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

NCT ID: NCT01419223

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Post-Traumatic Stress Disorder Brain Injuries, Traumatic

Keywords

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Qualitative research Health Knowledge, Attitudes, Practice Refusal to Participate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Consent to participate (Group 1)

Active military and veterans who consent to participate in an INTRuST PTSD or TBI research trial.

No interventions assigned to this group

Decline to participate (Group 2)

Active military and veterans who decline to participate in an INTRuST PTSD or TBI research trial.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samantha Hurst, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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INTRuST- Beliefs and Attitudes

Identifier Type: -

Identifier Source: org_study_id