Guided Imagery for Military Sexual Trauma-Related Posttraumatic Stress Disorder (PTSD)

NCT00635635 | Completed

• 1 other identifier: Pro00001282
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Military sexual trauma (MST) is a significant women's mental health issue. There is a crucial need for effective therapies for MST-related posttraumatic stress disorder (PTSD) that are well-tolerated and can be flexibly administered in a variety of treatment settings. Guided imagery is a novel, transportable intervention technique that meets these requirements and warrants research in PTSD. The proposed study will be a randomized controlled trial of the Guided Imagery for Trauma (GIFT) intervention for women veterans with MST-related PTSD. This minimal contact intervention is designed to increase coping, affect management and relaxation skills, and to fostering more positive images and beliefs associated with surviving trauma. The feasibility and tolerability of GIFT have already been demonstrated in an open-label pilot of 15 women veterans with MST-related PTSD, with very promising initial results.

Conditions

Stress Disorder, Post Traumatic; Military Sexual Trauma

Keywords

Stress Disorders, Post-Traumatic; Anxiety,; Depression,; Guided Imagery; Military Sexual Trauma

Outcome Measures

Primary Outcomes (1)

• PTSD Severity - Clinician Administered PTSD Scale (CAPS)

  Midpoint and Endpoint

Secondary Outcomes (1)

• Neuroactive Steroid assay

  Endpoint

Study Arms (2)

1

ACTIVE COMPARATOR

Guided Imagery Audio

Behavioral: Guided Imagery Audio

2

ACTIVE COMPARATOR

Music Audio

Behavioral: Music Audio

Interventions

Guided Imagery Audio BEHAVIORAL

Guided Imagery Audio listened to 5x per week

1

Music Audio BEHAVIORAL

Music only audio to be listened to 5x per week

2

Eligibility Criteria

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

You may qualify if:

• Age 18-65
• Status as a women veteran
• Receives care at the Durham VAMC
• History of MST, confirmed by CAPS interview
• DSM-IV diagnosis of PTSD, confirmed by CAPS interview
• Able to participate in a research interview in English.
• Regular telephone access

You may not qualify if:

• Current diagnosis of organic, psychotic, or bipolar disorder
• Suicidality or parasuicidality
• Ongoing family violence
• Alcohol or drug abuse within previous 3 months
• Enrolled in cognitive-behavioral/exposure-based therapy for PTSD during study period. Supportive therapy and some psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable. Although patients may use medications, no new medications will be started during the study. This includes, but is not restricted to, SSRIs, benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, non-benzodiazepine hypnotics, stimulants, or antipsychotics.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• Durham VA Medical Center: collaborator

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Military Sexual Trauma; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sexual Trauma; Behavioral Symptoms; Behavior

Study Officials

• Jennifer L Strauss, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2008
• First Posted: March 14, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

US (1)