NCT01627548

Brief Summary

A pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

June 21, 2012

Last Update Submit

October 31, 2022

Conditions

Keywords

PTSDCouplesCombat VeteranWarfighterOEFOIFONDStructured Approach TherapyTrauma

Outcome Measures

Primary Outcomes (1)

  • Improved couples communication as measured by standardized assessments

    4-6 months

Study Arms (2)

Waitlisted Intervention

ACTIVE COMPARATOR

Couple will be consented, assessed and randomized to a waitlist of 4 months. The couple will be reassessed at 8 weeks and prior to initiating intervention.

Behavioral: Structured Approach Therapy

Immediate Intervention

ACTIVE COMPARATOR

Eligible couples who are randomized to immediate intervention will begin sessions with a trained interventionist within weeks of consent and initial assessments

Behavioral: Structured Approach Therapy

Interventions

The SAT treatment is provided in 12 weekly 50-minute sessions and is fully manualized. First, couple-based exposure techniques are used to address anxiety about intimacy, increasing the traumatized person's ability to engage in social and relational behaviors that promote bonding and satisfaction. Second, as anxiety decreases, couple-based techniques are also used to increase the positive experiences the couple is having. These activities expose the traumatized person to positive feelings instead of anxiety, so that he/she may become desensitized to the anxiety caused by the closeness, and more comfortable engaging in intimate behaviors.

Immediate InterventionWaitlisted Intervention

Eligibility Criteria

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

You may qualify if:

  • OIF/OEF/ OND veteran with at least one deployment
  • In a cohabitating relationship for 6 months or longer
  • Cohabitating 50% of the time or more
  • Diagnosed with PTSD or meets the diagnosis criteria for PTSD as related to deployment experience (CAPS)
  • Ability to make weekly appointments
  • Willingness to commit to change

You may not qualify if:

  • Receiving an evidence-based treatment for PTSD within the past 6 months
  • Receiving couples therapy within the last 6 months
  • Moderate or excessive physical violence within the past 3 months (CTS)
  • Alcohol/substance dependence (SCID)
  • Known domestic violence/abuse (CTS)
  • Symptoms of psychosis within the past 3 months
  • Unstable psychiatric medicine usage or on regimen less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Shrley M Glynn, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Patricia E Lester, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Researcher

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 3, 2022

Record last verified: 2022-10

Locations