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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00635635

Collaborator

National Institutes of Health (NIH) (NIH), Durham VA Medical Center (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorder, Post Traumatic Military Sexual Trauma	Behavioral: Guided Imagery Audio Behavioral: Music Audio	N/A

Detailed Description

Study Aims: The primary aims of this study are: (1) To determine the efficacy of the GIFT intervention for women veterans with MST-related PTSD. (2) To determine the effects of GIFT on mental health and health services utilization, and neurobiological outcomes. (3) To identify predictors of GIFT treatment outcomes.

Research Plan: We will conduct a 12-week randomized, controlled trial of GIFT in 38 women veterans with MST-related PTSD. Half will be randomly assigned to GIFT and half to a music control group. GIFT includes a pretreatment orientation and midpoint consultation session with a clinician facilitator, a guided imagery audio, daily self-monitoring of audio use, and weekly telephone coaching calls with the facilitator. The music control condition is designed to control for all nonspecific aspects of GIFT and matches the GIFT protocol in all ways but the two specific "ingredients" through which GIFT is hypothesized to have its effect: (1) the guided imagery audio, and (2) the facilitator's help in structuring and focusing use of the guided imagery audio. Thus, the key differences between the two groups are that controls will receive an audio of the relaxing background music used on the guided imagery audio, but not the guided imagery exercises, and controls' contacts with the facilitator is limited to psychoeducational information and general support, and will not include help in structuring and focusing use of the audio, which is a key component of GIFT.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Guided Imagery for Military Sexual Trauma-Related PTSD

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Guided Imagery Audio	Behavioral: Guided Imagery Audio Guided Imagery Audio listened to 5x per week
Active Comparator: 2 Music Audio	Behavioral: Music Audio Music only audio to be listened to 5x per week

Arm

Intervention/Treatment

Active Comparator: 1

Guided Imagery Audio

Behavioral: Guided Imagery Audio

Guided Imagery Audio listened to 5x per week

Active Comparator: 2

Music Audio

Behavioral: Music Audio

Music only audio to be listened to 5x per week

Outcome Measures

Primary Outcome Measures

PTSD Severity - Clinician Administered PTSD Scale (CAPS) [Midpoint and Endpoint]

Secondary Outcome Measures

Neuroactive Steroid assay [Endpoint]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.