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Comparison Study of Family Practice Interventions for Depression in Adults

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment as usual
Internet Intervention
Depression Treatment Pathway
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults aged 18 and above
  • Cognitively capable of independently understanding and confirming their desire to take part

Exclusion Criteria:

  • 18 and under
  • Cognitively incapable of independently understanding and confirming their desire to take part

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Arm Description

    Patients will have information collected on their quality of life (QOL) at baseline (EuroQual 5-item measure - "EQ-5D"). Patients will be followed up at week 12 for a repeated measure of QOL and a score on the depression rating scale being used in this study (Patient Health Questionnaire-9 item version - "PHQ-9"). Individuals will also be asked on their health care access frequency (HCAF) at baseline and follow up.

    Group #2. Screening for depression followed by treatment as usual: Patients will complete baseline measurements of their score on the PHQ-9, self-reported HCAF and QOL (EQ-5D) score. The PHQ-9 score will be given to the clinic staff who will then follow up with treatment as usual. Patients will be followed up at week 12 for self-reported HCAF,PHQ-9 and QOL scores.

    Group #3 is Internet intervention: At baseline patients will complete QOL (EQ-5D), PHQ-9 scores, and self-reported HCAF. Those who score 10 or more on the PHQ-9 will be offered a guided internet-based intervention for the treatment of depression by the study staff. Patients will be followed up at week 12 for self-reported HCAF, PHQ-9 and QOL scores.

    Depression Treatment Pathway: At baseline patients will complete PHQ-9, QOL (EQ-5D) scores, and self-reported HCAF. Those who score 10 or more on the PHQ-9 will be offered the specific treatment as determined by the Depression Pathway by the clinic physician. Whenever possible, this pathway will be integrated into the local clinic's electronic medical record system, for ease of administration by the clinic. Patients will be followed up at week 12 for self-reported HCAF, PHQ-9 and QOL (EQ-5D) scores.

    Outcomes

    Primary Outcome Measures

    Reduction in depression scores in those patients who have one of the two treatment interventions
    We expect a reduction in depression scores in those patients who have one of the two treatment interventions (Groups #3 and #4) over a 12-week period, compared to those who are screened for depression, but only receive treatment as usual (Group #2).

    Secondary Outcome Measures

    Reduction in total health care costs
    We expect a reduction in total health care costs in the two treatment groups compared both to those who are not screened for depression (Group #1) and those who are screened for depression, but only receive treatment as usual (Group #2). This will be a within-subject comparison for total health care costs in the 12-weeks prior to the index visit compared to the total health care costs in the 12-weeks following the index visit. Mid-term costs will also be compared between groups for the 12-month period following the index visit. Examples of costs included are the number of doctors visits, any ambulance rides or emergency room visits and lab tests. The data collected will not include any diagnosis or results and will only be used for economic analysis. This data will be owned by the University of Alberta, will not be saved in medical records and no one but the study staff will have access to the data unless authorized by a governement agency or ethics board.

    Full Information

    First Posted
    October 29, 2013
    Last Updated
    July 28, 2020
    Sponsor
    AHS Cancer Control Alberta
    Collaborators
    Addiction & Mental Health Strategic Clinical Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01975207
    Brief Title
    Comparison Study of Family Practice Interventions for Depression in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    May 5, 2015 (Actual)
    Study Completion Date
    May 5, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AHS Cancer Control Alberta
    Collaborators
    Addiction & Mental Health Strategic Clinical Network

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine if treatment of significant depressive symptoms identified in individuals attending a family practice improves either psychiatric outcome, overall health care costs, or Quality of Life (QOL). Two previously developed treatment approaches - an internet-based approach and a comprehensive depression pathway - will be compared to two control groups (those who have treatment as usual after screening for depression and measurement of QOL, and a second control group who will have QOL data only collected). The investigators hope to help Alberta Health Services identify which approach is best as rapidly as possible so that the best approach can be implemented throughout the province of Alberta.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1489 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    No Intervention
    Arm Description
    Patients will have information collected on their quality of life (QOL) at baseline (EuroQual 5-item measure - "EQ-5D"). Patients will be followed up at week 12 for a repeated measure of QOL and a score on the depression rating scale being used in this study (Patient Health Questionnaire-9 item version - "PHQ-9"). Individuals will also be asked on their health care access frequency (HCAF) at baseline and follow up.
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    Group #2. Screening for depression followed by treatment as usual: Patients will complete baseline measurements of their score on the PHQ-9, self-reported HCAF and QOL (EQ-5D) score. The PHQ-9 score will be given to the clinic staff who will then follow up with treatment as usual. Patients will be followed up at week 12 for self-reported HCAF,PHQ-9 and QOL scores.
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    Group #3 is Internet intervention: At baseline patients will complete QOL (EQ-5D), PHQ-9 scores, and self-reported HCAF. Those who score 10 or more on the PHQ-9 will be offered a guided internet-based intervention for the treatment of depression by the study staff. Patients will be followed up at week 12 for self-reported HCAF, PHQ-9 and QOL scores.
    Arm Title
    Group 4
    Arm Type
    Experimental
    Arm Description
    Depression Treatment Pathway: At baseline patients will complete PHQ-9, QOL (EQ-5D) scores, and self-reported HCAF. Those who score 10 or more on the PHQ-9 will be offered the specific treatment as determined by the Depression Pathway by the clinic physician. Whenever possible, this pathway will be integrated into the local clinic's electronic medical record system, for ease of administration by the clinic. Patients will be followed up at week 12 for self-reported HCAF, PHQ-9 and QOL (EQ-5D) scores.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual
    Intervention Description
    Participants will be treated as per clinic's standard treatment for depression.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet Intervention
    Other Intervention Name(s)
    Guided internet-based invtervention, Moodgym, On-line CBT
    Intervention Description
    One of the major treatments for mild-moderate depressive disorders is cognitive behavioural therapy (CBT). It has been possible to operationalize some of this treatment and internet-based approaches to this have been developed. The most widely examined was developed in Australia and is termed "MoodGYM" (https://moodgym.anu.edu.au/welcome). This program has been widely studied, and these studies have shown it is very effective for many individuals in family practice
    Intervention Type
    Behavioral
    Intervention Name(s)
    Depression Treatment Pathway
    Intervention Description
    There has been a growing awareness in health care circles that certain high frequency, high cost addiction and mental health disorders may be best addressed via the systemic adoption of clinical pathways. A clinical pathway is defined as "a multidisciplinary outline of anticipated care, placed in an appropriate timeframe, to help a patient with a specific condition or set of symptoms move progressively through a clinical experience to positive outcomes." A clinical pathway incorporates guidelines, protocols and evidence informed best practice into everyday use for the patient and family.
    Primary Outcome Measure Information:
    Title
    Reduction in depression scores in those patients who have one of the two treatment interventions
    Description
    We expect a reduction in depression scores in those patients who have one of the two treatment interventions (Groups #3 and #4) over a 12-week period, compared to those who are screened for depression, but only receive treatment as usual (Group #2).
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Reduction in total health care costs
    Description
    We expect a reduction in total health care costs in the two treatment groups compared both to those who are not screened for depression (Group #1) and those who are screened for depression, but only receive treatment as usual (Group #2). This will be a within-subject comparison for total health care costs in the 12-weeks prior to the index visit compared to the total health care costs in the 12-weeks following the index visit. Mid-term costs will also be compared between groups for the 12-month period following the index visit. Examples of costs included are the number of doctors visits, any ambulance rides or emergency room visits and lab tests. The data collected will not include any diagnosis or results and will only be used for economic analysis. This data will be owned by the University of Alberta, will not be saved in medical records and no one but the study staff will have access to the data unless authorized by a governement agency or ethics board.
    Time Frame
    12 weeks/12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults aged 18 and above Cognitively capable of independently understanding and confirming their desire to take part Exclusion Criteria: 18 and under Cognitively incapable of independently understanding and confirming their desire to take part
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter H Silverstone, M.D.
    Organizational Affiliation
    Alberta Health Services and University of Alberta
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Katherine Rittenbach, PhD
    Organizational Affiliation
    Alberta Health services
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20528705
    Citation
    Hickie IB, Davenport TA, Luscombe GM, Moore M, Griffiths KM, Christensen H. Practitioner-supported delivery of internet-based cognitive behaviour therapy: evaluation of the feasibility of conducting a cluster randomised trial. Med J Aust. 2010 Jun 7;192(S11):S31-5. doi: 10.5694/j.1326-5377.2010.tb03690.x.
    Results Reference
    background
    PubMed Identifier
    31382932
    Citation
    Yan C, Rittenbach K, Souri S, Silverstone PH. Cost-effectiveness analysis of a randomized study of depression treatment options in primary care suggests stepped-care treatment may have economic benefits. BMC Psychiatry. 2019 Aug 5;19(1):240. doi: 10.1186/s12888-019-2223-3.
    Results Reference
    derived

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    Comparison Study of Family Practice Interventions for Depression in Adults

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