Posttraumatic Stress DisorderNCT01607632
Loving-kindness Meditation for Posttraumatic Stress Disorder (PTSD)
A study testing loving-kindness meditation in people with Posttraumatic Stress Disorder, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- loving-kindness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- posttraumatic stress disorder
Who cannot join
- psychosis
- borderline personality disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Pilot Study of Loving-Kindness Meditation for PTSD
A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- loving-kindness meditation
- Keywords
- posttraumatic stress, depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loving-kindness meditationBehavioural
A 12-week duration, 90 minute per session loving-kindness meditation course
| Study group | Role | What they receive |
|---|---|---|
| loving-kindness meditation | Experimental | Not described Receives: Behavioral: loving-kindness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PTSD symptoms
The PTSD symptom-scale interview was performed
Measured: baseline, post-intervention, 3-month follow-up
change in depressive symptoms
The PROMIS measure for depression was administered
Measured: baseline, post-intervention, 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 posted30 May 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kearney, Seattle Institute for Biomedical and Clinical Research
- Investigators
- David Kearney, MD, Principal investigator, VA Puget Sound
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607632
- Sponsor's protocol ID
- 00173
- Status last verified
- May 2012
- First submitted
- 23 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Pilot Study of Loving-Kindness Meditation for PTSD
- ClinicalTrials.gov ID
- NCT01607632
- Acronym / sponsor ID
- 00173
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 May 2012 (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.
A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| loving-kindness meditation | Experimental | Behavioral: loving-kindness meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- posttraumatic stress disorder
Key exclusion criteria (2 listed)
- psychosis
- borderline personality disorder
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 |
|---|---|---|
| loving-kindness meditationA 12-week duration, 90 minute per session loving-kindness meditation course | Behavioural | loving-kindness meditation |
Primary outcome
change in PTSD symptoms
Time frame: baseline, post-intervention, 3-month follow-up
The PTSD symptom-scale interview was performed
change in depressive symptoms
Time frame: baseline, post-intervention, 3-month follow-up
The PROMIS measure for depression was administered
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 30 May 2012.
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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.
David Kearney, MD principal investigator
VA Puget Sound
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing loving-kindness meditation in people with Posttraumatic Stress Disorder, run by Seattle Institute for Biomedical and Clinical Research 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 1 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 30 May 2012. 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 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?
change in PTSD symptoms (time frame: baseline, post-intervention, 3-month follow-up). 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 30 May 2012.