An observational study in Post-Traumatic Stress Disorder and Brain Injuries, Traumatic, sponsored by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-29.
Sponsored by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Observational
This is an exploratory qualitative interview study being conducted with a primary objective of examining perceptions held by active military and veterans regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI) clinical trials. Active duty military and/or veterans aged 18 years and older who consent to participate (N = 50), or have recently declined participation (N = 50), in an INTRuST affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited. Participants who consent to participate in an INTRuST clinical trial (Group 1) will be interviewed once at the beginning the of the clinical trial, and again following participation in the trial. Participants who decline participation in an INTRuST affiliated outpatient clinical trial (Group 2) will be interviewed once. For participants in both groups, study participation will initiate within 1 month of referral to study. Total duration of study participation is based on the specific clinical trial that the participant is recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured qualitative individual interviews will be conducted to carry out a thematic analysis of the data exploring familial, social and institution-level constructs which may influence the subjective experience of the research treatment process.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Active military and/or veterans ages 18 or over who have recently considered participating in an outpatient clinical trial for PTSD or TBI.
Inclusion Criteria:
Active military and veterans who consent to participate in an INTRuST PTSD or TBI research trial.
Active military and veterans who decline to participate in an INTRuST PTSD or TBI research trial.
Perceptions about participation in clinical trials for PTSD or TBI as measured via qualitative interview.
Perceptions regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in clinical treatment trials for PTSD-TBI will be measured via serial qualitative interview framework.
Time frame: Qualitative interviews will be conducted during an expected average time frame of 12-24 weeks per study participant based on the specific study recruited from.
Feasibility of conducting qualitative interviews with active duty military and veterans who consent or decline participation in a PTSD or TBI clinical trial as measured by study participation.
Feasibility will be determined by the number of participants anticipated vs. the number actually enrolled in the current study.
Time frame: End of 21-month study recruitment period
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium