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Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)

This study is currently recruiting participants.
Verified April 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01419223
First received: August 16, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes

August 16, 2011
April 24, 2013
July 2011
June 2013   (final data collection date for primary outcome measure)
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.
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 weeks per study participant ] [ 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.
Complete list of historical versions of study NCT01419223 on ClinicalTrials.gov Archive Site
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.
Same as current
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Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)
Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials

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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Active military and/or veterans ages 18 or over who have recently considered participating in an outpatient clinical trial for PTSD or TBI.
  • Post-Traumatic Stress Disorder
  • Brain Injuries, Traumatic
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age between 18 and over
  2. Active duty and/or veteran
  3. Referred to participate in INTRuST-affiliated outpatient clinical trials for PTSD or TBI
  4. Ability to provide written informed consent
Both
18 Years and older
No
Contact: Samantha Hurst, Ph.D. (858) 246-0634 shurst@ucsd.edu
United States
 
NCT01419223
INTRuST- Beliefs and Attitudes
Yes
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Principal Investigator: Samantha Hurst, Ph.D. University of California, San Diego
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP