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

NCT01521013 | Completed

• 1 other identifier: MP-CHSM-11-030
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9) depression severity measure

  9 item depression severity scale (self-report)

  Screening, 3 months, 6 months

Secondary Outcomes (13)

• Health services utilization and costs

  Baseline, 3 months, 6 months and 12 months.

• General health status (SF-12)

  Baseline and 6 months

• Depression diagnoses

  Screening and 6 months

• Changes in depression treatment

  Baseline and 6 months

• Activation (Using the Patient Activation Measure - PAM)

  Baseline and 6 months

Other Outcomes (26)

• Self-care tool use (mediating variable)

  3 months, 6 months

• Activation (using the patient activation measure - PAM) (mediating variable)

  Baseline and 6 months

• Self-efficacy for depression self-care (mediating variable)

  Baseline, 3 months, and 6 months

Study Arms (2)

Supported self-care

ACTIVE COMPARATOR

Behavioral: Supported self-care

Unsupported self-care

ACTIVE COMPARATOR

Behavioral: Unsupported self-care

Interventions

Supported self-care BEHAVIORAL

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.

Supported self-care

Unsupported self-care BEHAVIORAL

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).

Unsupported self-care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

St. Mary's Research Centre

Montreal, Quebec, H3T 1M5, Canada

Location

Related Publications (1)

• McCusker J, Cole M, Lambert S, Yaffe M, Ciampi A, Belzile E. Baseline Psychological Treatment Reduces the Effect of Coaching in a Randomised Trial of a Depression Self-Care Intervention. Can J Psychiatry. 2017 Jan;62(1):67-72. doi: 10.1177/0706743716648299. Epub 2016 Jul 9.

  PMID: 27310241 DERIVED

MeSH Terms

Conditions

Depression; Chronic Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane McCusker, MD DrPH

  St. Mary's Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 30, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (1)