Assessment of a psychosocial intervention to prevent depression and anxiety in elderly people who attend primary health care centers
| ISRCTN | ISRCTN32235611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32235611 |
| Secondary identifying numbers | FONDECYT 1171732 |
- Submission date
- 07/07/2018
- Registration date
- 25/07/2018
- Last edited
- 21/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
An effective way of decreasing depression and anxiety and promoting wellbeing in the elderly is using psychosocial interventions. However, there has been no evidence of this in Latin America.
This study aims to assess a program in Chile that has been specifically designed to decrease symptoms of depression and anxiety and promote psychological wellbeing in self-reliant, elderly people who attend primary health care centres.
Who can participate?
Self-reliant 65-80 year olds who attend primary health care centres
What does the study involve?
Participants will be randomly assigned to either the intervention or control group.
Participants in the intervention group will take part in a 12 week program, consisting of 9 weekly 2 hour sessions, 2 phone calls and a week with no activities (week 11). Activities relate to the care of physical and mental health, including cognitive training, expansion of social support networks and behavioural strategies for the management and prevention of depression and anxiety symptoms. There will be training in relaxation, encouragement to develop activities that help participants to feel better and analysis of worries and loss experiences. Participants will be assessed before the intervention, and 18 and 36 weeks after the intervention on symptoms related to depression and anxiety, and psychological wellbeing.
Participants in the control group will receive passive education through a leaflet, and will receive the 12 week intervention program once the intervention group complete this program and their post-intervention activities.
What are the possible benefits and risks of participating?
The possible benefit of participating in this study is that the program is designed to decrease symptoms of depression and anxiety and promote wellbeing, which could have a positive effect on participants' mental health. There are no known risks of participating in this study.
Where is the study run from?
The study will be run in 15 primary care centers in the province of Concepcion, Chile.
When is the study starting and how long is it expected to run for?
March 2017 to December 2019
Who is funding the study? (who will be paying the costs that the trial will incur during its lifecycle?)
FONDECYT Comisión Nacional de Ciencia y Tecnología (Chile)
Who is the main contact?
Sandra Saldivia
saldivi@udec.cl
Contact information
Public
Facultad de Medicina, Dpto. de Psiquiatría, Universidad de Concepcion
Concepción
4030000
Chile
 ORCID ID |
0000-0002-7594-7069 |
|---|---|
| Phone | 56-41-2204299 |
| ssaldivi@udec.cl |
Study information
| Study design | Interventional multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Assessment of a psychosocial intervention to prevent depression and anxiety in elderly people who attend primary health care centers: A clinical randomized trial |
| Study acronym | Vida Activa |
| Study objectives | In elderly people who attend primary health care centers and with no current mental health disorder, a brief group psychosocial intervention decreases depressive and anxious symptomatology and increases subjective well-being, indicating promotional effects and possible preventive effects in regards to the development of depressive and anxious disorders and improve psychological well-being. |
| Ethics approval(s) | The study was approved by the Ethics Committee of Health Services of Concepcion (Resolution from 04/03/2018, code CEC 17-09-53) and Talcahuano (Assessment Act 66 from 07/04/2017)., Chile. |
| Health condition(s) or problem(s) studied | Depression and anxiety |
| Intervention | Those who accept the invitation to participate in the study will receive the initial assessment and those who meet participant exclusion criteria will be identified. The initial assessment includes socio-demographics, mental health (depression and anxiety symptoms and depression and anxiety diagnosis according to DSM-IV criteria, and alcohol use) and subjective wellbeing. This will be carried out at the participants' homes by trained interviewers. From this, those who meet the inclusion criteria will be used to generate the final list of participants, which will then be subject to block randomization by an external statistician with no connection to the participant assessment process. Each health care center in the study will be a block. The intervention program is a twelve-week group program, consisting of two hour sessions once per week. The program includes activities that care for physical and mental health, including cognitive training, social support network and cognitive behavioural strategies that have been shown to be effective for therapeutic and preventative management of depression and anxiety symptoms. Specifically, these include training in relaxation, behavioral action, along with cognitive analysis and re-evaluation related to topics of worry and loss. The program is carried out by a psychologist and trained health worker, both of whom receive previous training and must pass a competence test. They will be both personally and distance-supervised on a weekly basis. The control group will receive passive psycho-education using a leaflet. |
| Intervention type | Behavioural |
| Primary outcome measure | Depressive symptomatology will be assessed using the Patient Health Questionnaire (PHQ-9) (Baader et al., 2012; Kroenke, Spitzer, & Williams, 2001) before the intervention (pretest 3-4 weeks prior to the intervention), 18 weeks after the intervention (first post test) and 36 weeks after the intervention (second post test). |
| Secondary outcome measures | The following will be assessed before the intervention (pretest 3-4 weeks prior to the intervention), 18 weeks after the intervention (first post test) and 36 weeks after the intervention (second post test): 1. Anxiety symptomatology will be assessed with the anxiety subscale of the Symptom Check List (SCL-90-R) (Derogatis & Cleary, 1977; Gempp & Avendaño, 2008) 2. Depressive disorder will be assessed using Module E of the Composite International Diagnostic Interview (CIDI 2.1) (WHO, 1997) 3. Anxiety disorder (panic disorder and generalized anxiety disorder) will be assessed using the anxious disorders section of the Mini-International Neuropsychiatry Interview (MINI) (Sheehan, Lecrubier, Sheehan, Amorim, Janavs et al., 1999, Ferrando, Franco- Alfonso, Soto, Bobes García, Soto et al., 2000). 4. Psychological wellbeing will be assessed using the Pemberton Happiness Index (Hervás & Vázquez, 2013) |
| Overall study start date | 01/03/2017 |
| Completion date | 30/12/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 170 per condition |
| Total final enrolment | 538 |
| Key inclusion criteria | 1. Aged 65-80 years 2. Self-reliant 3. Health center user |
| Key exclusion criteria | 1. Diagnosis of common psychiatric disorder (e.g. depressive or anxiety disorder) 2. Diagnosis of severe mental disorder 3. Physical disability 4. Disability that limits and/or prevents communication |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- Chile
Study participating centres
Talcahuano
4260000
Chile
Talcahuano
4260000
Chile
Talcahuano
4260000
Chile
Talcahuano
4260000
Chile
Hualpen
4600000
Chile
Hualpen
4600000
Chile
Hualpen
4600000
Chile
Chiguayante
4100000
Chile
Chiguayante
4100000
Chile
Chiguayante
4100000
Chile
Concepción
4030000
Chile
Concepción
4030000
Chile
Concepción
4030000
Chile
Concepción
4030000
Chile
Concepción
4030000
Chile
Sponsor information
University/education
Victor Lamas 1290
Concepcion
4030000
Chile
| Phone | 56-41-2204302 |
|---|---|
| rmennick@udec.cl | |
| Website | www.udec.cl |
"ROR" |
https://ror.org/0460jpj73 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The data sets generated and/or analysed during the current study are/will be available upon request from Sandra Saldivia (ssaldivi@udec.cl). The raw data will be available in SPSS database format. Processed data will be available in R. The data will be available after the study is completed in December 2019. Data will be available only for private reanalyses to be used in an interested research and for two months. There will be no way to identify the participants of the program from the data used. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/08/2019 | 30/08/2019 | Yes | No |
| Basic results | 10/08/2020 | 21/08/2020 | No | No |
Additional files
- ISRCTN32235611_BasicResults_10Aug20.pdf
- Uploaded 21/08/2020
Editorial Notes
21/08/2020: The basic results of this trial have been uploaded as an additional file. Total final enrolment number added.
30/08/2019: Publication reference added.
