DepressionPARTNERsNCT02345122
CAMH PARTNERs Integrated Care Study
A study testing Intervention: Mental Health Technician in people with Depression and Anxiety, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This research study will evaluate an integrated care model of telephone-based, computer-aided care management using a new role of Mental Health Technician and specialized software to support primary care providers in providing mental health care. The study will compare the effectiveness of this model vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Alcohol Drinking
- What is being tested?
- Intervention: Mental Health Technician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 and older
- Receiving care from a Primary Care Provider at one of the participating health care organizations
- Self-referred or referred by a participating primary care provider because of suspected depression, anxiety, alcohol disorder or at risk drinking
- Having access to a telephone
- Willingness and ability to converse in English by telephone
- Corrected auditory acuity that enables to converse in English by telephone
- Willingness and ability to provide informed consent
Who cannot join
- Not meeting all inclusion criteria
- Lifetime primary psychotic illness, bipolar disorder, obsessive-compulsive disorder, or post-traumatic disorder
- Current substance abuse or dependence (not including alcohol use disorders)
- Clinically significant cognitive impairment as indicated by a score of 16 or above on the Blessed Orientation Memory Concentration Test
- High risk for suicide as indicated by the 5-item Paykel Scale
- Being physically unstable as evidenced by needing to be hospitalized
- Being expected by one's Primary Care Provider to die during the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAMH PARTNERs: Integrated Care for Better Outcomes
This research study will evaluate an integrated care model of telephone-based, computer-aided care management using a new role of Mental Health Technician and specialized software to support primary care providers in providing mental health care. The study will compare the effectiveness of this model vs. enhanced usual care in improving initiation of specific treatment by the primary care provider, reduction in severity of symptoms, and improvement in quality of life or functioning.
Read the detailed description
This is a randomized clinical trial of an intervention to improve the outcomes of depressive disorders, generalized anxiety, panic disorder, and at-risk drinking or alcohol use disorders in primary care. Two groups will be included: (1) Adult patients who self-refer or are referred to the study by their Primary Care Provider; or (2) patients who are referred by their Primary Care Provider to the tele-mental health consultation service at the Centre for Addiction and Mental Health (Toronto, Ontario). Patients who consent and meet the eligibility criteria will be randomized to either: (1) usual care provided by their Primary Care Provider enhanced by a baseline assessment and follow-up assessments 4, 8, and 12 months later; or (2) an intervention consisting of care provided by their Primary Care Provider enhanced by a baseline assessment, follow-up assessments 4, 8, and 12 months later plus psychoeducation, monitoring, and support offered by telephone by a Mental Health Technician receiving supervision from a project psychiatrist.
At baseline and 4, 8, and 12 months later, symptoms, quality of life, and function of all participants will be assessed by telephone by Research Analysts (RAs) blind to the randomization. In addition, at 12 months, patient satisfaction will be assessed. Results of these assessments will be shared with the participant's Primary Care Provider, regardless of randomization. The Primary Care Provider will receive a document summarizing the results of the baseline assessment and the three follow-up assessments for the participants of both the usual care and intervention groups. For participants in the intervention group the Primary Care Provider will also receive treatment recommendations and updates as needed.
In the enhanced usual care group, the Primary Care Provider will treat the participant as they deem appropriate. In the intervention group, participants will be assigned to a team constituted by a Mental Health Technician and a psychiatrist. The team will communicate evidence-based treatment recommendations to the Primary Care Provider, for example initiating the use of an antidepressant or referring the participant for therapy or counselling. The Mental Health Technician will offer participants telephone-based psychoeducation about their diagnoses made by their Primary Care Provider or other consulting physicians, their symptoms, and the treatment selected by the Primary Care Provider. The Mental Health Technician will also monitor by phone the progress of treatment and communicate updates to the Primary Care Provider with additional recommendations as required. Thus, the Mental Health Technician will contact the Primary Care Provider on an as needed basis. In addition, for participants who are doing well and for whom no new recommendations are needed, the Mental Health Technician will provide a brief "progress report" to the Primary Care Provider on a monthly basis.
In addition, at the completion of the one-year period, the RA will review all the participants' charts to abstract the intervention (e.g., medications, doses, refills) and other health services (e.g., diagnostic tests, referrals, mental health evaluations) they have received during their participation in the study. The chart audit will be conducted using REDCap, a secure application supported by the CAMH Information Management Group (IMG). IMG has all the necessary physical and operational securities in place to meet security and privacy regulations for data transmission and storage using REDCap. Investigators will follow the best practices outlined by IMG to ensure that all data and information is kept private and confidential.
- Conditions
- Depression, Anxiety, Alcohol Drinking
- Being tested
- Intervention: Mental Health Technician, Enhanced Usual Care
- Keywords
- At-risk Drinking, Depression, Anxiety, Alcohol Drinking
- Medical subject headings
- Depression, Anxiety Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Mental Health TechnicianBehavioural
In addition to structured assessments at baseline, four, eight and twelve months (the results will be shared with their Primary Care Provider), subjects will receive psychoeducation regarding their depression, anxiety, and alcohol use disorder or at-risk drinking; symptom monitoring; and medication adherence support. Their Primary Care Provider will also be provided evidence-based recommendations regarding their treatment.
Enhanced Usual CareOther
Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve months. The results will be shared with their Primary Care Provider.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Other | This group will receive Enhanced Usual Care. The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life . If the subjects primary care provider chooses, they can use this information to construct the subject's treatment plan. Receives: Other: Enhanced Usual Care |
| Intervention: Mental Health Technician | Experimental | The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life and recommendations for treatment. Over a 3-12 months period, the Intervention group will receive a brief, telephone-based intervention by a Mental Health Technician that will focus on monitoring symptoms, treatment adherence, and providing psychoeducation. Receives: Behavioral: Intervention: Mental Health Technician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depressive symptoms, as measured with PHQ-9 during phone interviews at 4, 8, and 12 months
Mixed models will be used to assess changes in depressive symptoms among depressed participants (i.e., those with a PHQ-9 score of 10 or higher at baseline) adjusting for relevant covariates and clustering within subjects over time and within sites. Change in PHQ-9 scores (follow-up minus baseline scores) will be compared between treatment groups with a linear contrast model including the main effects of time, treatment group, and their interaction with the expectation to detect a group effect and a group x time interaction. Time will have 4 levels (Baseline, 4, 8 and 12 months); treatment group will have two levels (EUC and Intervention). We will test the bivariate association between baseline socio-demographics and baseline PHQ-9 scores with treatment group. Variables associated at a significance level of 0.05, will be entered in the model as covariates. Comorbidities will be also entered as control variables.
Measured: One year
Secondary outcomes (3)
Initiation or change in antidepressant medication documented in the health record at the 4-, 8-, and 12-month follow up
Generalized Estimating Equation (GEE) will be used to compare the proportion of subjects that started the treatment for each specific comorbidity in the first 12 months after start of the study. The model will use logit link and consider sites and PCPs as clustering structures, and besides the simple test of study group effect the model will also control for relevant covariates detected in the initial descriptive group comparison (see Primary Outcome). Time will also enter the model as a categorical predictor with 4 levels. Separate models will be fitted for each condition (depression, anxiety, and alcohol use disorder) and each model will control for the existence or not of the other two conditions. The outcome variable for each analysis will be a simple binary indicator of whether the treatment started or not during the interval analyzed.
Measured: One year
Severity of anxiety symptoms during the past 2 weeks and number of drinks during the past week
Participants will be interviewed over the phone with the Generalized Anxiety Disorder-7 (GAD-7) and the Alcohol Use 7 Day Timeline Followback at baseline, 4, 8, and 12 months. Mixed models will be used to assess changes in anxiety symptoms among anxious participants (i.e., those with a GAD-7 score of 10 or higher at baseline) or changes in the number of drinks during the past week among those with at-risk drinking (defined as drinking 10 or more drinks per week for a female, 15 or more drinks per week for a male, or having 4 or more binges during the past 3 months - with a binge defined as 4 or more drinks in a single day for a female and 5 or more drinks in a single day for a male). Mixed models adjust for all relevant covariates and clustering within subjects over time, within sites, and within Primary Care Providers. These changes will be defined and analyzed as the changes in PHQ-9 scores described above.
Measured: One year
Time to initiation of first specific treatment for depression by the primary care provider
Time to initiation of first treatment will be tested using Cox regression, and logistic regression analysis will be used to determine whether the proportion of cases receiving treatment differs across study arms after controlling for all relevant covariates
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- CAMH Foundation, Capital Solution Design LLC
- Responsible party
- Principal investigator, Benoit Mulsant, Centre for Addiction and Mental Health
- Investigators
- Benoit H Mulsant, MD, Principal investigator, Centre for Addition and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345122
- Sponsor's protocol ID
- 054/2014
- Acronym
- PARTNERs
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2015
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rodie DJ, Fitzgibbon K, Perivolaris A, Crawford A, Geist R, Levinson A, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. The primary care assessment and research of a telephone intervention for neuropsychiatric conditions with education and resources study: Design, rationale, and sample of the PARTNERs randomized controlled trial. Contemp Clin Trials. 2021 Apr;103:106284. doi: 10.1016/j.cct.2021.106284. Epub 2021 Jan 19.
PubMed 33476774Zaheer S, Garofalo V, Rodie D, Perivolaris A, Chum J, Crawford A, Geist R, Levinson A, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. Computer-Aided Telephone Support for Primary Care Patients with Common Mental Health Conditions: Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 10;5(4):e10224. doi: 10.2196/10224.
PubMed 30530461
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMH PARTNERs: Integrated Care for Better Outcomes
- ClinicalTrials.gov ID
- NCT02345122
- Acronym / sponsor ID
- PARTNERs / 054/2014
- Conditions
- Depression, Anxiety, Alcohol Drinking
- Keywords
- At-risk Drinking, Depression, Anxiety, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- CAMH Foundation, Capital Solution Design LLC
- Study start
- Nov 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 2015 (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.
This research study will evaluate an integrated care model of telephone-based, computer-aided care management using a new role of Mental Health Technician and specialized software to support primary care providers in providing mental health care. The study will compare the effectiveness of this model vs. enhanced usual care in improving initiation of specific treatment by the primary care provider, reduction in severity of symptoms, and improvement in quality of life or functioning.
Detailed description
This is a randomized clinical trial of an intervention to improve the outcomes of depressive disorders, generalized anxiety, panic disorder, and at-risk drinking or alcohol use disorders in primary care. Two groups will be included: (1) Adult patients who self-refer or are referred to the study by their Primary Care Provider; or (2) patients who are referred by their Primary Care Provider to the tele-mental health consultation service at the Centre for Addiction and Mental Health (Toronto, Ontario). Patients who consent and meet the eligibility criteria will be randomized to either: (1) usual care provided by their Primary Care Provider enhanced by a baseline assessment and follow-up assessments 4, 8, and 12 months later; or (2) an intervention consisting of care provided by their Primary Care Provider enhanced by a baseline assessment, follow-up assessments 4, 8, and 12 months later plus psychoeducation, monitoring, and support offered by telephone by a Mental Health Technician receiving supervision from a project psychiatrist.
At baseline and 4, 8, and 12 months later, symptoms, quality of life, and function of all participants will be assessed by telephone by Research Analysts (RAs) blind to the randomization. In addition, at 12 months, patient satisfaction will be assessed. Results of these assessments will be shared with the participant's Primary Care Provider, regardless of randomization. The Primary Care Provider will receive a document summarizing the results of the baseline assessment and the three follow-up assessments for the participants of both the usual care and intervention groups. For participants in the intervention group the Primary Care Provider will also receive treatment recommendations and updates as needed.
In the enhanced usual care group, the Primary Care Provider will treat the participant as they deem appropriate. In the intervention group, participants will be assigned to a team constituted by a Mental Health Technician and a psychiatrist. The team will communicate evidence-based treatment recommendations to the Primary Care Provider, for example initiating the use of an antidepressant or referring the participant for therapy or counselling. The Mental Health Technician will offer participants telephone-based psychoeducation about their diagnoses made by their Primary Care Provider or other consulting physicians, their symptoms, and the treatment selected by the Primary Care Provider. The Mental Health Technician will also monitor by phone the progress of treatment and communicate updates to the Primary Care Provider with additional recommendations as required. Thus, the Mental Health Technician will contact the Primary Care Provider on an as needed basis. In addition, for participants who are doing well and for whom no new recommendations are needed, the Mental Health Technician will provide a brief "progress report" to the Primary Care Provider on a monthly basis.
In addition, at the completion of the one-year period, the RA will review all the participants' charts to abstract the intervention (e.g., medications, doses, refills) and other health services (e.g., diagnostic tests, referrals, mental health evaluations) they have received during their participation in the study. The chart audit will be conducted using REDCap, a secure application supported by the CAMH Information Management Group (IMG). IMG has all the necessary physical and operational securities in place to meet security and privacy regulations for data transmission and storage using REDCap. Investigators will follow the best practices outlined by IMG to ensure that all data and information is kept private and confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Other | Other: Enhanced Usual CareThis group will receive Enhanced Usual Care. The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life . If the subjects primary care provider chooses, they can use this information to construct the subject's treatment plan. |
| Intervention: Mental Health Technician | Experimental | Behavioral: Intervention: Mental Health TechnicianThe subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life and recommendations for treatment. Over a 3-12 months period, the Intervention group will receive a brief, telephone-based intervention by a Mental Health Technician that will focus on monitoring symptoms, treatment adherence, and providing psychoeducation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 and older
- Receiving care from a Primary Care Provider at one of the participating health care organizations
- Self-referred or referred by a participating primary care provider because of suspected depression, anxiety, alcohol disorder or at risk drinking
- Having access to a telephone
- Willingness and ability to converse in English by telephone
Key exclusion criteria (7 listed)
- Not meeting all inclusion criteria
- Lifetime primary psychotic illness, bipolar disorder, obsessive-compulsive disorder, or post-traumatic disorder
- Current substance abuse or dependence (not including alcohol use disorders)
- Clinically significant cognitive impairment as indicated by a score of 16 or above on the Blessed Orientation Memory Concentration Test
- High risk for suicide as indicated by the 5-item Paykel Scale
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 |
|---|---|---|
| Intervention: Mental Health TechnicianIn addition to structured assessments at baseline, four, eight and twelve months (the results will be shared with their Primary Care Provider), subjects will receive psychoeducation regarding their depression, anxiety, and alcohol use disorder or at-risk drinking; symptom monitoring; and medication adherence support. Their Primary Care Provider will also be provided evidence-based recommendations regarding their treatment. | Behavioural | Intervention: Mental Health Technician |
| Enhanced Usual CareSubjects will receive structured, quantitative assessments at baseline, four, eight and twelve months. The results will be shared with their Primary Care Provider. | Other | Enhanced Usual Care |
Primary outcome
Severity of depressive symptoms, as measured with PHQ-9 during phone interviews at 4, 8, and 12 months
Time frame: One year
Mixed models will be used to assess changes in depressive symptoms among depressed participants (i.e., those with a PHQ-9 score of 10 or higher at baseline) adjusting for relevant covariates and clustering within subjects over time and within sites. Change in PHQ-9 scores (follow-up minus baseline scores) will be compared between treatment groups with a linear contrast model including the main effects of time, treatment group, and their interaction with the expectation to detect a group effect and a group x time interaction. Time will have 4 levels (Baseline, 4, 8 and 12 months); treatment group will have two levels (EUC and Intervention). We will test the bivariate association between baseline socio-demographics and baseline PHQ-9 scores with treatment group. Variables associated at a significance level of 0.05, will be entered in the model as covariates. Comorbidities will be also entered as control variables.
3 secondary outcomes
Initiation or change in antidepressant medication documented in the health record at the 4-, 8-, and 12-month follow up
Time frame: One year
Severity of anxiety symptoms during the past 2 weeks and number of drinks during the past week
Time frame: One year
Time to initiation of first specific treatment for depression by the primary care provider
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 33476774Rodie DJ, Fitzgibbon K, Perivolaris A, Crawford A, Geist R, Levinson A, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. The primary care assessment and research of a telephone intervention for neuropsychiatric conditions with education and resources study: Design, rationale, and sample of the PARTNERs randomized controlled trial. Contemp Clin Trials. 2021 Apr;103:106284. doi: 10.1016/j.cct.2021.106284. Epub 2021 Jan 19.
- Derived from this study: PubMed 30530461Zaheer S, Garofalo V, Rodie D, Perivolaris A, Chum J, Crawford A, Geist R, Levinson A, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. Computer-Aided Telephone Support for Primary Care Patients with Common Mental Health Conditions: Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 10;5(4):e10224. doi: 10.2196/10224.
- The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.Link provided by the sponsor.
- 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.
Benoit H Mulsant, MD principal investigator
Centre for Addition and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Mental Health Technician in people with Depression and Anxiety, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Severity of depressive symptoms, as measured with PHQ-9 during phone interviews at 4, 8, and 12 months (time frame: One year). 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 NCT02345122, which also lists 2 linked publications.
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 13 Apr 2026.