Post Traumatic Stress DisorderNCT02069873
Effectiveness of Cognitive, Exposure, and Skills Group Manualized Treatments in Operations Iraqi (OIF)/Operation Enduring Freedom (OEF) Female Veterans
A study testing 16-Week Group Treatment in people with Post Traumatic Stress Disorder, run by New Mexico VA Healthcare System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- 16-Week Group Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
About this study
Official title: Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD
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.
Read the detailed description
OBJECTIVES: The objectives are to 1) evaluate the effectiveness of exposure, cognitive, and skills (assertiveness/relaxation) therapies within a 16-session group; and 2) evaluate the relative contribution of each of three treatment components in a manualized treatment group in a sample of OIF/OEF female PTSD veterans. HYPOTHESES: Hypothesis 1. Female OIF/OEF PTSD veterans will show reductions in PTSD symptoms and improvement in general functioning after participation in a structured group treatment compared to a wait-list control group. Hypothesis 2. Exposure and cognitive components will show greater improvement in PTSD symptoms than the skills component. RESEARCH DESIGN/BACKGROUND: Based on studies with male combat veterans, female civilian rape victims, and female veterans, therapies most effective for Posttraumatic Stress Disorder (PTSD) are exposure therapy (1,2,3) and cognitive restructuring (4), with less improvement found in other treatments, such as relaxation and assertiveness training (5). Most examinations of PTSD treatments have been conducted in an individual format, but most PTSD treatments offered in Veterans Administration (VA) hospital PTSD programs are conducted in a group format (6). It is critical to determine if these therapies work in a group setting, as only one study (7) found no differences in exposure therapy compared to a support group. In a comprehensive manualized group treatment protocol (8) exposure therapy provided in a group was found effective (9). The aim of the present study is to establish the effectiveness of exposure therapy, among other evidence-based therapies, in a well designed randomized study. METHODOLOGY: Castillo's (8) manualized group treatment protocol for female veterans with PTSD will be modified into a 16-week treatment group with a five-week exposure, five-week cognitive, and four-week skills treatment blocks. Seventy-two subjects will be assessed with structured interviews (SCID and CAPS) and questionnaires (Traumatic Life Events and Quality of Life Inventory) and randomized into one of two arms: 16-week immediate treatment, or a 16-week wait-list control, the latter of which will be reassessed and offered the study treatment. Oversampling will result in 72 subjects in the active treatment arm. Subjects will be reassessed upon completion of treatment or wait-list, at 3, and 6 months following treatment. All treatment groups will include three female OIF/OEF veterans positive for PTSD. The treatment blocks will be varied into six possible orders to control for order effects and the PTSD Symptom Checklist will be administered after each treatment block. Data will be collected for three years. CLINICAL RELATIONSHIPS: Significant results will contribute to the establishment of evidence-based treatments in a manualized treatment group for all veterans with a PTSD diagnosis. FINDINGS: Present findings from Dr. Castillo's lab suggest the effectiveness of exposure therapy in a group setting.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- 16-Week Group Treatment
- Keywords
- Post Traumatic Stress Disorder, Group, Treatment, Cognitive, Exposure, Skills, Women, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-Week Group TreatmentBehavioural
Also called Cognitive treatment, Exposure treatment, Skills treatment, Group treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Self-report questionnaire measures 8 life-functioning scales summarized by two content scales--Mental and Physical functioning.
Measured: 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.
QOLI is a self-report questionnaire measuring overall quality of life across 16 domains.
Measured: 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).
The PCL is a self-report questionnaire measuring 17 PTSD symptoms.
Measured: Baseline, after each treatment block (every 5 weeks), post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startApr 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico VA Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Diane T. Castillo, Ph.D., New Mexico VA Healthcare System
- Investigators
- Diane T Castillo, Ph.D., Principal investigator, New Mexico VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069873
- Sponsor's protocol ID
- W81XWH-08-2-0022
- Other IDs
- PT074309
- Status last verified
- Feb 2014
- First submitted
- 14 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 1955605Schnurr 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.
PubMed 17327524Keane TM , Fairbank JA , Caddell JM , Zimering RT : Implosive (flooding) therapy reduces symptoms of PTSD in Vietnam combat Veterans . Behav Ther 1989 ; 20: 245 - 60 .
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.
PubMed 1401390Cahill 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.
Garrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .
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.
PubMed 12742869Castillo DT : Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols . Cogn Behav Pract 2004 : 11: 352 - 65 .
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.
PubMed 23397693
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD
- ClinicalTrials.gov ID
- NCT02069873
- Acronym / sponsor ID
- W81XWH-08-2-0022
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder, Group, Treatment, Cognitive, Exposure, Skills, Women, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- New Mexico VA Healthcare SystemUS federal agency
- Study start
- Apr 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES: The objectives are to 1) evaluate the effectiveness of exposure, cognitive, and skills (assertiveness/relaxation) therapies within a 16-session group; and 2) evaluate the relative contribution of each of three treatment components in a manualized treatment group in a sample of OIF/OEF female PTSD veterans. HYPOTHESES: Hypothesis 1. Female OIF/OEF PTSD veterans will show reductions in PTSD symptoms and improvement in general functioning after participation in a structured group treatment compared to a wait-list control group. Hypothesis 2. Exposure and cognitive components will show greater improvement in PTSD symptoms than the skills component. RESEARCH DESIGN/BACKGROUND: Based on studies with male combat veterans, female civilian rape victims, and female veterans, therapies most effective for Posttraumatic Stress Disorder (PTSD) are exposure therapy (1,2,3) and cognitive restructuring (4), with less improvement found in other treatments, such as relaxation and assertiveness training (5). Most examinations of PTSD treatments have been conducted in an individual format, but most PTSD treatments offered in Veterans Administration (VA) hospital PTSD programs are conducted in a group format (6). It is critical to determine if these therapies work in a group setting, as only one study (7) found no differences in exposure therapy compared to a support group. In a comprehensive manualized group treatment protocol (8) exposure therapy provided in a group was found effective (9). The aim of the present study is to establish the effectiveness of exposure therapy, among other evidence-based therapies, in a well designed randomized study. METHODOLOGY: Castillo's (8) manualized group treatment protocol for female veterans with PTSD will be modified into a 16-week treatment group with a five-week exposure, five-week cognitive, and four-week skills treatment blocks. Seventy-two subjects will be assessed with structured interviews (SCID and CAPS) and questionnaires (Traumatic Life Events and Quality of Life Inventory) and randomized into one of two arms: 16-week immediate treatment, or a 16-week wait-list control, the latter of which will be reassessed and offered the study treatment. Oversampling will result in 72 subjects in the active treatment arm. Subjects will be reassessed upon completion of treatment or wait-list, at 3, and 6 months following treatment. All treatment groups will include three female OIF/OEF veterans positive for PTSD. The treatment blocks will be varied into six possible orders to control for order effects and the PTSD Symptom Checklist will be administered after each treatment block. Data will be collected for three years. CLINICAL RELATIONSHIPS: Significant results will contribute to the establishment of evidence-based treatments in a manualized treatment group for all veterans with a PTSD diagnosis. FINDINGS: Present findings from Dr. Castillo's lab suggest the effectiveness of exposure therapy in a group setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 16-Week Group Treatment | Experimental | Behavioral: 16-Week Group TreatmentThe 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. |
| 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16-Week Group TreatmentAlso: Cognitive treatment, Exposure treatment, Skills treatment, Group treatmentWithin 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. | Behavioural | 16-Week Group Treatment |
Primary outcome
Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.
Time frame: Baseline, post-treatment, 3 months follow up, 6 months follow up.
Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD).
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, after each treatment block (every 5 weeks), post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Background: PubMed 1955605Foa 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.
- Background: PubMed 17327524Schnurr 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.
- BackgroundKeane 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: PubMed 1401390Resick 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.
- BackgroundCahill 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.
- BackgroundGarrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .
- Background: PubMed 12742869Schnurr 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.
- BackgroundCastillo DT : Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols . Cogn Behav Pract 2004 : 11: 352 - 65 .
- Background: PubMed 23397693Castillo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane T Castillo, Ph.D. principal investigator
New Mexico VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16-Week Group Treatment in people with Post Traumatic Stress Disorder, run by New Mexico VA Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later. (time frame: Baseline, post-treatment, 3 months follow up, 6 months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02069873, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.