Posttraumatic Stress DisorderPhase 1NCT01581983
Mindfulness Meditation Format Pilot Study
A Phase 1 study testing Internet Mindfulness Meditation and Individual Mindfulness Meditation in people with Posttraumatic Stress Disorder and Depression, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Internet Mindfulness Meditation and Individual Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2015
- Phase
- Phase 1
- 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
- Good general health
- Age 25-65
- Access to internet
- PTSD symptoms (score >14 on PTSD screen)
- Depression symptoms (endorsement of one question on depression screen)
- Stable on medications six weeks prior to the study
- Willing to be stable on medications during study
Who cannot join
- Significant potentially life-limiting acute medical illness
- Risk for suicide
- >2 drinks/day of alcohol and street drug use besides marijuana
- Current daily meditation practice
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms
Read the detailed description
Internet and individual formats of mindfulness meditation have not been previously evaluated. In order establish feasibility of such formats a pilot study is need. The current study will randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and depression symptoms from before to after the internet and individual mindfulness meditation interventions.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Internet Mindfulness Meditation, Individual Mindfulness Meditation
- 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.
Internet Mindfulness MeditationBehavioural
one hour session each week for six weeks
Individual Mindfulness MeditationBehavioural
one hour session each week for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Internet Mindfulness Meditation | Experimental | Not described Receives: Behavioral: Internet Mindfulness Meditation |
| Individual Mindfulness Meditation | Experimental | Not described Receives: Behavioral: Individual Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist
The Posttraumatic Stress Disorder Checklist will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7.
Measured: Change from baseline to week 7.
Beck Depression Inventory
The Beck Depression Inventory will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7.
Measured: Change from Baseline to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2015
- Study completionJun 2015
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helane Wahbeh, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581983
- Sponsor's protocol ID
- IRB00008355
- Status last verified
- Jul 2015
- First submitted
- 7 Apr 2012
- Last updated
- 13 Jul 2015
- Results posted
- 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
- Mindfulness Meditation Format Pilot Study
- ClinicalTrials.gov ID
- NCT01581983
- Acronym / sponsor ID
- IRB00008355
- Conditions
- Posttraumatic Stress Disorder, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Apr 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.
The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms
Detailed description
Internet and individual formats of mindfulness meditation have not been previously evaluated. In order establish feasibility of such formats a pilot study is need. The current study will randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and depression symptoms from before to after the internet and individual mindfulness meditation interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Mindfulness Meditation | Experimental | Behavioral: Internet Mindfulness Meditation |
| Individual Mindfulness Meditation | Experimental | Behavioral: Individual Mindfulness Meditation |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Good general health
- Age 25-65
- Access to internet
- PTSD symptoms (score >14 on PTSD screen)
- Depression symptoms (endorsement of one question on depression screen)
Key exclusion criteria (4 listed)
- Significant potentially life-limiting acute medical illness
- Risk for suicide
- >2 drinks/day of alcohol and street drug use besides marijuana
- Current daily meditation practice
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 |
|---|---|---|
| Internet Mindfulness Meditationone hour session each week for six weeks | Behavioural | Internet Mindfulness Meditation |
| Individual Mindfulness Meditationone hour session each week for six weeks | Behavioural | Individual Mindfulness Meditation |
Primary outcome
Posttraumatic Stress Disorder Checklist
Time frame: Change from baseline to week 7.
The Posttraumatic Stress Disorder Checklist will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7.
Beck Depression Inventory
Time frame: Change from Baseline to Week 7
The Beck Depression Inventory will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Internet Mindfulness Meditation and Individual Mindfulness Meditation in people with Posttraumatic Stress Disorder and Depression, 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 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Posttraumatic Stress Disorder Checklist (time frame: Change from baseline to week 7.). 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 13 Jul 2015.