DepressionNCT02320799
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
A study testing interpersonal psychotherapy and treatment as usual in people with Depression and Posttraumatic Stress Disorder, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Posttraumatic Stress Disorder, HIV
- What is being tested?
- interpersonal psychotherapy 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
- 300 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2015to 31 Jan 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .(1) HIV+ women enrolled at FACES-Kisumu; (2) Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV* on the CIDI; (3) Ability to attend weekly therapy sessions and repeated measures; (4) Age greater than 18 years; (5) Ability to give informed consent.
Who cannot join
- (1) Cognitive dysfunction requiring a higher level of care or compromising ability to participate in IPT**; (2) severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT; (3) current drug and alcohol dependence requiring substance use treatment. Although PTSD is associated with substance abuse in EuroAmerican populations, a recent study of 5175 FACES patients found that over 80% of this LMIC population use no alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya
The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes.
Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone.
Hypothesis 2: IPT+TAU will be acceptable and feasible.
Read the detailed description
We will use a parallel design with FACES Treatment as Usual (TAU) control to provide IPT once per week for twelve weeks to HIV+GBV+ women meeting CIDI diagnostic criteria for depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV. Blocked randomization will be used to evenly distribute 120 participants to (1) IPT + TAU or (2) TAU for 12 weeks. The TAU group will be offered IPT treatment following the initial 12 week trial. Thus, all study subjects will receive TAU throughout the study and they will all receive IPT in either the first or second half of the study. My research team at FACES will be recruited for IPT training as potential therapists in the IPT pilot. A run-in study design will be used, assigning one training case apiece to each of the 8 therapists to practice IPT skills. Both IPT + TAU and TAU groups will be measured at baseline and weeks 12, 24 and 36 by blinded assessment. At FACES, TAU resources for HIV+GBV+ women include medical professionals, counseling, community elders, church leaders, police, and a pro-bono legal aid, all of who have all been involved with past FACES GBV interventions.
- Conditions
- Depression, Posttraumatic Stress Disorder, HIV
- Being tested
- interpersonal psychotherapy, treatment as usual
- Keywords
- interpersonal psychotherapy, HIV, women, gender based violence, mental health, africa, kenya, global mental health, HIV treatment adherence
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpersonal psychotherapyBehavioural
Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety
treatment as usualBehavioural
Clinic psychosocial treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual | Active comparator | Usual Clinic psychosocial treatment Receives: Behavioral: treatment as usual |
| interpersonal psychotherapy | Experimental | Interpersonal Psychotherapy is an evidence-based structured, brief psychotherapy which focuses on improving relationships in order to improve mood and reduce anxiety. Receives: Behavioral: interpersonal psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, PTSD
structured clinical interview: Composite International Diagnostic Interview (CIDI)
Measured: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
Secondary outcomes (2)
ARV adherence
Visual Analog Scale self-report
Measured: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
HIV viral load
blood draw
Measured: 12 weeks, 24 weeks, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startSep 2015
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 California, San FranciscoThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Susan M Meffert, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320799
- Sponsor's protocol ID
- 1K23MH098767-01A1
- Other IDs
- K23MH098767
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2014
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Meffert SM, Neylan TC, McCulloch CE, Blum K, Cohen CR, Bukusi EA, Verdeli H, Markowitz JC, Kahn JG, Bukusi D, Thirumurthy H, Rota G, Rota R, Oketch G, Opiyo E, Ongeri L. Interpersonal psychotherapy delivered by nonspecialists for depression and posttraumatic stress disorder among Kenyan HIV-positive women affected by gender-based violence: Randomized controlled trial. PLoS Med. 2021 Jan 11;18(1):e1003468. doi: 10.1371/journal.pmed.1003468. eCollection 2021 Jan.
PubMed 33428625Opiyo E, Ongeri L, Rota G, Verdeli H, Neylan T, Meffert S. Collaborative Interpersonal Psychotherapy for HIV-Positive Women in Kenya: A Case Study From the Mental Health, HIV and Domestic Violence (MIND) Study. J Clin Psychol. 2016 Aug;72(8):779-83. doi: 10.1002/jclp.22359. Epub 2016 Jul 27.
PubMed 27463639Onu C, Ongeri L, Bukusi E, Cohen CR, Neylan TC, Oyaro P, Rota G, Otewa F, Delucchi KL, Meffert SM. Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial. Trials. 2016 Feb 3;17:64. doi: 10.1186/s13063-016-1187-6.
PubMed 26841875
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya
- ClinicalTrials.gov ID
- NCT02320799
- Acronym / sponsor ID
- 1K23MH098767-01A1
- Conditions
- Depression, Posttraumatic Stress Disorder, HIV
- Keywords
- interpersonal psychotherapy, HIV, women, gender based violence, mental health, africa, kenya, global mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2015 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 Dec 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 aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes.
Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone.
Hypothesis 2: IPT+TAU will be acceptable and feasible.
Detailed description
We will use a parallel design with FACES Treatment as Usual (TAU) control to provide IPT once per week for twelve weeks to HIV+GBV+ women meeting CIDI diagnostic criteria for depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV. Blocked randomization will be used to evenly distribute 120 participants to (1) IPT + TAU or (2) TAU for 12 weeks. The TAU group will be offered IPT treatment following the initial 12 week trial. Thus, all study subjects will receive TAU throughout the study and they will all receive IPT in either the first or second half of the study. My research team at FACES will be recruited for IPT training as potential therapists in the IPT pilot. A run-in study design will be used, assigning one training case apiece to each of the 8 therapists to practice IPT skills. Both IPT + TAU and TAU groups will be measured at baseline and weeks 12, 24 and 36 by blinded assessment. At FACES, TAU resources for HIV+GBV+ women include medical professionals, counseling, community elders, church leaders, police, and a pro-bono legal aid, all of who have all been involved with past FACES GBV interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment as usual | Active comparator | Behavioral: treatment as usualUsual Clinic psychosocial treatment |
| interpersonal psychotherapy | Experimental | Behavioral: interpersonal psychotherapyInterpersonal Psychotherapy is an evidence-based structured, brief psychotherapy which focuses on improving relationships in order to improve mood and reduce anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- .(1) HIV+ women enrolled at FACES-Kisumu; (2) Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV* on the CIDI; (3) Ability to attend weekly therapy sessions and repeated measures; (4) Age greater than 18 years; (5) Ability to give informed consent.
Key exclusion criteria (1 listed)
- (1) Cognitive dysfunction requiring a higher level of care or compromising ability to participate in IPT**; (2) severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT; (3) current drug and alcohol dependence requiring substance use treatment. Although PTSD is associated with substance abuse in EuroAmerican populations, a recent study of 5175 FACES patients found that over 80% of this LMIC population use no alcohol.
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 psychotherapyInterpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety | Behavioural | interpersonal psychotherapy |
| treatment as usualClinic psychosocial treatment as usual | Behavioural | treatment as usual |
Primary outcome
Depression, PTSD
Time frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
structured clinical interview: Composite International Diagnostic Interview (CIDI)
2 secondary outcomes
ARV adherence
Time frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
HIV viral load
Time frame: 12 weeks, 24 weeks, 36 weeks
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 1 May 2019.
- Derived from this study: PubMed 33428625Meffert SM, Neylan TC, McCulloch CE, Blum K, Cohen CR, Bukusi EA, Verdeli H, Markowitz JC, Kahn JG, Bukusi D, Thirumurthy H, Rota G, Rota R, Oketch G, Opiyo E, Ongeri L. Interpersonal psychotherapy delivered by nonspecialists for depression and posttraumatic stress disorder among Kenyan HIV-positive women affected by gender-based violence: Randomized controlled trial. PLoS Med. 2021 Jan 11;18(1):e1003468. doi: 10.1371/journal.pmed.1003468. eCollection 2021 Jan.
- Derived from this study: PubMed 27463639Opiyo E, Ongeri L, Rota G, Verdeli H, Neylan T, Meffert S. Collaborative Interpersonal Psychotherapy for HIV-Positive Women in Kenya: A Case Study From the Mental Health, HIV and Domestic Violence (MIND) Study. J Clin Psychol. 2016 Aug;72(8):779-83. doi: 10.1002/jclp.22359. Epub 2016 Jul 27.
- Derived from this study: PubMed 26841875Onu C, Ongeri L, Bukusi E, Cohen CR, Neylan TC, Oyaro P, Rota G, Otewa F, Delucchi KL, Meffert SM. Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial. Trials. 2016 Feb 3;17:64. doi: 10.1186/s13063-016-1187-6.
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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.
Susan M Meffert, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interpersonal psychotherapy and treatment as usual in people with Depression and Posttraumatic Stress Disorder, run by University of California, San Francisco at 1 site in Kenya.
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 1 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 1 May 2019. 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 Kenya. 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?
Depression, PTSD (time frame: Change from 0-12 weeks, 12-24 weeks and 24-36 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 NCT02320799, which also lists 3 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 1 May 2019.