective assessment of sleep performance over the previous 4 weeks, and compares favorably with the Pittsburgh Sleep Quality Index (PSQI). We have used a modified version of MOS-SS to assess the subject's sleep patterns over the previous 7 days.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of resilience using the Response to Stressful Experience Scale (RSES), from baseline to 3-month follow-up.
The RSES is a multidimensional measure of resilience validated in a large sample of active-duty and reserve military personnel. This 22-item scale demonstrates good internal consistency. Confirmatory factor analysis revealed reasonable fit for a model of resilience comprising six-dimensions: (1) Cognitive Flexibility, (2) Spirituality, (3) Active Coping, (4) Self-efficacy, (5) Making-meaning, and (6) Restoration. The major strength of this scale is that it is indexed to a specific traumatic or extremely stressful event, such as combat and operational stress in military personnel. .
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of Health Related Quality of Life using the Medical Outcomes Study SF-36 for Veterans (VR-36), from baseline to 3-month follow-up.
Medical Outcomes Study Short Form-36 (SF-36) for Veterans (VR-36). The VR-36 is a modification of the original SF-36, adapted for Veterans. It consists of the same eight sections as the SF-36. The instrument provides a global score, as well as the following subscale scores: functional capacity, physical aspects, pain, general health condition, vitality, social aspects and emotional aspects, and mental health.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of depression using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline to 3-month follow-up.
The CES-D is one of the most common validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of mindfulness using the Five-facet Mindfulness Questionnaire (FFMQ), from baseline to 3-month follow-up.
The FFMQ includes 39 items and assesses five distinct, interpretable facets of mindfulness, including: 1) observing, 2) describing, 3) acting with awareness, 4) non-judging of inner experience, and 5) non-reactivity to inner experience.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of well-being using the Well-Being Index (WBI), from baseline to 3-month follow-up.
The WBI is a five item scale evaluating both positive and negative aspects of emotional functioning, developed and validated by the World Health Organization Collaborating Centre in Mental Health.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of health-related quality of life using the Medical Outcomes Study Short Form - 12 (SF-12), from baseline to 3-month follow-up.
The SF-12 is a much shortened version of the SF-36, comprising 12 items. It will be measured on a weekly basis.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of quality of life using the Mind-Body Bridging Quality of Life scale (MBB QOL), from baseline to 3-month follow-up.
The MBB QOL is a non-validated questionnaire used to assess the effects of MBB on quality of life.
Measured: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startApr 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: 1\) Difficulties in recruiting veterans and 2) the funding was used up completely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshio Nakamura, University of Utah
- Investigators
- Yoshio Nakamura, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224989
- Sponsor's protocol ID
- IRB_00052611
- Status last verified
- May 2018
- First submitted
- 21 Aug 2014
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of a Novel Mind-body Intervention Program for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT02224989
- Acronym / sponsor ID
- IRB_00052611
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1\) Difficulties in recruiting veterans and 2) the funding was used up completely
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project evaluates the efficacy of a mind-body awareness training intervention, Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for relative therapeutic benefit will be indicated by the difference in outcomes from pre- to post-intervention for PTSD as the primary outcome.
Detailed description
PTSD is a difficult illness to treat and there is a lack of interventions that effectively reduce it. In recent years, attention has focused on treating PTSD patients by including a sleep-focused intervention since those with PTSD, such as military personnel, almost always report some form of sleep disturbance (Neylan et al. 1998; Lewis et al. 2009). In fact, since sleep disturbance is so prevalent in PTSD, it is considered a hallmark of PTSD diagnosis (Ross et al. 1989). Two classical PTSD symptoms, hyperarousal and re-experiencing the traumatic event, comprise sleep difficulty and nightmares, respectively (Lamarche and De Koninck 2007). Preliminary evidence suggests that interventions targeting sleep may be beneficial in the treatment of PTSD (Germain et al. 2007; Swanson et al. 2009; Nakamura et al. 2011).
This study will evaluate the effectiveness of mind-body bridging (MBB) as a primary group psychotherapy treatment for reduction of PTSD symptoms among veterans. MBB is an awareness training program,(Block and Block 2007) which has been recently developed into a workbook specifically for PTSD (Block and Block 2010). MBB has been used successfully at the George E. Wahlen Veterans Affairs Medical Center (VAMC) for more than 5 years as an adjunctive treatment. MBB is well accepted by veterans and anecdotally has been reported to improve mood as well as PTSD and other anxiety symptoms. Furthermore, published pilot studies have provided preliminary evidence of its benefits.(Tollefson et al. 2009; Nakamura et al. 2011). In particular, Nakamura et al.(2011) tested a brief sleep-focused MBB intervention program in a randomized controlled trial, which demonstrated improved sleep and decreased PTSD symptoms. Our clinical experience and these preliminary studies indicate that a pilot feasibility study of MBB as a specific treatment for PTSD is warranted.
The proposed, non-randomized single-group study of MBB will serve as a pilot feasibility study investigating a 10-week MBB program offered to veterans who are clinically diagnosed to suffer from PTSD. In this pilot study, we determine whether MBB is a beneficial intervention program for PTSD and co-morbidities, including insomnia, depression, etc., based on self-report measures and clinical evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Bridging | Experimental | Behavioral: Mind-Body BridgingAn awareness training program using mindfulness-based techniques. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion of subjects will be based on: pre-screening score of 50 or greater on the PTSD Checklist for Military (PCL-M). Since we are also interested in the effects of MBB on co-morbid illnesses besides PTSD, we will include subjects who present with other behavioral health conditions, including sleep disturbance, depression, anxiety, pain, and any general medical conditions, except as defined as exclusion criteria. Subjects using anti-anxiety, anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Participants must be willing to commit to the 10-week course and complete all outcome measures, be literate in English and able to provide informed consent.
- Participants will be asked to refrain from engaging in other PTSD treatment programs for the duration of the proposed study, but can remain on their medications and continue with their usual medical or mental health care. They will also be allowed to continue with other activities (such as physical exercise, meditation, yoga, etc.), which they may have already incorporated into their life.
Key exclusion criteria (7 listed)
- A patient will be excluded from the study under the following conditions:
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 |
|---|---|---|
| Mind-Body BridgingAn awareness training program. One 2 hr class per week for 10 weeks. | Behavioural | Mind-Body Bridging |
Primary outcome
Change in the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up
The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on the Diagnostic and Statistical Manual-IV (DSM-IV) criteria, and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.
8 secondary outcomes
Change in subjective measure of sleep using the Medical Outcomes Study - Sleep Scale (MOS-SS), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of resilience using the Response to Stressful Experience Scale (RSES), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of Health Related Quality of Life using the Medical Outcomes Study SF-36 for Veterans (VR-36), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of depression using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of mindfulness using the Five-facet Mindfulness Questionnaire (FFMQ), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of well-being using the Well-Being Index (WBI), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of health-related quality of life using the Medical Outcomes Study Short Form - 12 (SF-12), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Change in subjective measure of quality of life using the Mind-Body Bridging Quality of Life scale (MBB QOL), from baseline to 3-month follow-up.
Time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Results and safety
The study was stopped early (reason given: 1\) Difficulties in recruiting veterans and 2) the funding was used up completely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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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.
Yoshio Nakamura, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Bridging in people with Stress Disorders, Post-Traumatic, run by University of Utah 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 May 2018. 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?
The study was stopped early (reason given: 1\) Difficulties in recruiting veterans and 2) the funding was used up completely). Results are not available in the source record.
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?
Change in the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up. (time frame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up). 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 7 May 2018.