CAMH PARTNERs Integrated Care Study

NCT02345122 | Active Not Recruiting

• 1 other identifier: 054/2014
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Anxiety; Alcohol Drinking

Keywords

At-risk Drinking; Depression; Anxiety; Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  One year

• Severity of anxiety symptoms during the past 2 weeks and number of drinks during the past week

  One year

• Time to initiation of first specific treatment for depression by the primary care provider

  One year

Other Outcomes (3)

• Proportion of subjects receiving treatment for depression, anxiety, an alcohol use disorder or at-risk drinking

  One year

• Rates of depression remission, depression response, anxiety remission, anxiety response, and decrease in alcohol use to the point where it meets the guidelines for safe drinking, remaining stable, or worsening.

  One year

• Changes on the Veterans Rand-12 (VR-12) Health Survey

  One year

Study Arms (2)

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.

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.

Behavioral: Intervention: Mental Health Technician

Interventions

Intervention: Mental Health Technician BEHAVIORAL

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.

Intervention: Mental Health Technician

Enhanced Usual Care OTHER

Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve months. The results will be shared with their Primary Care Provider.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• CAMH Foundation: collaborator
• Capital Solution Design LLC: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 33476774 DERIVED

• Zaheer 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.

  PMID: 30530461 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Depression; Anxiety Disorders; Alcohol Drinking

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Drinking Behavior

Study Officials

• Benoit H Mulsant, MD

  Centre for Addition and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)