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OpenTrials
Completed

NCT Number: NCT01419223

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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 outcomes

  1. 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

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

Sponsors and collaborators

Lead sponsor

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 18, 2011
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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