NCT00374738

Brief Summary

Our specific aims are:

  1. 1.To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans
  2. 2.To examine the effects of GIFT on fronto-limbic brain function and
  3. 3.To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

September 7, 2006

Last Update Submit

May 10, 2016

Conditions

Stress Disorders

Keywords

Guided Imagery for Trauma (GIFT)Posttraumatic Stress Disorder (PTSD)Military Sexual Trauma (MST)Military Sexual Trauma - related PTSD

Study Arms (2)

GIFT Intervention

EXPERIMENTAL

Guided Imagery for Trauma (GIFT)

Behavioral: Guided Imagery for Trauma (GIFT)

Music Control

NO INTERVENTION

Relaxing Music Audio control; same music used in guided imagery, with no narrative voice.

Interventions

Guided Imagery for Trauma (GIFT)BEHAVIORAL

Guided Imagery for Trauma (GIFT) - music and voice narration over a 12-week intervention. The control intervention included a relaxing music audio (the same music used in the guided imagery audio but without the narrative voiceover), PDA to log audio use, orientation and weekly phone consults, but did not have access to the patient advocate or to the guided imagery instructions provided on the GIFT audio.

GIFT Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65
  • Status as a woman veteran
  • Receives care at the Durham VAMC
  • History of MST
  • 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 or psychotic mental disorder
  • Suicidality or parasuicidality
  • Ongoing family violence
  • Alcohol or drug dependence within previous 3 months
  • Enrolled in cognitive-behavioral/exposure-based therapy during study period.
  • Supportive therapy and psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable.
  • An uncontrolled medical condition
  • Foreign metallic objects or implanted devices in the body incompatible with MRI
  • Positive pregnancy test as determined by serum ß-HCG level
  • Claustrophobia
  • CNS neoplasms or neurological conditions such as Parkinson's Disease, Huntington's Chorea, demyelinating diseases, seizures, hydrocephalus, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Veterans' Comprehensive Health Center (WVCHC) @ Durham Veterans Affairs Medical Center (DVAMC)

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, TraumaticStress Disorders, Post-TraumaticMilitary Sexual Trauma

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersSexual Trauma

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jennifer L. Strauss, PhD

    Duke University Medical Center & Durham VA Medical Center

    PRINCIPAL INVESTIGATOR

  • Christine Marx, MD, MA

    Duke University Medical Center & Durham VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 11, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Study terminated/inactive.

Locations

US(1)