NCT00669981

Brief Summary

This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2008

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

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

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

3.8 years

First QC Date

April 29, 2008

Last Update Submit

November 22, 2013

Conditions

Post-traumatic Stress Disorder

Keywords

PTSDRelationship DistressCouple Therapy

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered PTSD Scale

    Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up

Secondary Outcomes (1)

  • Dyadic Adjustment Scale

    Measured at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive immediate cognitive behavioral couples therapy for PTSD.

Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)

2

ACTIVE COMPARATOR

Participants will receive delayed cognitive behavioral couples therapy for PTSD after a 3-month waitlist period.

Behavioral: Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)

Interventions

Cognitive behavioral couples therapy for post-traumatic stress disorder (CBCT for PTSD)BEHAVIORAL

CBCT for PTSD is a 15-session manualized couples therapy that aims to both decrease individual PTSD symptoms and improve dyadic functioning.

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current diagnosis of PTSD
  • An intimate partner willing to participate in treatment

You may not qualify if:

  • Both partners have PTSD
  • Either partner with substance dependence not in remission for at least 3 months before study entry, current uncontrolled bipolar or psychotic disorder, or severe cognitive impairment
  • Couple currently experiencing severe intimate aggression or a desire to separate or end their intimate relationship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (3)

  • Monson CM, Schnurr PP, Stevens SP, Guthrie KA. Cognitive-Behavioral Couple's Treatment for posttraumatic stress disorder: initial findings. J Trauma Stress. 2004 Aug;17(4):341-4. doi: 10.1023/B:JOTS.0000038483.69570.5b.

    PMID: 15462542BACKGROUND

  • Monson CM, Fredman SJ, Adair KC. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: application to operation enduring and Iraqi Freedom veterans. J Clin Psychol. 2008 Aug;64(8):958-71. doi: 10.1002/jclp.20511.

    PMID: 18613094BACKGROUND

  • Monson CM, Fredman SJ, Macdonald A, Pukay-Martin ND, Resick PA, Schnurr PP. Effect of cognitive-behavioral couple therapy for PTSD: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):700-9. doi: 10.1001/jama.2012.9307.

    PMID: 22893167DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Candice M. Monson, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Director of Clinical Training

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

US(1)CA(1)