Effectiveness of a Self-care Intervention for Depression in Primary Care Patients With Chronic Physical Illnesses (DIRECT-sc)
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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) |
- Patient Health Questionnaire (PHQ-9) depression severity measure [ Time Frame: Screening, 6 months ] [ Designated as safety issue: No ]9 item depression severity scale (self-report)
- 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
- Leisure-time exercise frequency and duration [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]8 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 ]8 item Client Satisfaction Questionnaire (CSQ)
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (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 |
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| Contact: Jane McCusker, MD DrPH | 514 345 3511 ext 5060 | jane.mccusker@mcgill.ca |
| Canada, Quebec | |
| St. Mary's Research Centre | Recruiting |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Principal Investigator: Jane McCusker, Md DrPH | |
| 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: | March 15, 2012 |
| 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:
|
Chronic Disease Depression Depressive Disorder Disease Attributes |
Pathologic Processes Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013