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

Study Overview
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Brief Summary
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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.

Official Title
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Patient Beliefs and Attitudes That Influence Participation in PTSD-TBI Clinical Trials

Conditions
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Post-Traumatic Stress Disorder, Brain Injuries, Traumatic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consent to participate (Group 1)<br>Active military and veterans who consent to participate in an INTRuST PTSD or TBI research trial. | |
| Decline to participate (Group 2)<br>Active military and veterans who decline to participate in an INTRuST PTSD or TBI research trial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Feasibility will be determined by the number of participants anticipated vs. the number actually enrolled in the current study. | End of 21-month study recruitment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qualitative research, Health Knowledge, Attitudes, Practice, Refusal to Participate