Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings

NCT00974402 | Completed DMC

• 3 other identifiers: HSC20090194HBAMC C.2009.022W81XWH-08-2-0109
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral health consultants working with Service Members in the primary care clinic. CBT is a well-researched, very effective individual (one-to-one) treatment that is designed to help people to directly deal with traumatic events they have suffered in the past, including combat. Many Service Members prefer to see behavioral health providers in primary care rather than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in primary care can be just as useful as more traditional treatment given in the mental health clinic. This study will enroll approximately 45 participants overall; with approximately 30 participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15 participants to be enrolled at the South Texas Veterans Health Care System over a period of one year.

Conditions

Post-Traumatic Stress Disorders; Stress Disorders; Combat Disorders

Keywords

Active duty; Afghanistan; Anger; Anxiety; Avoidance; BAMC; Brooke Army Medical Center; Cognitive Behavioral Therapy; Combat; Combat Disorder; Coping; Counseling; Counselor; Deployment; Depression; Exposure; Fear; Feeling alone; Flashbacks; Guard; Guilt; Hospitalization; Iraq; Mental Health; Military; Military member; Military personnel; Neuroses; Nightmares; OEF; OIF; Prolonged Exposure Therapy; Psychiatric; Psychiatric medication; Psychological distress; Psychotherapy; Reserve; Retired; Sadness; Separated; Sleeplessness; Soldier; Stress; Stress disorder; Stress management; STRONG STAR; Suicidal; Suicide; Therapy; Trauma; Traumatic Event; Trouble Sleeping; Veteran; Veterans; War; WHMC; Wilford Hall Medical Center; PTSD; Posttraumatic Stress Disorders

Outcome Measures

Primary Outcomes (1)

• PTSD symptomatology

  PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).

  Baseline, post-treatment, 6-month and 12-month

Study Arms (1)

Patients with PTSD Symptoms

EXPERIMENTAL

Patients with Post-Traumatic Stress Disorder (PTSD) symptoms willing to undergo Cognitive Behavioral Therapy in a primary care setting.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

The study investigators have developed a 4-session PTSD treatment plan including a behavioral health consultants (BHC) manual and a patient guide for use in primary care. Therapists will be psychologists who are functioning as behavioral health consultants (BHC) in an integrated primary care clinic. The study will adapt intervention methods for use in the time-constrained primary care environment from Cognitive Behavioral Therapy(ies) that have proven effective for PTSD in specialty mental health care settings. Study participants will receive four 30-minute treatment sessions over six weeks.

Also known as: brief cognitive-behavioral therapy (CBT)

Patients with PTSD Symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The target population for the study is active duty, reserve, guard, separated, or retired OIF/OEF veterans (minimum age 18 and English speaking) in the primary care population who are symptomatic for deployment-related PTSD and interested in treatment.
• Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList - Military (PCL-M).

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Brooke Army Medical Center: collaborator
• 59th Medical Wing: collaborator
• South Texas Veterans Health Care System: collaborator

Study Sites (3)

South Texas Veterans Health Care System (STVHCS)

San Antonio, Texas, 78229, United States

Location

Brooke Army Medical Center (BAMC)

San Antonio, Texas, 78234-6200, United States

Location

Wilford Hall Medical Center

San Antonio, Texas, 78236-5300, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Combat Disorders; Anxiety Disorders; Depression; Psychological Well-Being; Neurotic Disorders; Sleep Initiation and Maintenance Disorders; Suicide; Wounds and Injuries; Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alan L Peterson, PhD

  University of Texas Health Science Center San Antonio (UTHSCSA), STRONG STAR Consortium Director

  STUDY CHAIR

• Jeffrey Cigrang, Lt Col

  U.S. Air Force, 5MDG, Minot Air Force Base

  PRINCIPAL INVESTIGATOR

• Lisa Kearney, PhD

  South Texas Veterans Health Care System (STVHCS)

  PRINCIPAL INVESTIGATOR

• Diana Dolan, Capt

  U.S. Air Force, Wilford Hall Medical Center (WHMC)

  PRINCIPAL INVESTIGATOR

• Laura Avila, PhD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: March 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (3)