Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00635635
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2008-03-09
Brief Title:
Guided Imagery for Military Sexual Trauma-Related Posttraumatic Stress Disorder PTSD
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Guided Imagery for Military Sexual Trauma-Related PTSD
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Military sexual trauma MST is a significant womens 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
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 facilitators 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
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 facilitators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None