DepressionNCT04110405
Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC
A study testing Stepped Care in people with Depression and Anxiety, run by University of Illinois Chicago at 20 sites in Tajikistan.
Trial summary
This study examines: 1) short-term and longitudinal impacts of stepped care on women with depression and the possible roles of mediators and moderators; 2) clinic- (readiness to adopt an innovation, leadership support and climate) and provider-level (preparedness, motivation and fidelity) factors that may affect… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Stepped Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 20 sitesTajikistan
- Study dates
- 14 Aug 2020to 1 Oct 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female Tajik citizen between 18 and 45 years old
- score >16 on the HAM-D
- no current or past substance use
- willing to participate in the intervention and research procedures
- able to give written informed consent.
Who cannot join
- women who are older or younger than 18 - 45 years
- women who do not score >16 on the HAM-D
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Tajikistan20 sites
City Health Center #4
Dushanbe
City Health Center #5
Dushanbe
Dushanbe City Health Center #12
Dushanbe
Dushanbe City Health Center #13
Dushanbe
Dushanbe City Health Center #15
Dushanbe
Dushanbe City Health Center #1
Dushanbe
Dushanbe City Health Center #2
Dushanbe
Dushanbe City Health Center #6
Dushanbe
Guliston District Health Center
Guliston
Gafurov District Health Center
Khujand
Kayrokum District Health Center #7
Khujand
Khujand City Health Center #1
Khujand
Khujand City Health Center #2
Khujand
Khujand City Health Center #3
Khujand
Khujand City Health Center #4
Khujand
Khujand City Health Center #5
Khujand
Khujand City Health Center #6
Khujand
Rudaki District Health Center
Rŭdakí
Shahrinav District Health Center
Shahrinav
Varzob District Health Center
Varzob
About this study
This study examines: 1) short-term and longitudinal impacts of stepped care on women with depression and the possible roles of mediators and moderators; 2) clinic- (readiness to adopt an innovation, leadership support and climate) and provider-level (preparedness, motivation and fidelity) factors that may affect stepped care implementation; and 3) the differential impact of two implementation approaches (a clinic implementation teams versus implementation training by the research team). It utilizes Curran's hybrid effectiveness implementation design, mixed methods, and a longitudinal design with assessments at pre, 3 months, 6 months, and 12 months. A total of 18 primary care clinics, set in both rural and urban communities in Tajikistan, will be involved, with 12 delivering the intervention and 6 acting as controls. 8 providers (3 nurses, 3 peers, and 2 doctors) will be recruited at each of the 12 intervention clinics for a total of 96 providers; 35 women with depression will be recruited from each clinic for a total of 630 women.
Read the detailed description
This research will advance mental healthcare task sharing in effectiveness and implementation testing of a stepped care model for LMICs. It uses nurses and mental health peers to treat depression and potential co-occurring anxiety among women in primary care. The study addresses Grand Challenges in Global Mental Health Goal C to foster integration of mental health into primary care and NIMH Strategic Aim 3 by developing new and better interventions that incorporate the diverse needs and circumstances of people with mental illness. It utilizes Curran's hybrid effectiveness implementation design. To improve implementation, it examines the impact of clinic implementation teams in readying the clinic and service providers. Additionally, it explores how RDoC neuroscience contributes to implementation science through enhancing the evaluation and targeting of stepped care. This study will enable new collaborative research activities, in tandem with network building, mentorship and training, and dissemination of findings, which will further build the LMIC capacity for implementation science research and development of evidence-based medicine by strengthening Tajikistan's individual and institutional research capabilities.
Globally, young women bear a disproportionate burden of common mental disorders, and especially including depression and potentially co-occurring anxiety. With current care models, this burden cannot be lifted without finding ways to deliver mental health prevention and treatment services and illness self-management to women in primary care. Our previous research in Tajikistan has demonstrated that women are exposed to serious risks for mental illness, and how peers and primary care nurses have played major but largely informal roles in helping women with mental health problems. Therefore, the investigators developed and tested for feasibility a stepped care model which showed very strong treatment effects. This stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline.
This project will scale-up the intervention in multiple polyclinics, so as to examine its effectiveness (Aim 2) and to compare two implementation strategies (Aim 3). This presents a remarkable opportunity to advance both services and science of mental health in Tajikistan.
Aim 1. To assess the effectiveness of the stepped care model with 420 women who have depression and potential co-occurring anxiety, recruited from 12 primary care clinics in Tajikistan, compared with standard of care plus provision of healthy lifestyle materials, with another 210 women recruited from 6 primary care clinics, including assessing mediators and moderators (e.g. executive control efficiency, trauma exposure).
Aim 2. To assess whether a clinic implementation team moderates women's reduction in depression post-intervention, as well as clinic-level (leadership support and degree of implementation) and provider-level (motivation and fidelity) moderators.
Aim 3. To establish a national mental health research network that focuses on improving the standard of mental health care and access to services by building mental health implementation research capacity.
- Conditions
- Depression, Anxiety
- Being tested
- Stepped Care, Standard of Care plus Healthy Lifestyle
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped CareBehavioural
This stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline.
Standard of Care plus Healthy LifestyleBehavioural
Standard outpatient care supplemented with literature on healthy lifestyles will serve as an enhanced control condition. In each clinic, non-specialty mental health care is available in the form of counseling from doctors or nurses along with psychiatric medication management. Given the difficulties faced by women in Tajikistan, ethical responsibility compels us to enhance the control condition by having nurses distribute written materials on healthy eating, physical fitness, and personal hygiene, at a reading level which will be widely accessible.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care | Experimental | To assess the effectiveness of the stepped care model with 420 women who have depression and potential co-occurring anxiety, recruited from 12 primary care clinics in Tajikistan. Receives: Behavioral: Stepped Care |
| Standard of Care plus Healthy Lifestyle | Active comparator | To compare standard of care plus healthy lifestyle materials with 210 women recruited from 6 primary care clinics in Tajikistan. Receives: Behavioral: Standard of Care plus Healthy Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HAM-D) is a way of determining a patient's level of depression before, during, and after treatment. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Score of 0-7 = normal; 8-13 = mild depression; 14-18 = moderate depression; 19-22 = severe depression, +23 = very severe depression.
Measured: baseline, 3 months, 6 months, and 12 months
change in Texas Christian University (TCU) Organizational Readiness for Change
Motivational factors include program needs, training needs, and pressures for change, while program resources are evaluated in regard to office facilities, staffing, training, equipment, and the Internet. Organizational dynamics include scales on staff attributes and climate.
Numbers for each item indicate its location in the administration version, in which response categories are 1=Strongly Disagree to 5=Strongly Agree; ® designates items with reflected scoring. Scores for each scale are obtained by summing responses to its set of items (after reversing scores on reflected items by subtracting the item response from "6"), dividing the sum by number of items included (yielding an average) and multiplying by 10 in order to rescale final scores so they range from 10 to 50 (e.g., an average response of 2.6 for a scale becomes a score of "26").
Measured: baseline, 3 months, 6 months, and 12 months
Secondary outcomes (4)
change in Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale (HAM-A) measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
Measured: baseline, 3 months, 6 months, and 12 months
change in PTSD Checklist for DSM- 5
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment, screening individuals for PTSD, making a provisional PTSD diagnosis.Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point Likert scale ranging from 0 not at all, 1 a little bit, 2 moderately, 3 quite a bit, 4 extremely. Items are summed to provide a total severity score (range = 0-80).Summing all 20 items and using cut-point score of 33 appears to be reasonable based upon current psychometric work.
Measured: baseline, 3 months, 6 months, and 12 months
change in Evidence Based Practice Attitude Scale
This tool (EBPAS) examines attitudes toward evidence-based practice among social service providers. The tool includes 15 questions regarding clinician and case manager willingness to adopt evidence-based practices given the appeal of evidence-based practice, system, organization, or supervisor requirements for evidence-based practices. The four scales are labeled as "Requirements scale" (3 items), "Appeal scale" (4 items), "Openness scale" (4 items), "Divergence scale" (4 items). A higher score indicates "more" of the scale name, except for Divergence
Measured: baseline, 3 months, 6 months, and 12 months
# Stepped Care interventions initiated and completed
Measure the number of stepped care interventions that were initiated and those that were completed.
Measured: baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start14 Aug 2020
- Primary completion1 Apr 2023
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Research Center, University of Utah, New York University
- Responsible party
- Principal investigator, Stevan Weine, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110405
- Sponsor's protocol ID
- 2019-0745
- Status last verified
- Jun 2023
- First submitted
- 18 Sep 2019
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC
- ClinicalTrials.gov ID
- NCT04110405
- Acronym / sponsor ID
- 2019-0745
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Prisma Research Center, University of Utah, New York University
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Oct 2019 (actual)
- 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 examines: 1) short-term and longitudinal impacts of stepped care on women with depression and the possible roles of mediators and moderators; 2) clinic- (readiness to adopt an innovation, leadership support and climate) and provider-level (preparedness, motivation and fidelity) factors that may affect stepped care implementation; and 3) the differential impact of two implementation approaches (a clinic implementation teams versus implementation training by the research team). It utilizes Curran's hybrid effectiveness implementation design, mixed methods, and a longitudinal design with assessments at pre, 3 months, 6 months, and 12 months. A total of 18 primary care clinics, set in both rural and urban communities in Tajikistan, will be involved, with 12 delivering the intervention and 6 acting as controls. 8 providers (3 nurses, 3 peers, and 2 doctors) will be recruited at each of the 12 intervention clinics for a total of 96 providers; 35 women with depression will be recruited from each clinic for a total of 630 women.
Detailed description
This research will advance mental healthcare task sharing in effectiveness and implementation testing of a stepped care model for LMICs. It uses nurses and mental health peers to treat depression and potential co-occurring anxiety among women in primary care. The study addresses Grand Challenges in Global Mental Health Goal C to foster integration of mental health into primary care and NIMH Strategic Aim 3 by developing new and better interventions that incorporate the diverse needs and circumstances of people with mental illness. It utilizes Curran's hybrid effectiveness implementation design. To improve implementation, it examines the impact of clinic implementation teams in readying the clinic and service providers. Additionally, it explores how RDoC neuroscience contributes to implementation science through enhancing the evaluation and targeting of stepped care. This study will enable new collaborative research activities, in tandem with network building, mentorship and training, and dissemination of findings, which will further build the LMIC capacity for implementation science research and development of evidence-based medicine by strengthening Tajikistan's individual and institutional research capabilities.
Globally, young women bear a disproportionate burden of common mental disorders, and especially including depression and potentially co-occurring anxiety. With current care models, this burden cannot be lifted without finding ways to deliver mental health prevention and treatment services and illness self-management to women in primary care. Our previous research in Tajikistan has demonstrated that women are exposed to serious risks for mental illness, and how peers and primary care nurses have played major but largely informal roles in helping women with mental health problems. Therefore, the investigators developed and tested for feasibility a stepped care model which showed very strong treatment effects. This stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline.
This project will scale-up the intervention in multiple polyclinics, so as to examine its effectiveness (Aim 2) and to compare two implementation strategies (Aim 3). This presents a remarkable opportunity to advance both services and science of mental health in Tajikistan.
Aim 1. To assess the effectiveness of the stepped care model with 420 women who have depression and potential co-occurring anxiety, recruited from 12 primary care clinics in Tajikistan, compared with standard of care plus provision of healthy lifestyle materials, with another 210 women recruited from 6 primary care clinics, including assessing mediators and moderators (e.g. executive control efficiency, trauma exposure).
Aim 2. To assess whether a clinic implementation team moderates women's reduction in depression post-intervention, as well as clinic-level (leadership support and degree of implementation) and provider-level (motivation and fidelity) moderators.
Aim 3. To establish a national mental health research network that focuses on improving the standard of mental health care and access to services by building mental health implementation research capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care | Experimental | Behavioral: Stepped CareTo assess the effectiveness of the stepped care model with 420 women who have depression and potential co-occurring anxiety, recruited from 12 primary care clinics in Tajikistan. |
| Standard of Care plus Healthy Lifestyle | Active comparator | Behavioral: Standard of Care plus Healthy LifestyleTo compare standard of care plus healthy lifestyle materials with 210 women recruited from 6 primary care clinics in Tajikistan. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female Tajik citizen between 18 and 45 years old
- score >16 on the HAM-D
- no current or past substance use
- willing to participate in the intervention and research procedures
- able to give written informed consent.
Key exclusion criteria (2 listed)
- women who are older or younger than 18 - 45 years
- women who do not score >16 on the HAM-D
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 |
|---|---|---|
| Stepped CareThis stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline. | Behavioural | Stepped Care |
| Standard of Care plus Healthy LifestyleStandard outpatient care supplemented with literature on healthy lifestyles will serve as an enhanced control condition. In each clinic, non-specialty mental health care is available in the form of counseling from doctors or nurses along with psychiatric medication management. Given the difficulties faced by women in Tajikistan, ethical responsibility compels us to enhance the control condition by having nurses distribute written materials on healthy eating, physical fitness, and personal hygiene, at a reading level which will be widely accessible. | Behavioural | Standard of Care plus Healthy Lifestyle |
Primary outcome
change in Hamilton Depression Rating Scale
Time frame: baseline, 3 months, 6 months, and 12 months
The Hamilton Depression Rating Scale (HAM-D) is a way of determining a patient's level of depression before, during, and after treatment. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Score of 0-7 = normal; 8-13 = mild depression; 14-18 = moderate depression; 19-22 = severe depression, +23 = very severe depression.
change in Texas Christian University (TCU) Organizational Readiness for Change
Time frame: baseline, 3 months, 6 months, and 12 months
Motivational factors include program needs, training needs, and pressures for change, while program resources are evaluated in regard to office facilities, staffing, training, equipment, and the Internet. Organizational dynamics include scales on staff attributes and climate. Numbers for each item indicate its location in the administration version, in which response categories are 1=Strongly Disagree to 5=Strongly Agree; ® designates items with reflected scoring. Scores for each scale are obtained by summing responses to its set of items (after reversing scores on reflected items by subtracting the item response from "6"), dividing the sum by number of items included (yielding an average) and multiplying by 10 in order to rescale final scores so they range from 10 to 50 (e.g., an average response of 2.6 for a scale becomes a score of "26").
4 secondary outcomes
change in Hamilton Anxiety Rating Scale
Time frame: baseline, 3 months, 6 months, and 12 months
change in PTSD Checklist for DSM- 5
Time frame: baseline, 3 months, 6 months, and 12 months
change in Evidence Based Practice Attitude Scale
Time frame: baseline, 3 months, 6 months, and 12 months
# Stepped Care interventions initiated and completed
Time frame: baseline, 3 months, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care in people with Depression and Anxiety, run by University of Illinois Chicago at 20 sites in Tajikistan.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Tajikistan. 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?
Results are not available in the source record.
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?
change in Hamilton Depression Rating Scale (time frame: baseline, 3 months, 6 months, and 12 months). 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 27 Jun 2023.