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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01419223

Enrollment

Registered

2011-08-18

Start date

2011-07-31

Completion date

2013-09-30

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic, Post-Traumatic Stress Disorder

Keywords

Qualitative research, Health Knowledge, Attitudes, Practice, Refusal to Participate

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Perceptions about participation in clinical trials for PTSD or TBI as measured via qualitative interview.	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.	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.

Secondary

Measure	Time frame	Description
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	Feasibility will be determined by the number of participants anticipated vs. the number actually enrolled in the current study.

Countries

United States

Outcome results