Clinical trial NCT02232854: Training and Supervision Program for Depression Management
Official title: Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2014-09-05
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: According to the literature the management of depressive disorders at primary care level is not always consistent with guidelines. The main objective of this study is to test whether a Comprehensive Technology-Assisted Training and Supervision Program will improve depression management in Primary Health Care clinics in Santiago, Chile.

Detailed description: A cluster randomized controlled clinical trial will be conducted in four Primary Health Care (PHC) clinics in Santiago, Chile.

The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a high Human Development Index, high percentage of immigrants and older population, and Psychiatry residents working in PHC , will be excluded.Secondly in each selected municipalities,two PHC will be randomly selected for the active and control arm.

To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. A design effect of 2.42 was estimated. After applying the design effect the sample needed increased to 368 depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics.

Analysis and presentation of the results will be in accordance with CONSORT guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons.

Initially descriptive analysis to assess the balance between two groups will be conducted. The primary analysis will employ multilevel multivariable lineal regression to investigate differences in the PHQ-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. Sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. Similar analysis will be done for the secondary outcomes measures.

Eligibility criteria: Inclusion Criteria:

* signing written informed consent
* age between 18-65 years
* current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* current depression treatment
* no access to telephone

Primary outcomes:
measure: Change from Baseline Depressive Symptomatology at 3 months
timeFrame: Baseline , 3 months
measure: Change from Baseline Depressive Symptomatology at 6 months
timeFrame: Baseline, 6 months.
Secondary outcomes:
measure: Adherence to depression treatment at patient's level
timeFrame: 3 and 6 months after baseline.
measure: Change from Baseline Quality of life at 3 and 6 months
timeFrame: Baseline , 3 months, 6 months.
measure: Change from Baseline Clinical Outcomes at 3 and 6 months
timeFrame: Baseline , 3 months, 6 months.
measure: Use of Health Care services at patient's level
timeFrame: 3 and 6 months after baseline
measure: Rate of treated depressed cases at Primary Care team level
timeFrame: 12 months before randomization and 12 months after.
Other outcomes:
Locations:
city: Quinta Normal
country: Chile
facility: CESFAM Garín
state: Santiago
city: Quinta Normal
country: Chile
facility: CESFAM Lo Franco
state: Santiago
city: San Miguel
country: Chile
facility: CESFAM Barros Luco
state: Santiago
city: San Miguel
country: Chile
facility: CESFAM Recreo
state: Santiago
Study officials:
References:
citation: Rojas G, Martinez P, Vohringer PA, Martinez V, Castro-Lara A, Fritsch R. Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial. Trials. 2015 Jul 24;16:311. doi: 10.1186/s13063-015-0845-4.