PTSDNCT00013091
Treatment of Depression in Patients With PTSD
A study testing Self-management therapy; Psychoeducational group therapy in people with PTSD and Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- PTSD, Depression
- What is being tested?
- Self-management therapy; Psychoeducational group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to Sep 2002
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be accepted in the study, patients must (a) meet criteria for combat-related (men's cohort) PTSD and either major depressive disorder of dysthymic disorder, (b) not meet criteria for current or past psychosis, score 24 or greater on a Mini-Mental State Examination cognitive screen, (d) not exhibit active suicidality or severity that would preclude participation in the groups, and (e) agree to random assignment and sign informed consent forms. For the women's groups, patients have PTSD related to sexual trauma.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.
Read the detailed description
Background:
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.
Objectives:
Well-validated treatments of PTSD and its complications are rare. There are no studies of treatment addressing the sequelae of chronic PTSD, including depressive symptomatology. Our study is the first randomized, controlled study of group psychosocial interventions for the combination of PTSD and depression in male and female veterans. The purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders.
Methods:
Male and female veterans with both PTSD and depressive diagnoses will be recruited for the study. Male veterans must have combat-related PTSD, and female veterans will have trauma related to sexual assault. Veterans will be randomly assigned to either Self-Management Therapy (Rehm, 1984), a cognitive-behavioral treatment program for depression, or to a Psychoeducational Group Therapy (Dunn, et al., 1998). Both programs involve short-term group therapies that teach veterans about their disorders, and provide them with new strategies and skills for overcoming them. These therapy groups will be in addition to other standard care that veterans receive within the Trauma Recovery Program at the Houston VA Medical Center. Approximately 120 male veterans and 60 female veterans will be enrolled in the program. Participants will be assessed at pretest, posttest, and at 3-, 6-, and 12-month follow-up periods, utilizing various clinician-administered and self-report instruments of psychiatric symptomatology, psychosocial functioning, constructs targeted by the therapy groups, treatment compliances, and satisfaction.
Status:
Final report preparation.
- Conditions
- PTSD, Depression
- Being tested
- Self-management therapy; Psychoeducational group therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management therapy; Psychoeducational group therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Self-management therapy; Psychoeducational group therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study startOct 1997
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Masking
- Single blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nancy Jo Dunn, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013091
- Sponsor's protocol ID
- IIR 95-074
- Status last verified
- May 2009
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunn NJ, Yanasak E, Schillaci J, Simotas S, Rehm LP, Souchek J, Menke T, Ashton C, Hamilton JD. Personality disorders in veterans with posttraumatic stress disorder and depression. J Trauma Stress. 2004 Feb;17(1):75-82. doi: 10.1023/B:JOTS.0000014680.54051.50.
PubMed 15027797
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depression in Patients With PTSD
- ClinicalTrials.gov ID
- NCT00013091
- Acronym / sponsor ID
- IIR 95-074
- Conditions
- PTSD, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 1997
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 16 Mar 2001 (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.
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.
Detailed description
Background:
Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.
Objectives:
Well-validated treatments of PTSD and its complications are rare. There are no studies of treatment addressing the sequelae of chronic PTSD, including depressive symptomatology. Our study is the first randomized, controlled study of group psychosocial interventions for the combination of PTSD and depression in male and female veterans. The purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders.
Methods:
Male and female veterans with both PTSD and depressive diagnoses will be recruited for the study. Male veterans must have combat-related PTSD, and female veterans will have trauma related to sexual assault. Veterans will be randomly assigned to either Self-Management Therapy (Rehm, 1984), a cognitive-behavioral treatment program for depression, or to a Psychoeducational Group Therapy (Dunn, et al., 1998). Both programs involve short-term group therapies that teach veterans about their disorders, and provide them with new strategies and skills for overcoming them. These therapy groups will be in addition to other standard care that veterans receive within the Trauma Recovery Program at the Houston VA Medical Center. Approximately 120 male veterans and 60 female veterans will be enrolled in the program. Participants will be assessed at pretest, posttest, and at 3-, 6-, and 12-month follow-up periods, utilizing various clinician-administered and self-report instruments of psychiatric symptomatology, psychosocial functioning, constructs targeted by the therapy groups, treatment compliances, and satisfaction.
Status:
Final report preparation.
Study design
- Primary purpose
- Treatment
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Self-management therapy; Psychoeducational group therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be accepted in the study, patients must (a) meet criteria for combat-related (men's cohort) PTSD and either major depressive disorder of dysthymic disorder, (b) not meet criteria for current or past psychosis, score 24 or greater on a Mini-Mental State Examination cognitive screen, (d) not exhibit active suicidality or severity that would preclude participation in the groups, and (e) agree to random assignment and sign informed consent forms. For the women's groups, patients have PTSD related to sexual trauma.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-management therapy; Psychoeducational group therapy | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 15027797Dunn NJ, Yanasak E, Schillaci J, Simotas S, Rehm LP, Souchek J, Menke T, Ashton C, Hamilton JD. Personality disorders in veterans with posttraumatic stress disorder and depression. J Trauma Stress. 2004 Feb;17(1):75-82. doi: 10.1023/B:JOTS.0000014680.54051.50.
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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.
Nancy Jo Dunn, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management therapy; Psychoeducational group therapy in people with PTSD and Depression, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013091, which also lists 1 linked publication.
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 7 Apr 2015.