Post-Traumatic Stress DisorderNCT00348036
Group Intervention for Interpersonal Trauma
A study testing Group Intervention for Interpersonal Trauma and Information only in people with Post-Traumatic Stress Disorder and Depression, run by Georgetown University at 1 site in United States.
Trial summary
This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder, Depression
- What is being tested?
- Group Intervention for Interpersonal Trauma and Information only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2010
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exposure to an interpersonal traumatic event
- Diagnosis of depression or PTSD (threshold or subthreshold)
- Functional literacy
Who cannot join
- Apparent incoherence or disorientation
- Apparent intoxication at recruitment
- Hearing impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Trauma Interventions for Low-income Women in Primary Care
This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.
Read the detailed description
The aim of this study is to assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder (PTSD) following interpersonal trauma exposure. Group participants will be recruited from public sector/safety net primary care clinics. Study participants will be randomized to immediate or delayed treatment. Participants in both conditions will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier. Participants will be free to attend any of the sessions they missed during the first group when the group repeats. Participants in the delayed condition will be able to attend the groups after a 12-week waiting period. Assessments of PTSD, depression, functioning, and quality of life will be conducted at three time points: baseline (prior to the start of the group), 12 weeks after the start of the group, and 6 months from the start of the group. Gift cards will be sent to the women for completing each of the assessments.
- Conditions
- Post-Traumatic Stress Disorder, Depression
- Being tested
- Group Intervention for Interpersonal Trauma, Information only
- Keywords
- Major Depression, Trauma, Primary Care, Low-Income Patients
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Depressive Disorder, Major, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Intervention for Interpersonal TraumaBehavioural
Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier.
Information onlyOther
Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.
| Study group | Role | What they receive |
|---|---|---|
| Group therapy | Experimental | Participants will receive interpersonal group therapy. Receives: Behavioral: Group Intervention for Interpersonal Trauma |
| Control | Active comparator | Participants will receive information only on PTSD. Receives: Other: Information only |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD checklist
Measured: Measured at baseline, Week 12, and Month 6
Hamilton Depression Inventory
Measured: Measured at baseline, Week 12, and Month 6
Secondary outcomes (2)
Inventory of Interpersonal Problems
Measured: Measured at baseline, Week 12, and Month 6
Health care utilization
Measured: Measured at baseline, Week 12, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bonnie L. Green, PhD, Principal investigator, Georgetown University Medical School Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348036
- Sponsor's protocol ID
- P20MH068450
- Other IDs
- P20MH068450, DSIR 83-ATAS
- Status last verified
- Apr 2013
- First submitted
- 30 Jun 2006
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Interventions for Low-income Women in Primary Care
- ClinicalTrials.gov ID
- NCT00348036
- Acronym / sponsor ID
- P20MH068450
- Conditions
- Post-Traumatic Stress Disorder, Depression
- Keywords
- Major Depression, Trauma, Primary Care, Low-Income Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Jul 2006 (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.
This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.
Detailed description
The aim of this study is to assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder (PTSD) following interpersonal trauma exposure. Group participants will be recruited from public sector/safety net primary care clinics. Study participants will be randomized to immediate or delayed treatment. Participants in both conditions will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier. Participants will be free to attend any of the sessions they missed during the first group when the group repeats. Participants in the delayed condition will be able to attend the groups after a 12-week waiting period. Assessments of PTSD, depression, functioning, and quality of life will be conducted at three time points: baseline (prior to the start of the group), 12 weeks after the start of the group, and 6 months from the start of the group. Gift cards will be sent to the women for completing each of the assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group therapy | Experimental | Behavioral: Group Intervention for Interpersonal TraumaParticipants will receive interpersonal group therapy. |
| Control | Active comparator | Other: Information onlyParticipants will receive information only on PTSD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Exposure to an interpersonal traumatic event
- Diagnosis of depression or PTSD (threshold or subthreshold)
- Functional literacy
Key exclusion criteria (3 listed)
- Apparent incoherence or disorientation
- Apparent intoxication at recruitment
- Hearing impairment
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 |
|---|---|---|
| Group Intervention for Interpersonal TraumaParticipants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier. | Behavioural | Group therapy |
| Information onlyParticipants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. | Other | Control |
Primary outcome
PTSD checklist
Time frame: Measured at baseline, Week 12, and Month 6
Hamilton Depression Inventory
Time frame: Measured at baseline, Week 12, and Month 6
2 secondary outcomes
Inventory of Interpersonal Problems
Time frame: Measured at baseline, Week 12, and Month 6
Health care utilization
Time frame: Measured at baseline, Week 12, and Month 6
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 30 Apr 2013.
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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.
Bonnie L. Green, PhD principal investigator
Georgetown University Medical School Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Intervention for Interpersonal Trauma and Information only in people with Post-Traumatic Stress Disorder and Depression, run by Georgetown University 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 3 inclusion and 3 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 30 Apr 2013. 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?
PTSD checklist (time frame: Measured at baseline, Week 12, and Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2013.