Post-Traumatic Stress DisordersNCT00778960
Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
A study testing Slow Breathing, Meditation and Meditation and slow breathing in people with Post-Traumatic Stress Disorders, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorders
- What is being tested?
- Slow Breathing, Meditation and Meditation and slow breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2014
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Combat veteran (defined by a score of ≥7 on the Combat exposure scale)
- Chronic PTSD diagnosis
- Age range (25-65 years)
- Both genders
- Good general medical health
- Stable dose of medications for concurrent stable medical conditions for at least 4 weeks prior to start of the study.
- Willing and able to provide informed consent.
Who cannot join
- Significant chronic medical illness including:
- current cancer treatment,
- unstable angina,
- recent myocardial infarction,
- current or past history of stroke,
- transient ischemic attack,
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- congestive heart failure,
- chronic renal or hepatic failure,
- hypothyroidism
- Psychiatric or behavioral illness including:
- schizophrenia,
- schizoaffective disorder,
- bipolar disorder,
- psychotic disorder (not including transient dissociative states or flashbacks associated with PTSD re-experiencing symptoms),
- any DSM-IV cognitive disorder,
- current delirium,
- psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to the patient or others.
- Substance dependence disorder within 3 months of the study or
- current substance use other than alcohol (no more than 2 drinks/day by self-report)
- Sexual assault as primary PTSD event/s.
- Planning to move from the area in the next year.
- Prior or current meditation practice.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms.
Read the detailed description
This study requires nine visits to the clinic: one screening visit, one baseline visit, six training sessions, and one endpoint visit. There will be approximately 100 people enrolled in this study who will be randomly allocated to one of four groups: a slow breathing group, a meditation group, a meditation plus slow breathing group and a sitting quietly group.
Participants will undergo a telephone screening, a screening visit, baseline visit, six intervention visits (once per week for six weeks), and one endpoint visit (one week after the final training visit). A telephone screening and screening visit will ensure participant eligibility. The screening visit included structured clinician interviews on PTSD symptoms and other mental health disorders, completion of questionnaires, and receipt of home saliva collection kit. At the baseline visit, electrodes will be attached to measure the electrical activity of head, chest, skin, and respiration and blood pressure during a computer task. Intervention visits include slow breathing, meditation, mediation and slow breathing, or sitting quietly depending on which group the participant is allocated to. Breathing rates and other electrical activity of the body will be measured also. Breathing rate will be measured with an elastic band that is placed around the chest. Electrical activity will be measured by the electrodes that will be placed on the scalp, chest and skin. The endpoint visit will be exactly the same as the baseline visit.
- Conditions
- Post-Traumatic Stress Disorders
- Being tested
- Slow Breathing, Meditation, Meditation and slow breathing, Sitting Quietly
- 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.
Slow BreathingBehavioural
The slowed breathing group will be trained on a breathing device, RESPeRATE, designed to reduce respiratory rate.They will practice with RESPeRATE once a week (for 6 weeks) in the laboratory with the research staff.
MeditationBehavioural
The Mindfulness Body Scan meditation will be used for the mindfulness meditation group.Participants will be trained once a week (for six weeks) in the laboratory by the research staff.
Meditation and slow breathingBehavioural
A structured Mindfulness breathing will be guided by the research staff during the lab trainings. The participant will sit upright and attempt to focus attention on his or her own breath as it passes the opening of the nostrils or on the rising and falling of the abdomen or chest. Whenever attention wanders from the breath, the participant will simply notice the distracting thought and then let it go as attention is returned to the breath. Training will be given once every week for 6 weeks.
Sitting QuietlyBehavioural
The SQ control group's "intervention" will include sitting quietly and listening to a neutral-content book on tape to serve as a time and attention control at each laboratory session. They will also be asked to sit quietly at home daily.
| Study group | Role | What they receive |
|---|---|---|
| Slow Breathing Group | Experimental | Not described Receives: Behavioral: Slow Breathing |
| Meditation Group | Experimental | Not described Receives: Behavioral: Meditation |
| Meditation and Slow Breathing Group | Experimental | Not described Receives: Behavioral: Meditation and slow breathing |
| Sitting Quietly Group | Placebo comparator | Not described Receives: Behavioral: Sitting Quietly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional Network Task: conflict effect score
Measured: Change from Baseline to Endpoint visit (one week after last training visit)
Awakening cortisol values
Measured: Change from Baseline to Endpoint visit (one week after last training visit)
Post-traumatic stress disorder checklist-hyperarousal score
Measured: Change from Baseline to Endpoint visit (one week after last training visit)
Secondary outcomes (3)
Intrusive Thought Scale
Measured: Change from Baseline to Endpoint visit (one week after last training visit)
EEG event-related negativity during Attentional Network Task
Measured: Change from Baseline to Endpoint visit (one week after last training visit)
Heart rate
Measured: Change from Baseline to Endpoint visit (one week after last training visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute
- Responsible party
- Principal investigator, Helane Wahbeh, Oregon Health and Science University
- Investigators
- Helane Wahbeh, ND, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778960
- Sponsor's protocol ID
- K01AT004951-01
- Other IDs
- K01AT004951-01, 4692
- Status last verified
- Jul 2015
- First submitted
- 22 Oct 2008
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
- ClinicalTrials.gov ID
- NCT00778960
- Acronym / sponsor ID
- K01AT004951-01
- Conditions
- Post-Traumatic Stress Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute
- Study start
- Jan 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Oct 2008 (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 purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms.
Detailed description
This study requires nine visits to the clinic: one screening visit, one baseline visit, six training sessions, and one endpoint visit. There will be approximately 100 people enrolled in this study who will be randomly allocated to one of four groups: a slow breathing group, a meditation group, a meditation plus slow breathing group and a sitting quietly group.
Participants will undergo a telephone screening, a screening visit, baseline visit, six intervention visits (once per week for six weeks), and one endpoint visit (one week after the final training visit). A telephone screening and screening visit will ensure participant eligibility. The screening visit included structured clinician interviews on PTSD symptoms and other mental health disorders, completion of questionnaires, and receipt of home saliva collection kit. At the baseline visit, electrodes will be attached to measure the electrical activity of head, chest, skin, and respiration and blood pressure during a computer task. Intervention visits include slow breathing, meditation, mediation and slow breathing, or sitting quietly depending on which group the participant is allocated to. Breathing rates and other electrical activity of the body will be measured also. Breathing rate will be measured with an elastic band that is placed around the chest. Electrical activity will be measured by the electrodes that will be placed on the scalp, chest and skin. The endpoint visit will be exactly the same as the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Slow Breathing Group | Experimental | Behavioral: Slow Breathing |
| Meditation Group | Experimental | Behavioral: Meditation |
| Meditation and Slow Breathing Group | Experimental | Behavioral: Meditation and slow breathing |
| Sitting Quietly Group | Placebo comparator | Behavioral: Sitting Quietly |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Combat veteran (defined by a score of ≥7 on the Combat exposure scale)
- Chronic PTSD diagnosis
- Age range (25-65 years)
- Both genders
- Good general medical health
Key exclusion criteria (22 listed)
- current cancer treatment,
- unstable angina,
- recent myocardial infarction,
- current or past history of stroke,
- transient ischemic attack,
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 |
|---|---|---|
| Slow BreathingThe slowed breathing group will be trained on a breathing device, RESPeRATE, designed to reduce respiratory rate.They will practice with RESPeRATE once a week (for 6 weeks) in the laboratory with the research staff. | Behavioural | Slow Breathing Group |
| MeditationThe Mindfulness Body Scan meditation will be used for the mindfulness meditation group.Participants will be trained once a week (for six weeks) in the laboratory by the research staff. | Behavioural | Meditation Group |
| Meditation and slow breathingA structured Mindfulness breathing will be guided by the research staff during the lab trainings. The participant will sit upright and attempt to focus attention on his or her own breath as it passes the opening of the nostrils or on the rising and falling of the abdomen or chest. Whenever attention wanders from the breath, the participant will simply notice the distracting thought and then let it go as attention is returned to the breath. Training will be given once every week for 6 weeks. | Behavioural | Meditation and Slow Breathing Group |
| Sitting QuietlyThe SQ control group's "intervention" will include sitting quietly and listening to a neutral-content book on tape to serve as a time and attention control at each laboratory session. They will also be asked to sit quietly at home daily. | Behavioural | Sitting Quietly Group |
Primary outcome
Attentional Network Task: conflict effect score
Time frame: Change from Baseline to Endpoint visit (one week after last training visit)
Awakening cortisol values
Time frame: Change from Baseline to Endpoint visit (one week after last training visit)
Post-traumatic stress disorder checklist-hyperarousal score
Time frame: Change from Baseline to Endpoint visit (one week after last training visit)
3 secondary outcomes
Intrusive Thought Scale
Time frame: Change from Baseline to Endpoint visit (one week after last training visit)
EEG event-related negativity during Attentional Network Task
Time frame: Change from Baseline to Endpoint visit (one week after last training visit)
Heart rate
Time frame: Change from Baseline to Endpoint visit (one week after last training visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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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.
Helane Wahbeh, ND principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Breathing, Meditation and Meditation and slow breathing in people with Post-Traumatic Stress Disorders, run by Oregon Health and Science University 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 7 inclusion and 22 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 13 Jul 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Attentional Network Task: conflict effect score (time frame: Change from Baseline to Endpoint visit (one week after last training visit)). 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 13 Jul 2015.