Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)
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.
Post-Traumatic Stress Disorder
Brain Injuries, Traumatic
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials|
- Perceptions about participation in clinical trials for PTSD or TBI as measured via qualitative interview. [ 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. ] [ Designated as safety issue: No ]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.
- 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. [ Time Frame: End of 21-month study recruitment period ] [ Designated as safety issue: No ]Feasibility will be determined by the number of participants anticipated vs. the number actually enrolled in the current study.
|Study Start Date:||July 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Consent to participate (Group 1)
Active military and veterans who consent to participate in an INTRuST PTSD or TBI research trial.
Decline to participate (Group 2)
Active military and veterans who decline to participate in an INTRuST PTSD or TBI research trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419223
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Samantha Hurst, Ph.D.||University of California, San Diego|