Depression in Old AgeINDIGONCT06125899
Protocol for a Feasibility Cluster Randomised Controlled Trial of a Home-based Depression Care for Older People Delivered by Lay Providers in Nigeria
A study testing emhGAP-Age in people with Depression in Old Age, run by University of Ibadan.
Trial summary
The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- emhGAP-Age
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jul 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years,
- PHQ-9 score of ≥11 during routine consultation
Who cannot join
- Severe co-morbidity requiring urgent attention.
- Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
- Active suicidal intention.
- Evidence of bipolar/psychosis/severe substance use disorders.
- Planning to move out of the study catchment area within 6 months.
- Refusing/lacking capacity to consent/accent
About this study
Official title: Intervention for Depression in Underserved Geriatric Populations
The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with depression. The main questions it aims to answer are:
- Whether the emhGAP-Age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial?
- What are the logistical, programmatic, and operational requirements for a home-delivered emhGAP-Age in a sample of older people with depression in Nigeria? Consenting older participants with depression in the intervention arm will receive treatment based on emhGAP-Age which consists of;
- Adapted electronic generic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG)
- Adapted Problem-Solving Therapy (PST-PC)
- Support/supervision of providers
- Links to social support resources. Researchers will compare with treatment based on the basic specification in the generic emhGAP-IG (consisting of basic psychoeducation and stress reduction) for effects on depression remission.
- Conditions
- Depression in Old Age
- Being tested
- emhGAP-Age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emhGAP-AgeBehavioural
- Adapted emhGAP-IG;
- Adapted Problem-Solving Therapy (PST-PC)
- Support/supervision of lay providers
- Links to social support resources.
| Study group | Role | What they receive |
|---|---|---|
| Age emhGAP-IG | Experimental | * Adapted emhGAP-IG;
* Adapted Problem-Solving Therapy (PST-PC)
* Support/supervision of lay providers
* Links to social support resources. Receives: Behavioral: emhGAP-Age |
| Generic emhGAP-IG | Active comparator | Psychoeducation and stress reduction Receives: Behavioral: emhGAP-Age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression remission
Patient Health Questionnaire (PHQ-9) score < 6
Measured: At six months post trial entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startFeb 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akin Ojagbemi, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125899
- Sponsor's protocol ID
- 220684/Z/20/Z
- Acronym
- INDIGO
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Depression in Underserved Geriatric Populations
- ClinicalTrials.gov ID
- NCT06125899
- Acronym / sponsor ID
- INDIGO / 220684/Z/20/Z
- Conditions
- Depression in Old Age
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Nov 2023 (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.
The aim of this hybrid (Effectiveness-Implementation) cluster randomised controlled clinical trial is to test the feasibility of implementing an age-appropriate electronic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-Age) in routine home-based care of older Nigerians with depression. The main questions it aims to answer are:
- Whether the emhGAP-Age demonstrate sufficient signals of effectiveness in the identification and home management of late life depression to permit for further exploration in a fully powered clinical trial?
- What are the logistical, programmatic, and operational requirements for a home-delivered emhGAP-Age in a sample of older people with depression in Nigeria? Consenting older participants with depression in the intervention arm will receive treatment based on emhGAP-Age which consists of;
- Adapted electronic generic version of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG)
- Adapted Problem-Solving Therapy (PST-PC)
- Support/supervision of providers
- Links to social support resources. Researchers will compare with treatment based on the basic specification in the generic emhGAP-IG (consisting of basic psychoeducation and stress reduction) for effects on depression remission.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age emhGAP-IG | Experimental | Behavioral: emhGAP-Age* Adapted emhGAP-IG; * Adapted Problem-Solving Therapy (PST-PC) * Support/supervision of lay providers * Links to social support resources. |
| Generic emhGAP-IG | Active comparator | Behavioral: emhGAP-AgePsychoeducation and stress reduction |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 60 years,
- PHQ-9 score of ≥11 during routine consultation
Key exclusion criteria (6 listed)
- Severe co-morbidity requiring urgent attention.
- Severe cognitive impairment/dementia (Community Screening Instruments for Dementia score≤ 20) .
- Active suicidal intention.
- Evidence of bipolar/psychosis/severe substance use disorders.
- Planning to move out of the study catchment area within 6 months.
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 |
|---|---|---|
| emhGAP-Age* Adapted emhGAP-IG; * Adapted Problem-Solving Therapy (PST-PC) * Support/supervision of lay providers * Links to social support resources. | Behavioural | Age emhGAP-IG, Generic emhGAP-IG |
Primary outcome
Depression remission
Time frame: At six months post trial entry
Patient Health Questionnaire (PHQ-9) score < 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing emhGAP-Age in people with Depression in Old Age, run by University of Ibadan.
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 2 inclusion and 6 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Depression remission (time frame: At six months post trial entry). 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 9 Nov 2023.