Study Stopped
Attempts to recruit eligible subjects revealed that it would not be possible to enroll adequate numbers. Thus- no subjects were enrolled.
Big Mind for Veterans With PTSD
A Pilot Study of Big Mind for Veterans With PTSD
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals experiencing mood and anxiety symptoms. The aim of this pilot study is to test the feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and other psychological symptoms. Big Mind is a method of self-exploration that utilizes a voice dialog technique to help individuals see the world and themselves from a variety of perspectives. The investigators hypothesize that this process will increase mindfulness and decrease self-referential thinking, which is associated with negative affect. To test the feasibility of using this method, veterans with PTSD will complete a four-week group Big Mind class with a total of four sessions. The investigators will use a single group design with pre and post-intervention measures to assess tolerability and acceptance of the intervention. Secondary outcome measures will evaluate symptom improvement and increased mindfulness. If this project demonstrates that using this intervention for veterans with PTSD is feasible, then more rigorous clinical trials will be warranted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 28, 2016
April 1, 2016
8 months
August 27, 2015
April 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility
The investigators will assess tolerability and acceptance of the intervention via subjective feedback from each participant at the end of week 4, and monitor drop out rates.
4 weeks
Secondary Outcomes (5)
Improvement of PTSD symptoms
4 weeks
Increase in mindfulness
4 weeks
Improvement of depressive symptoms
4 weeks
Improvement of anxiety
4 weeks
Improvement of sleep
4 weeks
Interventions
mindfulness based intervention
Eligibility Criteria
You may qualify if:
- male and female veterans with PTSD
- age 18 - 65
- ability to provide informed consent
You may not qualify if:
- diagnosis of any psychotic disorder
- psychotic symptoms secondary to a mood disorder or other condition
- diagnosis of cognitive impairment or dementia
- currently on facility suicide high-risk list
- pregnancy
- impaired decision-making capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George E. Whalen VAMC
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Physician
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 4, 2015
Study Start
August 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 28, 2016
Record last verified: 2016-04