PTSDNCT01957371
Mindful Yoga Therapy for Veterans With PTSD and Pain
A study testing Mindful Yoga Therapy in people with PTSD and Chronic Pain, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and chronic pain among OEF/OIF/OND Veterans. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- PTSD, Chronic Pain
- What is being tested?
- Mindful Yoga Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2015
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OIF/OEF/OND Veteran
- Ages 18-45
- A willingness to participate in yoga and ability to commit to two 75-minute sessions per week for 12 weeks.
- Currently enrolled (under active care) at the PTSD firm or the MST group at VACHS, West Haven
- Participants will meet clinical criteria of PTSD (DSM-IV-TR)
- Comorbid conditions, including substance abuse/dependence will be allowed except as noted under exclusion criteria.
- Veteran with combat exposure or military sexual trauma during deployment(s).
- Non-cancer pain score (NRS pain score > 4 on a 0-10 scale whereby 0=no pain and 10=worst pain imaginable) and presence of pain for >3 consecutive months
Who cannot join
- Any diagnosis of current comorbid psychotic disorders or bipolar disorder
- Active SI/HI
- Primary and only pain complaint as headache disorder
- A regular yoga or meditation practice in past month (more than twice weekly)
- Participants with significant limitations or injuries (Potential participants with significant limitations or injuries will be evaluated on an individual basis by research team and the yoga therapists.)
- Inability to speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Va Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Mindful Yoga Therapy as an Adjunctive Treatment for Veterans With PTSD and Pain
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore anxiety sensitivity as a mechanism of therapeutic action.
Read the detailed description
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive, and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT) is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot clinical trial will examine the efficacy of MYT with baseline, 12 week, and 24 week follow-up assessments that will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to the study purpose.
- Conditions
- PTSD, Chronic Pain
- Being tested
- Mindful Yoga Therapy
- Keywords
- PTSD, Yoga, Complementary and Alternative Medicine (CAM), Chronic Pain
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Yoga TherapyBehavioural
Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, physical postures/movements, and guided rest (yoga nidra), as well as daily home practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Yoga Therapy | Experimental | 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. Receives: Behavioral: Mindful Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M)
A 17-item self- report measure of PTSD symptoms.
Measured: 24 weeks
Numeric Rating Scale of Pain Intensity (NRS-I)
Global pain intensity will be assessed using the NRS-I, an 11-point numeric rating scale where a score of "0" represents no pain and a score of "10" represents the worst pain imaginable. Participants will be asked to rate their average current pain (e.g. today's pain) along with their average pain over the past week.
Measured: 24 weeks
Secondary outcomes (13)
West Haven Yale Multidimensional Pain Inventory - Interference Scale (WHYMPI-I)
The 9 item self-report Interference subscale of the WHYMPI will be used to assess pain-related disability.
Measured: 24 weeks
Mindful Yoga Therapy Evaluation of Treatment Questionnaire
Consists of 20 items that require individuals to rate different aspects of the treatment.
Measured: 24 weeks
Pain Treatment Credibility Questionnaire
A 3-item self-report measure developed to assess the credibility of Mindful Yoga as a viable intervention for pain.
Measured: 24 weeks
Pain Treatment Satisfaction Questionnaire
A 6-item self-report measure developed to assess satisfaction with MYT group logistics (time, frequency, duration, and format).
Measured: 24 weeks
Beck Depression Inventory (BDI)
A 21-item self- report scale of depression. Each item is rated on a 4-point scale with 0 as the low value 3 as the high value. A higher score indicates greater depression.
Measured: 24 Weeks
State-Trait Anxiety Inventory (STAI)
Trait anxiety measures relatively stable individual differences in anxiety proneness and refers to a general tendency to respond to perceived threats in the environment with anxiety reactions, whilst the state portion refers to current feelings of anxiety. Participants respond on a 4-point frequency scale ranging from "almost always" to "almost never" to items that reflect the either the presence or absence of anxiety
Measured: 24 weeks
Difficulties in Emotion Regulation Scale (DERS)
The DERS is a brief, 36-item, self- report questionnaire designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well as scores on six scales derived through factor analysis: 1) Nonacceptance of emotional responses (NONACCEPTANCE), 2) Difficulties engaging in goal directed behavior (GOALS), 3) Impulse control difficulties (IMPULSE), 4) Lack of emotional awareness (AWARENESS), 5) Limited access to emotion regulation strategies (STRATEGIES), 6) Lack of emotional clarity (CLARITY)
Measured: 24 weeks
Military Sexual Trauma
The presence of military sexual trauma will be assessed via the following "yes/no" questions: "While you were in the military, did you receive uninvited and unwanted sexual attention, such as touching, cornering, pressure for sexual favors, or sexual remarks?" and "Did someone ever use force or threat of force to have sexual contact with you against your will?"
Measured: 24 weeks
State-Trait Anger Scale (STAS)
The STAS consists of 20 statements that require individuals to rate how they generally feel on a four point scale and is designed to distinguish experiences of trait anger (a general tendency to react angrily to perceived situations) and state anger (a temporary emotional state).
Measured: 24 weeks
Quality of Life (QOL)
The Veterans SF-36 will be used to assess health-related quality of life. This measure has demonstrated good internal consistency (.78-.93 across 8 subscales) and is strongly correlated with socioeconomic status and morbidities.
Measured: 24 Weeks
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale is a 13-item self report scale that examines thoughts and feelings people may experience when they are in pain and are grouped into three different categories: Rumination, Magnification and Helplessness.
Measured: 24 weeks
Kentucky Inventory of Mindfulness Skills (KIMS)
The Kentucky Inventory of Mindfulness Skills is a 39-item self report measure assessing four facets of mindfulness including observing, describing, acting with awareness, and nonjudgment.
Measured: 24 weeks
Anxiety Sensitivity Index (ASI)
The Anxiety Sensitivity Index is a 16-item self-report measure that assesses fear of anxiety-related body sensations. Respondents rate the extent to which they agree with each statement using a 5 point Likert Scale.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alicia Heapy, Ph.D., Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957371
- Sponsor's protocol ID
- 01735
- Status last verified
- Dec 2014
- First submitted
- 29 Sep 2013
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Yoga Therapy as an Adjunctive Treatment for Veterans With PTSD and Pain
- ClinicalTrials.gov ID
- NCT01957371
- Acronym / sponsor ID
- 01735
- Conditions
- PTSD, Chronic Pain
- Keywords
- PTSD, Yoga, Complementary and Alternative Medicine (CAM), Chronic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 8 Oct 2013 (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.
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore anxiety sensitivity as a mechanism of therapeutic action.
Detailed description
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive, and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT) is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot clinical trial will examine the efficacy of MYT with baseline, 12 week, and 24 week follow-up assessments that will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to the study purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful Yoga Therapy | Experimental | Behavioral: Mindful Yoga Therapy12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- OIF/OEF/OND Veteran
- Ages 18-45
- A willingness to participate in yoga and ability to commit to two 75-minute sessions per week for 12 weeks.
- Currently enrolled (under active care) at the PTSD firm or the MST group at VACHS, West Haven
- Participants will meet clinical criteria of PTSD (DSM-IV-TR)
Key exclusion criteria (6 listed)
- Any diagnosis of current comorbid psychotic disorders or bipolar disorder
- Active SI/HI
- Primary and only pain complaint as headache disorder
- A regular yoga or meditation practice in past month (more than twice weekly)
- Participants with significant limitations or injuries (Potential participants with significant limitations or injuries will be evaluated on an individual basis by research team and the yoga therapists.)
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 |
|---|---|---|
| Mindful Yoga TherapyVeterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, physical postures/movements, and guided rest (yoga nidra), as well as daily home practice. | Behavioural | Mindful Yoga Therapy |
Primary outcome
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M)
Time frame: 24 weeks
A 17-item self- report measure of PTSD symptoms.
Numeric Rating Scale of Pain Intensity (NRS-I)
Time frame: 24 weeks
Global pain intensity will be assessed using the NRS-I, an 11-point numeric rating scale where a score of "0" represents no pain and a score of "10" represents the worst pain imaginable. Participants will be asked to rate their average current pain (e.g. today's pain) along with their average pain over the past week.
13 secondary outcomes
West Haven Yale Multidimensional Pain Inventory - Interference Scale (WHYMPI-I)
Time frame: 24 weeks
Mindful Yoga Therapy Evaluation of Treatment Questionnaire
Time frame: 24 weeks
Pain Treatment Credibility Questionnaire
Time frame: 24 weeks
Pain Treatment Satisfaction Questionnaire
Time frame: 24 weeks
Beck Depression Inventory (BDI)
Time frame: 24 Weeks
State-Trait Anxiety Inventory (STAI)
Time frame: 24 weeks
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 24 weeks
Military Sexual Trauma
Time frame: 24 weeks
State-Trait Anger Scale (STAS)
Time frame: 24 weeks
Quality of Life (QOL)
Time frame: 24 Weeks
Pain Catastrophizing Scale (PCS)
Time frame: 24 weeks
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: 24 weeks
Anxiety Sensitivity Index (ASI)
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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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.
Alicia Heapy, Ph.D. principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Yoga Therapy in people with PTSD and Chronic Pain, run by VA Connecticut Healthcare System 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Dec 2014. 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 withdrawn before enrolling participants, so there are no results.
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?
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) (time frame: 24 weeks). The study lists 2 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 9 Dec 2014.