DepressionNCT04613076
Technology-assisted Collaborative Care Program for Depressed Patients With Chronic Disease at Primary Care
A study testing "Me cuido y me siento mejor" and Enhanced Usual Treatment in people with Depression, run by University of Chile at 1 site in Chile.
Trial summary
Background: depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- "Me cuido y me siento mejor" and Enhanced Usual Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 1 siteChile
- Study dates
- 3 Sep 2019to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Enrolled in the Cardiovascular Health Program (i.e. currently receiving treatment for diabetes and/or hypertension) at the study primary care clinics.
- Patient Health Questionnaire-9 Item (PHQ-9) score ≥ 15.
- Signed informed consent.
Who cannot join
- Functional illiteracy (i.e., patients unable to read and comprehend written information, such as the study questionnaires or written informed consent).
- Significant visual and/or auditive impairments (i.e., such as those imposing a serious difficulty to respond the study questionnaires or written informed consent).
- Pregnancy or breastfeeding.
- Cognitive impairment - ineligible patients would give a negative answer to questions "What year is it?" and "Where are we (place/address)?".
- In treatment for bipolar and/or psychotic disorder.
- Current psychological treatment for depression.
- High risk of developing alcohol/substance abuse problems, according to an Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) score ≥ 27.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Collaborative, Computer-assisted, Psycho-educational Intervention for Depressed Patients With Chronic Disease at Primary Care
Background: depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile.
Methods: two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item [PHQ-9] scores ≥ 15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at three, six, and twelve months after enrollment. The primary outcome will be depression improvement at six months, defined as ≥ 50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed.
- Conditions
- Depression
- Being tested
- "Me cuido y me siento mejor", Enhanced Usual Treatment
- Keywords
- Cluster Randomized Controlled Trial, Depression, Hypertension, Diabetes, Primary Care, Psychotherapy, Cognitive-Behavioral
- Medical subject headings
- Depression, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Me cuido y me siento mejor"Behavioural
A multicomponent, collaborative, computer-assisted, psycho-educational intervention for the management of depressive symptoms in primary care patients with diabetes and/or hypertension.
Enhanced Usual TreatmentBehavioural
Enhanced Usual Treatment
| Study group | Role | What they receive |
|---|---|---|
| "Me cuido y me siento mejor" | Experimental | Patients in the primary care clinics assigned to the intervention will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists; structured telephone calls by social worker to monitor clinical progress and treatment adherence; usual medical care for chronic diseases; and access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles. Study therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Receives: Behavioral: "Me cuido y me siento mejor" |
| Enhanced Usual Treatment | Active comparator | The patients in the primary care clinics assigned to the comparator will receive the usual treatment for depression and their physical conditions -all the guaranteed interventions for people with depression, hypertension, and/or diabetes in primary care, according to the Clinical Guidelines for the Treatment of Depression- and their associated basket of health benefits included in the Regime of Explicit Health Care Guarantees. They will have access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles. Receives: Behavioral: Enhanced Usual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression change
Defined as a 50% reduction in a participant's Patient Health Questionnaire-9 Item (PHQ-9) score compared to the baseline.
The PHQ-9 minimum and maximum values are 0 and 27 points. Higher scores mean worse outcomes.
Measured: Even though the primary outcome is taken at six-month follow-up, this measure will also be reported at three- and twelve-month follow-up.
Secondary outcomes (6)
Proportion of patients who change their depressive status
Defined as a change in a patient's depressive status from an initial score above the cutoff (PHQ-9 ≥ 10) and a follow-up score below this reference value (PHQ-9 < 10).
Measured: Three-, six-, and twelve-month follow-up.
Health-related quality of life
Defined as a patient's score on the scales and main components of the Short-Form 12 Health Survey (SF-12).
The SF-12 minimum and maximum values are 0 and 100 points. Higher scores mean better outcomes.
Measured: Three-, six-, and twelve-month follow-up.
Social solving problem skills
Defined as a patient's score on the Positive Problem Orientation and Rational Problem Solving Style subscales of the Social Problem-Solving Inventory - Revised Short Form (SPSI-R:S).
The SPSI-R:S minimum and maximum values are 0 and 100 points. Higher scores on the Positive Problem Orientation and the Rational Problem Solving Style, and lower scores on the Negative Problem Orientation, Impulsivity/Carelessness Style, and Avoidance Style mean better outcomes.
Measured: Three-, six-, and twelve-month follow-up.
Proportion of participants with change in blood pressure
Defined as the achievement of therapeutic goal in the normalization of blood pressure according to the national standards established in the Clinical Guidelines of Primary or Essential Arterial Hypertension in people aged 15 or older. The therapeutic goal is to attain a value lower than 140/90 mmHg in non-diabetic patients and lower than 130/80 mmHg in patients with very high cardiovascular risk, diabetes, and/or proteinuric nephropathy. These values will be obtained from the patients' clinical records.
Measured: Three-, six-, and twelve-month follow-up.
Ad-hoc questionnaire for the assessment of the acceptability of depression treatment
The ad-hoc instrument for evaluating the acceptability of the interventions is a self-report questionnaire that consists in 12 Likert-type items with four answer choices ranging from 1 (strongly agree) to 4 (strongly disagree). The construction of this instrument was based on the theoretical framework of acceptability, proposed by Sekhon et al., which characterizes seven dimensions for this concept: ethicality, affective attitude, burden, opportunity costs, perceived effectiveness, self-efficacy, and intervention coherence. For their interpretation, the participants' scores will be transformed into percentages (0% to 100%), with higher values representing more intervention acceptability.
Measured: Three-, six-, and twelve-month follow-up.
Proportion of participants with change in glycosylated hemoglobin
Defined as the achievement of glycemic control, according to the national standards established in the Clinical Guidelines for Type II Diabetes Mellitus. Maintaining levels of glycosylated hemoglobin below 7% is regarded as a therapeutic goal in type II diabetes mellitus. These values will be obtained from the patients' clinical records.
Measured: Three-, six-, and twelve-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start3 Sep 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, Graciela Rojas Castillo, University of Chile
- Investigators
- Graciela Rojas, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613076
- Sponsor's protocol ID
- 1180224
- Status last verified
- Dec 2023
- First submitted
- 21 Oct 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rojas G, Martinez P, Guajardo V, Campos S, Herrera P, Vohringer PA, Gomez V, Szabo W, Araya R. A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial. BMC Psychiatry. 2021 Aug 21;21(1):418. doi: 10.1186/s12888-021-03380-2.
PubMed 34419010
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative, Computer-assisted, Psycho-educational Intervention for Depressed Patients With Chronic Disease at Primary Care
- ClinicalTrials.gov ID
- NCT04613076
- Acronym / sponsor ID
- 1180224
- Conditions
- Depression
- Keywords
- Cluster Randomized Controlled Trial, Depression, Hypertension, Diabetes, Primary Care, Psychotherapy, Cognitive-Behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- 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.
Background: depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile.
Methods: two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item [PHQ-9] scores ≥ 15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at three, six, and twelve months after enrollment. The primary outcome will be depression improvement at six months, defined as ≥ 50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Me cuido y me siento mejor" | Experimental | Behavioral: "Me cuido y me siento mejor"Patients in the primary care clinics assigned to the intervention will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists; structured telephone calls by social worker to monitor clinical progress and treatment adherence; usual medical care for chronic diseases; and access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles. Study therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. |
| Enhanced Usual Treatment | Active comparator | Behavioral: Enhanced Usual TreatmentThe patients in the primary care clinics assigned to the comparator will receive the usual treatment for depression and their physical conditions -all the guaranteed interventions for people with depression, hypertension, and/or diabetes in primary care, according to the Clinical Guidelines for the Treatment of Depression- and their associated basket of health benefits included in the Regime of Explicit Health Care Guarantees. They will have access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older.
- Enrolled in the Cardiovascular Health Program (i.e. currently receiving treatment for diabetes and/or hypertension) at the study primary care clinics.
- Patient Health Questionnaire-9 Item (PHQ-9) score ≥ 15.
- Signed informed consent.
Key exclusion criteria (7 listed)
- Functional illiteracy (i.e., patients unable to read and comprehend written information, such as the study questionnaires or written informed consent).
- Significant visual and/or auditive impairments (i.e., such as those imposing a serious difficulty to respond the study questionnaires or written informed consent).
- Pregnancy or breastfeeding.
- Cognitive impairment - ineligible patients would give a negative answer to questions "What year is it?" and "Where are we (place/address)?".
- In treatment for bipolar and/or psychotic disorder.
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 |
|---|---|---|
| "Me cuido y me siento mejor"A multicomponent, collaborative, computer-assisted, psycho-educational intervention for the management of depressive symptoms in primary care patients with diabetes and/or hypertension. | Behavioural | "Me cuido y me siento mejor" |
| Enhanced Usual TreatmentEnhanced Usual Treatment | Behavioural | Enhanced Usual Treatment |
Primary outcome
Depression change
Time frame: Even though the primary outcome is taken at six-month follow-up, this measure will also be reported at three- and twelve-month follow-up.
Defined as a 50% reduction in a participant's Patient Health Questionnaire-9 Item (PHQ-9) score compared to the baseline. The PHQ-9 minimum and maximum values are 0 and 27 points. Higher scores mean worse outcomes.
6 secondary outcomes
Proportion of patients who change their depressive status
Time frame: Three-, six-, and twelve-month follow-up.
Health-related quality of life
Time frame: Three-, six-, and twelve-month follow-up.
Social solving problem skills
Time frame: Three-, six-, and twelve-month follow-up.
Proportion of participants with change in blood pressure
Time frame: Three-, six-, and twelve-month follow-up.
Ad-hoc questionnaire for the assessment of the acceptability of depression treatment
Time frame: Three-, six-, and twelve-month follow-up.
Proportion of participants with change in glycosylated hemoglobin
Time frame: Three-, six-, and twelve-month follow-up.
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 6 Dec 2023.
- Derived from this study: PubMed 34419010Rojas G, Martinez P, Guajardo V, Campos S, Herrera P, Vohringer PA, Gomez V, Szabo W, Araya R. A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial. BMC Psychiatry. 2021 Aug 21;21(1):418. doi: 10.1186/s12888-021-03380-2.
- Individual participant dataSharing planned: No
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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.
Graciela Rojas principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Me cuido y me siento mejor" and Enhanced Usual Treatment in people with Depression, run by University of Chile at 1 site 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 4 inclusion and 7 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Depression change (time frame: Even though the primary outcome is taken at six-month follow-up, this measure will also be reported at three- and twelve-month follow-up.). 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 NCT04613076, 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 6 Dec 2023.