DepressionPhase 2NCT00843700
Women's Depression Treatment Study
A Phase 2 study testing Interpersonal Psychotherapy-Trauma in Community Settings and Treatment as Usual in people with Depression, run by University of Rochester at 1 site in United States.
Trial summary
The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal Psychotherapy-Trauma in Community Settings and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2012
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Current Major Depression
- History of sexual abuse prior to age 18
Who cannot join
- Bipolar disorder
- Psychosis or schizophrenia
- Active alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center
The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.
Read the detailed description
Evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. The aim of this randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.
- Conditions
- Depression
- Being tested
- Interpersonal Psychotherapy-Trauma in Community Settings, Treatment as Usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy-Trauma in Community SettingsBehavioural
Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.
Treatment as UsualBehavioural
Individual psychotherapy following usual care practice in a community mental health center.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Interpersonal Psychotherapy, 16 individual sessions within 32 weeks Receives: Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings |
| Individual Psychotherapy | Active comparator | Individual Psychotherapy, 16 individual sessions within 32 weeks Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module
Measured: 20 months
Secondary outcomes (2)
Beck Depression Inventory
Measured: 20 months
Hamilton Rating Scale for Depression
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startSep 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Talbot, University of Rochester
- Investigators
- Nancy L Talbot, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843700
- Sponsor's protocol ID
- RSRB00020535
- Other IDs
- 1R01MH076928
- Status last verified
- Jan 2014
- First submitted
- 12 Feb 2009
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Talbot NL, Gamble SA. IPT for women with trauma histories in community mental health care. Journal of Contemporary Psychotherapy 38(1): 35-44, 2008.
Lestrade KN, Talbot NL, Ward EA, Cort NA. High-risk sexual behaviors among depressed Black women with histories of intrafamilial and extrafamilial childhood sexual abuse. Child Abuse Negl. 2013 Jun;37(6):400-3. doi: 10.1016/j.chiabu.2013.01.007. Epub 2013 Mar 14.
PubMed 23499057Glanton Holzhauer C, Duberstein P, Ward E, Talbot N. Reducing posttraumatic stress disorder symptom severity among depressed women with childhood sexual abuse histories in interpersonal psychotherapy-trauma: The role of improved social functioning. Psychol Trauma. 2024 Apr;16(Suppl 1):S285-S292. doi: 10.1037/tra0001293. Epub 2022 Jun 2.
PubMed 35653744Cankaya B, Talbot NL, Ward EA, Duberstein PR. Parental sexual abuse and suicidal behaviour among women with major depressive disorder. Can J Psychiatry. 2012 Jan;57(1):45-51. doi: 10.1177/070674371205700108.
PubMed 22296967
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center
- ClinicalTrials.gov ID
- NCT00843700
- Acronym / sponsor ID
- RSRB00020535
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Feb 2009 (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 aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.
Detailed description
Evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. The aim of this randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Behavioral: Interpersonal Psychotherapy-Trauma in Community SettingsInterpersonal Psychotherapy, 16 individual sessions within 32 weeks |
| Individual Psychotherapy | Active comparator | Behavioral: Treatment as UsualIndividual Psychotherapy, 16 individual sessions within 32 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Current Major Depression
- History of sexual abuse prior to age 18
Key exclusion criteria (3 listed)
- Bipolar disorder
- Psychosis or schizophrenia
- Active alcohol or substance abuse
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 |
|---|---|---|
| Interpersonal Psychotherapy-Trauma in Community SettingsInterpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. | Behavioural | Interpersonal Psychotherapy |
| Treatment as UsualIndividual psychotherapy following usual care practice in a community mental health center. | Behavioural | Individual Psychotherapy |
Primary outcome
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module
Time frame: 20 months
2 secondary outcomes
Beck Depression Inventory
Time frame: 20 months
Hamilton Rating Scale for Depression
Time frame: 20 months
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 9 Jan 2014.
- BackgroundTalbot NL, Gamble SA. IPT for women with trauma histories in community mental health care. Journal of Contemporary Psychotherapy 38(1): 35-44, 2008.
- Results publication: PubMed 23499057Lestrade KN, Talbot NL, Ward EA, Cort NA. High-risk sexual behaviors among depressed Black women with histories of intrafamilial and extrafamilial childhood sexual abuse. Child Abuse Negl. 2013 Jun;37(6):400-3. doi: 10.1016/j.chiabu.2013.01.007. Epub 2013 Mar 14.
- Derived from this study: PubMed 35653744Glanton Holzhauer C, Duberstein P, Ward E, Talbot N. Reducing posttraumatic stress disorder symptom severity among depressed women with childhood sexual abuse histories in interpersonal psychotherapy-trauma: The role of improved social functioning. Psychol Trauma. 2024 Apr;16(Suppl 1):S285-S292. doi: 10.1037/tra0001293. Epub 2022 Jun 2.
- Derived from this study: PubMed 22296967Cankaya B, Talbot NL, Ward EA, Duberstein PR. Parental sexual abuse and suicidal behaviour among women with major depressive disorder. Can J Psychiatry. 2012 Jan;57(1):45-51. doi: 10.1177/070674371205700108.
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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 L Talbot, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interpersonal Psychotherapy-Trauma in Community Settings and Treatment as Usual in people with Depression, run by University of Rochester 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 9 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module (time frame: 20 months). 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 NCT00843700, which also lists 4 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 9 Jan 2014.