Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)
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Purpose
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.
| Condition |
|---|
|
Post-Traumatic Stress Disorder Brain Injuries, Traumatic |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
Inclusion Criteria:
- Age between 18 and over
- Active duty and/or veteran
- Referred to participate in INTRuST-affiliated outpatient clinical trials for PTSD or TBI
- Ability to provide written informed consent
Contacts and Locations| Contact: Samantha Hurst, Ph.D. | (858) 246-0634 | shurst@ucsd.edu |
| United States, California | |
| University of California San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Principal Investigator: | Samantha Hurst, Ph.D. | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium |
| ClinicalTrials.gov Identifier: | NCT01419223 History of Changes |
| Other Study ID Numbers: | INTRuST- Beliefs and Attitudes |
| Study First Received: | August 16, 2011 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
|
Qualitative research Health Knowledge, Attitudes, Practice Refusal to Participate |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Brain Injuries Anxiety Disorders Mental Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013