NCT02069873

Brief Summary

The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of evidence-based therapies in comparison to a wait-list control and evaluate the relative contribution of exposure, cognitive, and skills blocks of treatment in a 16-session manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1: Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD symptoms than the skills component. Significant results will establish the efficacy of a group format for evidence-based treatments for all veterans with a PTSD diagnosis. An ancillary part of the study is to examine initial neuropsychological presentation in this population and possible changes that may occur as the result of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 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

Study Start

First participant enrolled

April 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

4.8 years

First QC Date

February 14, 2014

Last Update Submit

February 20, 2014

Conditions

Post Traumatic Stress Disorder

Keywords

Post Traumatic Stress DisorderGroupTreatmentCognitive, Exposure, SkillsWomenVeterans

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.

    Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD).

    Baseline, post-treatment, 3 months follow up, 6 months follow up.

Secondary Outcomes (3)

  • Change in mental and physical functioning from baseline on the Health Related Quality of Life (SF36) to post-treatment, 3 months, and 6 months later.

    Baseline, post-treatment, 3-month follow up, 6-month follow up

  • Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later.

    Baseline, post-treatment, 3-month follow up, 6-month follow up

  • Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL).

    Baseline, after each treatment block (every 5 weeks), post-treatment

Study Arms (2)

16-Week Group Treatment

EXPERIMENTAL

The 16-week treatment group will contain 3 blocks of treatment (exposure, cognitive, skills) with order randomized within the treatment. The first and last group session are considered inactive treatment sessions. The group treatment will be provided weekly.

Behavioral: 16-Week Group Treatment

Wait List Control

NO INTERVENTION

The Wait List Control group will receive minimal attention, as they will meet bi-monthly for supportive sessions with the study psychologist. The study psychologist will not introduce any active treatment in the individual sessions.

Interventions

16-Week Group TreatmentBEHAVIORAL

Within the 16-week group treatment, the cognitive block will contain 5 sessions, the exposure block will contain 5 sessions, and the skills block will contain 4 sessions.

Also known as: Cognitive treatment, Exposure treatment, Skills treatment, Group treatment
16-Week Group Treatment

Eligibility Criteria

Age19 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of PTSD
  • Iraq or Afghanistan female Veteran
  • Psychiatry stability (no suicide, homicide)
  • One clear memory of a trauma
  • Stability on psychiatric medications for 1 month

You may not qualify if:

  • Active substance use/abuse (or in remission less than 3 mo)
  • Psychotic symptoms or diagnosis
  • Bipolar disorder diagnosis
  • Cognitive impairment
  • Involvement in a violent relationship
  • Self mutilation within past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

Location

Related Publications (9)

  • Foa EB, Rothbaum BO, Riggs DS, Murdock TB. Treatment of posttraumatic stress disorder in rape victims: a comparison between cognitive-behavioral procedures and counseling. J Consult Clin Psychol. 1991 Oct;59(5):715-23. doi: 10.1037//0022-006x.59.5.715.

    PMID: 1955605BACKGROUND

  • Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.

    PMID: 17327524BACKGROUND

  • Keane TM , Fairbank JA , Caddell JM , Zimering RT : Implosive (flooding) therapy reduces symptoms of PTSD in Vietnam combat Veterans . Behav Ther 1989 ; 20: 245 - 60 .

    BACKGROUND

  • Resick PA, Schnicke MK. Cognitive processing therapy for sexual assault victims. J Consult Clin Psychol. 1992 Oct;60(5):748-56. doi: 10.1037//0022-006x.60.5.748.

    PMID: 1401390BACKGROUND

  • Cahill SP, Rothbaum BO, Resick P, & Follette VM. Cognitive-behavioral therapy for adults. In E. B. Foa, T. M. Keane, M. J. Friedman, & J. A. Cohen (Eds.), Effective treatments for PTSD: Practice Guidelines from the International Society for Traumatic Stress Studies (pp. 139-222). New York: The Guildford Press, 2009.

    BACKGROUND

  • Garrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .

    BACKGROUND

  • Schnurr PP, Friedman MJ, Foy DW, Shea MT, Hsieh FY, Lavori PW, Glynn SM, Wattenberg M, Bernardy NC. Randomized trial of trauma-focused group therapy for posttraumatic stress disorder: results from a department of veterans affairs cooperative study. Arch Gen Psychiatry. 2003 May;60(5):481-9. doi: 10.1001/archpsyc.60.5.481.

    PMID: 12742869BACKGROUND

  • Castillo DT : Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols . Cogn Behav Pract 2004 : 11: 352 - 65 .

    BACKGROUND

  • Castillo DT, C' de Baca J, Qualls C, Bornovalova MA. Group exposure therapy treatment for post-traumatic stress disorder in female veterans. Mil Med. 2012 Dec;177(12):1486-91. doi: 10.7205/milmed-d-12-00186.

    PMID: 23397693BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Diane T Castillo, Ph.D.

    New Mexico VA Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisory Psychologist

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 24, 2014

Study Start

April 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

US(1)