Posttraumatic Stress DisorderNCT00984698
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
A study testing Cognitive Behavioral Social Rhythm Group Therapy and Present Centered Group Therapy in people with Posttraumatic Stress Disorder and Depression, run by University of Arizona at 2 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Insomnia Disorder
- What is being tested?
- Cognitive Behavioral Social Rhythm Group Therapy and Present Centered Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran or active duty military personnel
- Current posttraumatic stress disorder (PTSD), at least moderate severity
- Criterion A exposure to trauma occurring after the age of 18
- Major depressive disorder (MDD), at least moderate severity
- Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine
Who cannot join
- Current or past bipolar disorder
- Current psychotic disorder
- Substance abuse/dependence in last 30 days
- Uncontrolled serious medical condition or neurological disorder
- Currently working an overnight shift
- Primary untreated sleep apnea, restless legs syndrome
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Arizona VA Healthcare System (SAVAHCS)
Tucson, Arizona, 85723
University of Arizona
Tucson, Arizona, 85724
About this study
The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.
Read the detailed description
The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.
- Conditions
- Posttraumatic Stress Disorder, Depression, Insomnia Disorder
- Being tested
- Cognitive Behavioral Social Rhythm Group Therapy, Present Centered Group Therapy
- Keywords
- Posttraumatic Stress Disorder, Depression, Sleep Initiation and Maintenance Disorders, Insomnia, Psychotherapy, Group, Cognitive Behavioral Therapy, Randomized Controlled Trial, Veterans, Social Rhythms
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Social Rhythm Group TherapyBehavioural
12 weeks, 2h structured group therapy
Present Centered Group TherapyBehavioural
12 weeks, 2h relatively unstructured group therapy
| Study group | Role | What they receive |
|---|---|---|
| Structured Therapy | Experimental | Cognitive Behavioral Social Rhythm Group Therapy is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events. Receives: Behavioral: Cognitive Behavioral Social Rhythm Group Therapy |
| Unstructured Therapy | Active comparator | Present Centered Group Therapy includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events. Receives: Behavioral: Present Centered Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).
Measured: post-treatment, at 12 weeks
Secondary outcomes (1)
PTSD
Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).
Measured: post-treatment, at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Southern Arizona VA Health Care System
- Responsible party
- Principal investigator, Tricia Haynes, University of Arizona
- Investigators
- Patricia Haynes, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984698
- Sponsor's protocol ID
- W81XWH-08-2-0121
- Status last verified
- Feb 2014
- First submitted
- 24 Sep 2009
- Last updated
- 31 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Haynes PL, Burger SB, Kelly M, Emert S, Perkins S, Shea MT. Cognitive behavioral social rhythm group therapy versus present centered group therapy for veterans with posttraumatic stress disorder and major depressive disorder: A randomized controlled pilot trial. J Affect Disord. 2020 Dec 1;277:800-809. doi: 10.1016/j.jad.2020.09.009. Epub 2020 Sep 7.
PubMed 33065820
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00984698
- Acronym / sponsor ID
- W81XWH-08-2-0121
- Conditions
- Posttraumatic Stress Disorder, Depression, Insomnia Disorder
- Keywords
- Posttraumatic Stress Disorder, Depression, Sleep Initiation and Maintenance Disorders, Insomnia, Psychotherapy, Group, Cognitive Behavioral Therapy, Randomized Controlled Trial, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Southern Arizona VA Health Care System
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Posted 31 Mar 2014
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 this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.
Detailed description
The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Therapy | Experimental | Behavioral: Cognitive Behavioral Social Rhythm Group TherapyCognitive Behavioral Social Rhythm Group Therapy is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events. |
| Unstructured Therapy | Active comparator | Behavioral: Present Centered Group TherapyPresent Centered Group Therapy includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran or active duty military personnel
- Current posttraumatic stress disorder (PTSD), at least moderate severity
- Criterion A exposure to trauma occurring after the age of 18
- Major depressive disorder (MDD), at least moderate severity
- Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine
Key exclusion criteria (6 listed)
- Current or past bipolar disorder
- Current psychotic disorder
- Substance abuse/dependence in last 30 days
- Uncontrolled serious medical condition or neurological disorder
- Currently working an overnight shift
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 |
|---|---|---|
| Cognitive Behavioral Social Rhythm Group Therapy12 weeks, 2h structured group therapy | Behavioural | Structured Therapy |
| Present Centered Group Therapy12 weeks, 2h relatively unstructured group therapy | Behavioural | Unstructured Therapy |
Primary outcome
Depression
Time frame: post-treatment, at 12 weeks
Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).
1 secondary outcome
PTSD
Time frame: post-treatment, at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33065820Haynes PL, Burger SB, Kelly M, Emert S, Perkins S, Shea MT. Cognitive behavioral social rhythm group therapy versus present centered group therapy for veterans with posttraumatic stress disorder and major depressive disorder: A randomized controlled pilot trial. J Affect Disord. 2020 Dec 1;277:800-809. doi: 10.1016/j.jad.2020.09.009. Epub 2020 Sep 7.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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.
Patricia Haynes, PhD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Social Rhythm Group Therapy and Present Centered Group Therapy in people with Posttraumatic Stress Disorder and Depression, run by University of Arizona at 2 sites 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 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression (time frame: post-treatment, at 12 weeks). 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 NCT00984698, 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 31 Mar 2014.