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

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01419223
First received: August 16, 2011
Last updated: October 25, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: July 2011
Study Completion Date: September 2013
Primary Completion Date: September 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419223

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
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: October 25, 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
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 26, 2014