DepressionNCT02232854
Training and Supervision Program for Depression Management
A study testing Depression training/supervision program in people with Depression, run by University of Chile at 4 sites in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Depression training/supervision program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 4 sitesChile
- Study dates
- Apr 2014to Jun 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signing written informed consent
- age between 18-65 years
- current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)
Who cannot join
- current depression treatment
- no access to telephone
Trial locations and contacts
4 sites in 1 country.
Chile4 sites
CESFAM Garín
Quinta Normal, Santiago Metropolitan
CESFAM Lo Franco
Quinta Normal, Santiago Metropolitan
CESFAM Barros Luco
San Miguel, Santiago Metropolitan
CESFAM Recreo
San Miguel, Santiago Metropolitan
About this study
Official title: Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Depression training/supervision program
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depression training/supervision programBehavioural
The intervention will be composed of:
- Training of Primary Health Care teams to ensure compliance to the "Clinical Guidelines of the Ministry of Health for the Treatment of Depression". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.
- After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.
- Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.
- Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Depression training/supervision program | Experimental | A complex intervention, which will include:
* Primary Health Care team training in depression
* A focus group, after training
* Telephone monitoring of patients
* Web-based supervision of clinicians Receives: Behavioral: Depression training/supervision program |
| Usual Care | No intervention | Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Depressive Symptomatology at 3 months
Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
Measured: Baseline , 3 months
Change from Baseline Depressive Symptomatology at 6 months
Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.
Measured: Baseline, 6 months.
Secondary outcomes (5)
Adherence to depression treatment at patient's level
Measured: 3 and 6 months after baseline.
Change from Baseline Quality of life at 3 and 6 months
Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.
Measured: Baseline , 3 months, 6 months.
Change from Baseline Clinical Outcomes at 3 and 6 months
Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2), at 3 months and 6 months after patient recruitment.
Measured: Baseline , 3 months, 6 months.
Use of Health Care services at patient's level
Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.
Measured: 3 and 6 months after baseline
Rate of treated depressed cases at Primary Care team level
Measured: 12 months before randomization and 12 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graciela Rojas Castillo, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232854
- Sponsor's protocol ID
- 1130230
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2014
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26201546
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
- ClinicalTrials.gov ID
- NCT02232854
- Acronym / sponsor ID
- 1130230
- Conditions
- Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Sep 2014 (estimated)
- 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.
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.
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 |
|---|---|---|
| Depression training/supervision program | Experimental | Behavioral: Depression training/supervision programA complex intervention, which will include: * Primary Health Care team training in depression * A focus group, after training * Telephone monitoring of patients * Web-based supervision of clinicians |
| Usual Care | No intervention | –Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signing written informed consent
- age between 18-65 years
- current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)
Key exclusion criteria (2 listed)
- current depression treatment
- no access to telephone
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 |
|---|---|---|
| Depression training/supervision programThe intervention will be composed of: * Training of Primary Health Care teams to ensure compliance to the "Clinical Guidelines of the Ministry of Health for the Treatment of Depression". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation. * After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation. * Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence. * Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment. | Behavioural | Depression training/supervision program |
Primary outcome
Change from Baseline Depressive Symptomatology at 3 months
Time frame: Baseline , 3 months
Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
Change from Baseline Depressive Symptomatology at 6 months
Time frame: Baseline, 6 months.
Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.
5 secondary outcomes
Adherence to depression treatment at patient's level
Time frame: 3 and 6 months after baseline.
Change from Baseline Quality of life at 3 and 6 months
Time frame: Baseline , 3 months, 6 months.
Change from Baseline Clinical Outcomes at 3 and 6 months
Time frame: Baseline , 3 months, 6 months.
Use of Health Care services at patient's level
Time frame: 3 and 6 months after baseline
Rate of treated depressed cases at Primary Care team level
Time frame: 12 months before randomization and 12 months after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 26201546Rojas 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.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depression training/supervision program in people with Depression, run by University of Chile at 4 sites in Chile.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Depressive Symptomatology at 3 months (time frame: Baseline , 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232854, which also lists 1 linked publication.
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 25 Oct 2017.