Clinical trial NCT01419223: Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)
Official title: Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Traumatic Stress Disorder
Brain Injuries, Traumatic
Keywords: Qualitative research
Health Knowledge, Attitudes, Practice
Refusal to Participate
Lead sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2011-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active military and/or veterans ages 18 or over who have recently considered participating in an outpatient clinical trial for PTSD or TBI.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Perceptions about participation in clinical trials for PTSD or TBI as measured via qualitative interview.
timeFrame: 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.
Secondary outcomes:
measure: 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.
timeFrame: End of 21-month study recruitment period
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Samantha Hurst, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: