DepressionNCT02039973
Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
A study testing Task-sharing approach to group therapy in people with Depression, run by Harvard Medical School (HMS and HSDM) at 1 site in Tanzania.
Trial summary
Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Task-sharing approach to group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Jul 2013to 31 Dec 2017
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women who access PMTCT-plus services at MCH clinics in Dar es Salaam
- HIV-positive serostatus
- screen positive for depression
- less than 28 weeks of gestation
- confirm they will attend postnatal services at the maternal and child health service they enrolled in for antenatal care for at least two years after they give birth
Who cannot join
- any woman less than 18 years of age
- HIV-negative
- screened negative for depression
- screened positive for depression and assessed to be of high suicide risk requiring immediate emergency referral for care
- not able to continue to receive care at the MCH clinic where they were initially enrolled for at least two years after giving birth
Trial locations and contacts
1 site in 1 country.
About this study
Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. The long-term intent of the research is to bridge this gap with the overall goal to examine the potential for successful integration of enhanced mental health care and brief group interventions among HIV-positive women receiving PMTCT-plus services and to evaluate a combination of evidence-based approaches for treatment of depression in this vulnerable population in Tanzania.
Read the detailed description
In resource-limited settings, there has been a significant increase in access to antiretroviral therapy (ART) in recent years. Although there remain serious limitations in access to ART in these settings, for many who have initiated and continue treatment, HIV disease is a chronic condition that needs to be managed over time. There is considerable evidence that individuals with chronic illness have an increased risk of depression, in part related to the challenges in coping and managing their illness. Rates for depression during pregnancy in women living with HIV are estimated to be higher.
Despite this relatively high burden of depression among persons living with HIV/AIDS (PLHA), it has been documented that clinical staff working with PLHA do not routinely identify or treat depression in this setting. This is in contrast to recent revisions in the Tanzanian health policy that emphasize integrating mental health and HIV care at district and lower level health care services. The long-term intent of the research is to bridge this gap between Tanzanian health policy and implementation of integrating mental health care among pre- and post-natal women receiving HIV care. Therefore, the overall goal of the proposed study is to examine the potential for successful integration of enhanced mental health care and group counseling among HIV-positive women receiving preventing mother to child transmission (PMTCT)-plus services and to evaluate a combination of evidence-based approaches in treatment of depression in this vulnerable population in Tanzania.
Specifically this application aims to:
- Examine the acceptability and feasibility of integrating an enhanced standard of mental health care and group counseling with PMTCT-plus services provided at government-run maternal and child health (MCH) clinics, from the perspectives of: a) facility mental health care focal points and MCH clinic managers, b) perinatal direct care providers; and c) HIV-positive perinatal women;
- Validate a depression screening tool for major depressive disorder (MDD) and suicidality for use in Tanzania; and
- Conduct a cluster randomized controlled trial comparing a task-sharing approach (i.e. problem solving and cognitive behavioral therapy components delivered to groups facilitated by lay community based health care workers (CBHWs) versus improved standard
- Conditions
- Depression
- Being tested
- Task-sharing approach to group therapy, Enhanced standard of care
- Keywords
- HIV, AIDS, Tanzania, depression, perinatal, psychotherapy, task-sharing, problem-solving
- Medical subject headings
- Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-sharing approach to group therapyBehavioural
Participants will also identify, select and clarify common concerns/problems; provide orientation to steps in problem-solving; break down identified problems into manageable pieces; choose pieces of problem to address in facilitated discussion of problem solving for implementing solutions; support the sharing of feedback of strategies used in problem-solving and maintaining pleasurable activities.
Additionally, the intervention to aim to effect behavior by: explaining the links between problems, negative thoughts, choices made on a day-to-day basis, behaviors, and mood (symptoms of depression); facilitate sharing of practical skills to tackle problems, to change mood-related thoughts, choices and/or behaviors; offer and provide feedback on homework assignments to encourage practice of skills; and help participants attribute reported improvements to the use of new skills during feedback sessions.
Enhanced standard of careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Task-sharing approach to group therapy | Experimental | The intervention will consist of problem-solving therapy as well as cognitive behavioral components. Core problem-solving therapy components will involve lay CBHW facilitated discussions to explore symptoms of depression and how problems are related to depression. Core cognitive behavioral components will include lay CBHW facilitated discussions to explain the purpose of the sessions, as well as effect a number of behavioral changes in participants. Receives: Behavioral: Task-sharing approach to group therapy |
| Enhanced standard of care | Active comparator | The control condition will promote an enhanced standard of care. Clinicians and nurses at MCH clinics included in the study will receive a structured one day re-orientation training consistent with the World Health Organization (WHO) mh-GAP guidelines for assessment as well as basic psychosocial and drug treatment of moderate to severe depression in primary care settings. The training will be consistent with the standard of care for mental health among HIV-positive populations as outlined in Tanzanian health policy. In addition, clinical staff will be trained to encourage women to invite their male partners to accompany them at clinic visits, where psycho-education on perinatal depression for couples will be offered for those opting to participate. Receives: Behavioral: Enhanced standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive disorder and suicidality
Using a cut-off score based on the validation study, participants will be classified as having depressive and or suicidality or not. The trial aims to reduce rates of depression and suicidality among participants.
Measured: Q3 2016 after an average of 1.5 years of follow-up
Secondary outcomes (9)
Social support
For this measure, the Duke University-University of North Carolina Functional Social Support Questionnaire will be used; this scale has demonstrated positive correlations with other social support scales. A listing of ten items from this of this questionnaire has been used previously in Tanzania, reflecting dimensions of instrumental and emotional support
Measured: Q3 2016 after an average of 1.5 years of follow-up
Self-Efficacy
The General Self-Efficacy Scale will be used to assess self-efficacy. This scale has demonstrated good internal consistency (Cronbach's alpha ranging from 0.81 to 0.91) and construct validity was shown through positive correlations with optimism and negative correlations with depression and anxiety.
Measured: Q3 2016 after an average of 1.5 years of follow-up
HIV-related stigma
The HIV Stigma Scale developed by Berger et al. will be used to assess stigma; it has been validated in a diverse sample in the U.S. demonstrated construct validity through factor analysis and internal consistency (Cronbach's alpha of 0.96). A sub-sample of these items also demonstrated construct validity of this scale has also been demonstrated in a resource-limited setting.
Measured: Q3 2016 after an average of 1.5 years of follow-up
Intimate partner violence
For intimate partner violence (IPV) the WHO Women's Health and Domestic Violence against Women Questionnaire will be used, which assesses emotional, sexual, and physical violence by intimate partners and has demonstrated good internal consistency ranging from 0.66 to 0.81.
Measured: Q3 2016 after an average of 1.5 years of follow-up
Infant birthwight
The infant's birth weight will be measured at the time of birth.
Measured: At time of birth
Gestational Age and Prematurity
The gestational age of the infant at the time of birth will be measured. Premature infants are those whose gestational age is less than 37 weeks.
Measured: At time of birth
Infant diarrheal disease
The occurrence of diarrheal disease among infants will be assessed during the first two weeks of the infant's life.
Measured: Two weeks after infant's birth
Weight-for-height
Wight and height will be measured as an outcome for the infant, with low weight-for-height being used to classify infants as wasting (more than two standard deviations below the mean).
Measured: Up to 1.5 years after infant birth
Height-for-age
Height and age of infants will be measured at the end of follow-up, and low height-for-age will be used to classify infants as stunted (more than two standard deviations below the mean).
Measured: Up to 1.5 years after infant's birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start1 Jul 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mary Kay Smith Fawzi, Harvard Medical School (HMS and HSDM)
- Investigators
- Mary Kay Smith-Fawzi, ScD, Principal investigator, Harvard Medical School (HMS and HSDM)Sylvia Kaaya, MD, PhD, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039973
- Sponsor's protocol ID
- 1R01MH100338-01
- Other IDs
- 1R01MH100338-01
- Status last verified
- Feb 2018
- First submitted
- 1 Jan 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaaya S, Siril H, Fawzi MCS, Aloyce Z, Araya R, Kaale A, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Larson E. A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial. PLoS Med. 2022 Dec 13;19(12):e1004112. doi: 10.1371/journal.pmed.1004112. eCollection 2022 Dec.
PubMed 36512631Smith Fawzi MC, Siril H, Larson E, Aloyce Z, Araya R, Kaale A, Kamala J, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Kaaya SF. Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania. BMC Public Health. 2020 Jan 20;20(1):80. doi: 10.1186/s12889-019-7907-6.
PubMed 31959151
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
- ClinicalTrials.gov ID
- NCT02039973
- Acronym / sponsor ID
- 1R01MH100338-01
- Conditions
- Depression
- Keywords
- HIV, AIDS, Tanzania, depression, perinatal, psychotherapy, task-sharing, problem-solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Jan 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.
Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. The long-term intent of the research is to bridge this gap with the overall goal to examine the potential for successful integration of enhanced mental health care and brief group interventions among HIV-positive women receiving PMTCT-plus services and to evaluate a combination of evidence-based approaches for treatment of depression in this vulnerable population in Tanzania.
Detailed description
In resource-limited settings, there has been a significant increase in access to antiretroviral therapy (ART) in recent years. Although there remain serious limitations in access to ART in these settings, for many who have initiated and continue treatment, HIV disease is a chronic condition that needs to be managed over time. There is considerable evidence that individuals with chronic illness have an increased risk of depression, in part related to the challenges in coping and managing their illness. Rates for depression during pregnancy in women living with HIV are estimated to be higher.
Despite this relatively high burden of depression among persons living with HIV/AIDS (PLHA), it has been documented that clinical staff working with PLHA do not routinely identify or treat depression in this setting. This is in contrast to recent revisions in the Tanzanian health policy that emphasize integrating mental health and HIV care at district and lower level health care services. The long-term intent of the research is to bridge this gap between Tanzanian health policy and implementation of integrating mental health care among pre- and post-natal women receiving HIV care. Therefore, the overall goal of the proposed study is to examine the potential for successful integration of enhanced mental health care and group counseling among HIV-positive women receiving preventing mother to child transmission (PMTCT)-plus services and to evaluate a combination of evidence-based approaches in treatment of depression in this vulnerable population in Tanzania.
Specifically this application aims to:
- Examine the acceptability and feasibility of integrating an enhanced standard of mental health care and group counseling with PMTCT-plus services provided at government-run maternal and child health (MCH) clinics, from the perspectives of: a) facility mental health care focal points and MCH clinic managers, b) perinatal direct care providers; and c) HIV-positive perinatal women;
- Validate a depression screening tool for major depressive disorder (MDD) and suicidality for use in Tanzania; and
- Conduct a cluster randomized controlled trial comparing a task-sharing approach (i.e. problem solving and cognitive behavioral therapy components delivered to groups facilitated by lay community based health care workers (CBHWs) versus improved standard
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-sharing approach to group therapy | Experimental | Behavioral: Task-sharing approach to group therapyThe intervention will consist of problem-solving therapy as well as cognitive behavioral components. Core problem-solving therapy components will involve lay CBHW facilitated discussions to explore symptoms of depression and how problems are related to depression. Core cognitive behavioral components will include lay CBHW facilitated discussions to explain the purpose of the sessions, as well as effect a number of behavioral changes in participants. |
| Enhanced standard of care | Active comparator | Behavioral: Enhanced standard of careThe control condition will promote an enhanced standard of care. Clinicians and nurses at MCH clinics included in the study will receive a structured one day re-orientation training consistent with the World Health Organization (WHO) mh-GAP guidelines for assessment as well as basic psychosocial and drug treatment of moderate to severe depression in primary care settings. The training will be consistent with the standard of care for mental health among HIV-positive populations as outlined in Tanzanian health policy. In addition, clinical staff will be trained to encourage women to invite their male partners to accompany them at clinic visits, where psycho-education on perinatal depression for couples will be offered for those opting to participate. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant women who access PMTCT-plus services at MCH clinics in Dar es Salaam
- HIV-positive serostatus
- screen positive for depression
- less than 28 weeks of gestation
- confirm they will attend postnatal services at the maternal and child health service they enrolled in for antenatal care for at least two years after they give birth
Key exclusion criteria (5 listed)
- any woman less than 18 years of age
- HIV-negative
- screened negative for depression
- screened positive for depression and assessed to be of high suicide risk requiring immediate emergency referral for care
- not able to continue to receive care at the MCH clinic where they were initially enrolled for at least two years after giving birth
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 |
|---|---|---|
| Task-sharing approach to group therapyParticipants will also identify, select and clarify common concerns/problems; provide orientation to steps in problem-solving; break down identified problems into manageable pieces; choose pieces of problem to address in facilitated discussion of problem solving for implementing solutions; support the sharing of feedback of strategies used in problem-solving and maintaining pleasurable activities. Additionally, the intervention to aim to effect behavior by: explaining the links between problems, negative thoughts, choices made on a day-to-day basis, behaviors, and mood (symptoms of depression); facilitate sharing of practical skills to tackle problems, to change mood-related thoughts, choices and/or behaviors; offer and provide feedback on homework assignments to encourage practice of skills; and help participants attribute reported improvements to the use of new skills during feedback sessions. | Behavioural | Task-sharing approach to group therapy |
| Enhanced standard of care | Behavioural | Enhanced standard of care |
Primary outcome
Depressive disorder and suicidality
Time frame: Q3 2016 after an average of 1.5 years of follow-up
Using a cut-off score based on the validation study, participants will be classified as having depressive and or suicidality or not. The trial aims to reduce rates of depression and suicidality among participants.
9 secondary outcomes
Social support
Time frame: Q3 2016 after an average of 1.5 years of follow-up
Self-Efficacy
Time frame: Q3 2016 after an average of 1.5 years of follow-up
HIV-related stigma
Time frame: Q3 2016 after an average of 1.5 years of follow-up
Intimate partner violence
Time frame: Q3 2016 after an average of 1.5 years of follow-up
Infant birthwight
Time frame: At time of birth
Gestational Age and Prematurity
Time frame: At time of birth
Infant diarrheal disease
Time frame: Two weeks after infant's birth
Weight-for-height
Time frame: Up to 1.5 years after infant birth
Height-for-age
Time frame: Up to 1.5 years after infant's birth
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 22 Feb 2018.
- Derived from this study: PubMed 36512631Kaaya S, Siril H, Fawzi MCS, Aloyce Z, Araya R, Kaale A, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Larson E. A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial. PLoS Med. 2022 Dec 13;19(12):e1004112. doi: 10.1371/journal.pmed.1004112. eCollection 2022 Dec.
- Derived from this study: PubMed 31959151Smith Fawzi MC, Siril H, Larson E, Aloyce Z, Araya R, Kaale A, Kamala J, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Kaaya SF. Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania. BMC Public Health. 2020 Jan 20;20(1):80. doi: 10.1186/s12889-019-7907-6.
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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.
Mary Kay Smith-Fawzi, ScD principal investigator
Harvard Medical School (HMS and HSDM)
Sylvia Kaaya, MD, PhD principal investigator
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-sharing approach to group therapy in people with Depression, run by Harvard Medical School (HMS and HSDM) at 1 site in Tanzania.
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 5 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 22 Feb 2018. 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 Tanzania. 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?
Depressive disorder and suicidality (time frame: Q3 2016 after an average of 1.5 years of follow-up). 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 NCT02039973, which also lists 2 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 22 Feb 2018.