Effectiveness of a Self-care Intervention for Depression in Primary Care Patients With Chronic Physical Illnesses (DIRECT-sc)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Jane McCusker, MD DrPH, McGill University
ClinicalTrials.gov Identifier:
NCT01521013
First received: January 23, 2012
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

When patients present with both a chronic disease and depression, family physicians agree that treatment and follow-up is more complicated and that patients' health suffers as a result. Programs to help depressed patients learn skills to help manage their mood have been developed (depression self-care), using workbooks and audio-visual materials. The programs show promise, but little is known about how these self-care programs may work for patients with depression and chronic disease.

Researchers are proposing a study to evaluate a depression self-care programme for patients age 40 and over who have at least mild depressive symptoms as well as a chronic physical illness and who are treated primarily by a family physician. All study participants (250 patients selected from different family medicine clinics in Montreal) will receive a package of depression self-care materials which include the Antidepressant Skills Workbook, developed in Canada, available in French and English, and used in several provinces in depression self-management programs; a video on depression; a mood monitoring tool; an information booklet to give to family members; and information on additional resources (books, internet materials, and local community groups). The participants will be assigned to one of two groups randomly (like a coin toss): one group will receive the materials only, the other group will receive the materials as well as regular telephone support for up to 6 months by a trained coach who will answer any questions the participant may have on the materials they are working with.

All participants who agree to be in the study will be interviewed three times: once at the beginning of the study, then at 3 months and finally at 6 months. Patients' depression scores will be evaluated to determine the effectiveness of the self-care programme with and without the support of the coach. Researchers will also look at the effect that self-care may have on use and costs of health services, and whether engaging in self-care has an impact on health behaviours (like exercise, taking medications correctly and smoking and alcohol consumption).

All study data will be anonymous; any information that could potentially allow identification of a participant will be removed.


Condition Intervention
Depression
Chronic Disease
Behavioral: Supported self-care
Behavioral: Unsupported self-care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Supported Self-Care Intervention for Depression Compared to an Unsupported Intervention in Older Adults With Chronic Physical Illnesses (DIRECT-sc)

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Patient Health Questionnaire (PHQ-9) depression severity measure [ Time Frame: Screening, 3 months, 6 months ] [ Designated as safety issue: No ]
    9 item depression severity scale (self-report)


Secondary Outcome Measures:
  • Health services utilization and costs [ Time Frame: Baseline, 3 months, 6 months and 12 months. ] [ Designated as safety issue: No ]
    Hopsital, emergency department, doctor visits, home care services. 3 and 6 month data by self-report. 12 month data using provincial administrative databases.

  • General health status (SF-12) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    12 item physical and mental health status (self-report)

  • Depression diagnoses [ Time Frame: Screening and 6 months ] [ Designated as safety issue: No ]
    Major and minor depression (from PHQ-9)

  • Changes in depression treatment [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Antidepressant medication and psychotherapy

  • Activation (Using the Patient Activation Measure - PAM) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    13-item scale (self-report) assessing level of patient involvement in care.

  • Self-efficacy for depression self-care [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    4 item, self-report

  • Engagement in social and leisure-time activities [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Engagement in 13 everyday (e.g. social, solitary, productive) activities, during the week before the interview, including: visits with family/friends, groups activities, hobbies, volunteer work… (self-report)

  • Smoking and alcohol consumption [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    current use (self-report)

  • Medication adherence [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    4 item Morisky scale (self-report)

  • Satisfaction with care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    3 item Client Satisfaction Questionnaire (CSQ)

  • Severity of anxiety symptoms (GAD-7) [ Time Frame: Screening, 3 months, 6 months ] [ Designated as safety issue: No ]
    Continuous measure of severity of anxiety symptoms

  • Exercise (International Physical Activity Questionnaire) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Number of group and individual activities as well as walking time from the International Physical Activity Questionnaire

  • Self-care tool use [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    We will measure 1) the number of the 3 core tools used; and 2) use of the CBT-based section of the workbook


Other Outcome Measures:
  • Self-care tool use (mediating variable) [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
    We will measure 1) the number of the 3 core tools used; and 2) use of the CBT-based section of the workbook

  • Activation (using the patient activation measure - PAM) (mediating variable) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    13-item scale (self-report) assessing level of patient involvement in care.

  • Self-efficacy for depression self-care (mediating variable) [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    4 item, self-report

  • Exercise (International Physical Activity Questionnaire)(mediating variable) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Number of group and individual activities as well as walking time from the International Physical Activity Questionnaire

  • Engagement in social and leisure-time activities (mediating variable) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Engagement in 13 everyday (e.g. social, solitary, productive) activities, during the week before the interview, including: visits with family/friends, groups activities, hobbies, volunteer work… (self-report)

  • Smoking and alcohol consumption (mediating variable) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    current use (self-report)

  • Medication adherence (mediating variable) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    4 item Morisky scale (self-report)

  • Sex (modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Male/Female

  • Age (modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    40-54, 55-64, 65+

  • Language of intervention (modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    French/English

  • Education (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    high school not completed, high school only completed, high school and university completed

  • Family income (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Low, other

  • Physical health status (Physical component summary 12 (PCS-12))(modifying variable) [ Time Frame: Baseline 6 months ] [ Designated as safety issue: No ]
    Assesses physical function

  • Depression diagnosis (PHQ-9)(modifying variable) [ Time Frame: Screening and 6 months ] [ Designated as safety issue: No ]
    Major and minor depression (from PHQ-9)

  • Anxiety disorder diagnosis (GAD-7)(modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Probable, possible or no anxiety disorder

  • Alcohol abuse and dependence (CAGE questionnaire)(modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Probable, possible or no alcohol abuse or dependence

  • Cognitive impairment (BOMC) (modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    6 item Blessed Orientation-Memory-Concentration test (BOMC) detects cognitive impairment

  • Level of activation - categorical (PAM) (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Use of PAM as a categorical variable provides 4 distinct levels of activation

  • Level of self-efficacy - categorical (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This scale used categorically provides us with 4 quartiles of self-efficacy

  • Types of primary care clinic (modifying variable) [ Time Frame: Self-referral ] [ Designated as safety issue: No ]
    Solo practice, Family medicine group, network clinic, other

  • Family physician involvement in the study (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Clinics will be described using 4 categories: 1)a Family physician (FP) in a participating clinic, 2)an MD (but not an FP) in participating clinic, 3)an MD or FP working in a clinic that does not participate in the study, 4)patient doesn't have a primary care provider.

  • Family involvement in self-care (Rosland scale) (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Scale capturing both the domain and frequency of support by family members

  • Date of randomization (modifying variable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Used to capture time and coach effects on intervention

  • Time elapsed between screening and randomization (modifying variable) [ Time Frame: Screening, baseline ] [ Designated as safety issue: No ]
    Less than 2 weeks, 2 to 4 weeks, mor than 4 weeks

  • Physical health (presence of multimorbidity) (modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Self-reported presence of chronic disease

  • Physical health (presence of chronic pain) (modifying variable) [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Presence of daily pain lasting for at least 6 months


Estimated Enrollment: 250
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supported self-care Behavioral: Supported self-care

Subjects will receive a package of depression self-care materials, to include the Antidepressant Skills Workbook, a mood monitoring tool, an informational video on depression, information for family members, and information on additional resources (reading materials, internet sites, community groups).

Subjects will be contacted (by telephone) by their coach, initially at weekly intervals. The frequency of calls will thereafter be mutually determined by subject and coach, but will not exceed weekly calls during the first 3 months, or monthly calls from months 3 to 6. Calls will last an average of 10 minutes. The coach will follow a script to educate/ motivate/guide the subject in the use of the Workbook.

Active Comparator: Unsupported self-care Behavioral: Unsupported self-care
Subjects will receive a package of depression self-care materials, to include the Antidepressant Skills Workbook, a mood monitoring tool, an informational video on depression, information for family members, and information on additional resources (reading materials, internet sites, community groups).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 40 or more;
  • with one or more doctor-diagnosed chronic physical illnesses or chronic pain at least 6 months duration;
  • and with persistent depressive symptoms (≥ 1 month)

Exclusion Criteria:

  • PHQ-9 score of less than 5,
  • resident in a nursing home,
  • suicidal,
  • receiving CBT from any health professional,
  • unable to read in either English or French,
  • more than mild cognitive impairment,
  • any other impairment that would prevent them from participating in telephone interviews
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521013

Locations
Canada, Quebec
St. Mary's Research Centre
Montreal, Quebec, Canada, H3T 1M5
Sponsors and Collaborators
McGill University
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Jane McCusker, MD DrPH St. Mary's Research Centre
  More Information

No publications provided

Responsible Party: Jane McCusker, MD DrPH, Principal investigator, principal scientist, McGill University
ClinicalTrials.gov Identifier: NCT01521013     History of Changes
Other Study ID Numbers: MP-CHSM-11-030
Study First Received: January 23, 2012
Last Updated: October 30, 2013
Health Authority: Canada: Fonds de la recherche en santé du Quebec
Canada: Research Ethics Committee (REC) of St. Mary's Hospital Center

Additional relevant MeSH terms:
Depression
Depressive Disorder
Chronic Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014