A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE Study
- Conditions
- Depression in older adults.Mental and Behavioural Disorders
- Registration Number
- ISRCTN57805470
- Lead Sponsor
- niversidade de Sao Paulo
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33153482/ protocol (added 09/11/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36202129/ Primary outcome data (added 25/11/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1140
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of depression recovery (PHQ-9<10) at 8 months follow-up in the intervention compared to the control group.
- Secondary Outcome Measures
Name Time Method <br> 1. Proportion with depression recovery (PHQ-9<10) at 12 months will assess the maintenance of any earlier clinical gains.<br> The following additional secondary measures will be completed at 8 and 12 months and compared between the two arms:<br> 2. European Quality of Life five-dimensional questionnaire, Five-level version (EQ-5D-5L)<br> 3. ICEpop CAPability measure for Older people (ICECAP-O)<br> 4. Behavioural Activation for Depression Scale (BADS)<br> 5. Stressful life events (SLE); General Anxiety Disorder-7 (GAD-7)<br> 6. Lubben Social Network Scale-6 (LSNS-6)<br> 7. Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)<br> 8. Loneliness Scale (3-item UCLA)<br> 9. We will assess the cost-effectiveness of the intervention at 12 months.<br>