NCT01605799

Brief Summary

The goals of this project are

  • 1\) to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone,
  • 2\) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further refine the intervention, and
  • 3\) to gather data on clinician stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to ensure that the module could be easily integrated into EBT for PTSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

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

May 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed
Last Updated

February 23, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

May 18, 2012

Results QC Date

November 13, 2015

Last Update Submit

January 22, 2016

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDMental HealthWarVeterans

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD Symptoms as Measured by the PCL

    The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).

    PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)

Secondary Outcomes (1)

  • Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)

    The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)

Study Arms (2)

IOK Treatment

ACTIVE COMPARATOR

Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.

Behavioral: IOK Killing Treatment

Wait list control group

PLACEBO COMPARATOR

Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.

Behavioral: IOK Killing TreatmentBehavioral: Wait list control group

Interventions

IOK Killing TreatmentBEHAVIORAL

The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.

IOK TreatmentWait list control group
Wait list control groupBEHAVIORAL

Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.

Wait list control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Combat Veterans ranging in age from 18-70 years will be recruited to participate in this study. Combat veterans ranging in age from 70 to 90 years will also be considered for enrollment in the study on a case-by-case basis.
  • Veterans will need to endorse having taken a life in a war zone context, to meet criteria for PTSD, and to have received some prior treatment for PTSD to be included in the study.
  • Participants in current PTSD treatment will not be excluded; however, if receiving medications, they will need to be stabilized on current medications for at least one month.
  • If receiving Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), the two treatments the VA recognizes as evidence-based treatment for PTSD, individuals will need to wait two weeks after they have completed the treatment in order to enroll in the study, and new baseline measures will be obtained at that time.

You may not qualify if:

  • Potential participants will only be excluded if they meet current or lifetime criteria for a psychotic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (1)

  • Maguen S, Burkman K. Combat-Related Killing: Expanding Evidence-Based Treatments for PTSD. Cognitive and behavioral practice. 2013 Nov 1; 20(4):476-479.

    RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPsychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal SatisfactionBehavior

Results Point of Contact

Title
Dr. Shira Maguen
Organization
San Francisco VA Medical Center
shira.maguen@va.gov
415-221-4810

Study Officials

  • Shira Maguen, PhD

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 25, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 23, 2016

Results First Posted

December 17, 2015

Record last verified: 2016-01

Locations

US(1)