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A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE Study

A collaborative care psychosocial intervention to improve late life depression according to PHQ-9 in depressed elderly people living in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57805470
Enrollment
1140
Registered
2019-04-25
Start date
2019-05-06
Completion date
Unknown
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in older adults. Mental and Behavioural Disorders

Interventions

Interventions will include a psychosocial intervention (intervention group) and enhanced usual care (control group). “Enhanced” usual care This comprises improved reco
• Collaborative care: the CHW will work collaboratively with all other members from their FHT to deliver the intervention
• Stepped care: the intensity of care management is tailored according to needs. Those who need more receive more and vice versa. The FHT will decide if the participant needs further s

Sponsors

Universidade de Sao Paulo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals 60 years or older registered with the selected FHTs will be screened following a randomly ordered list of names 2. Only those with a 9-item Patient Health Questionnaire (PHQ-9) score 10 or above, a threshold for depression, will be eligible for inclusion in the study

Exclusion criteria

Exclusion criteria: 1. Partner or another person that lives in the same household has already been included in the study 2. Acute suicidal risk in response to the PHQ-9 and the additional suicidal risk questionnaire 3. Completely deaf 4. Unable to communicate (non-native speaker, cognitive impairment and psychotic symptoms) 5. Unable to engage in the trial for the period of 12 months (terminal illness, partner with terminal illness, plans to move out to another area)

Design outcomes

Primary

MeasureTime frame
Proportion of depression recovery (PHQ-9<10) at 8 months follow-up in the intervention compared to the control group.

Secondary

MeasureTime frame
1. Proportion with depression recovery (PHQ-9<10) at 12 months will assess the maintenance of any earlier clinical gains. The following additional secondary measures will be completed at 8 and 12 months and compared between the two arms: 2. European Quality of Life five-dimensional questionnaire, Five-level version (EQ-5D-5L) 3. ICEpop CAPability measure for Older people (ICECAP-O) 4. Behavioural Activation for Depression Scale (BADS) 5. Stressful life events (SLE); General Anxiety Disorder-7 (GAD-7) 6. Lubben Social Network Scale-6 (LSNS-6) 7. Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) 8. Loneliness Scale (3-item UCLA) 9. We will assess the cost-effectiveness of the intervention at 12 months.

Countries

Brazil

Contacts

Public ContactMarcia Scazufca
scazufca@usp.br+55 11 26617268

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026