NCT01419223|CompletedDMC
Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)
Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials
Loading search results
Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials
Sponsor study identifier
observational
30
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 16, 2011
Actual (reported)August 18, 2011
Actual (reported)September 2013
Actual (reported)September 2013
Actual (reported)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.
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.
End of 21-month study recruitment period
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.
Active military and/or veterans ages 18 or over who have recently considered participating in an outpatient clinical trial for PTSD or TBI.
University of California San Diego
La Jolla, California, 92093, United States
Samantha Hurst, Ph.D.
University of California, San Diego
30 participants (actual enrollment reported by the registry).
First Submitted
August 16, 2011
First Posted
August 18, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Structural and Functional Neuroimaging Studies of Combat Veterans
Contact the study team to confirm eligibility.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
October 29, 2013
Record last verified: 2013-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: