Evaluation of the Bounce Back Program
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|ClinicalTrials.gov Identifier: NCT01324648|
Recruitment Status : Unknown
Verified September 2014 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : March 29, 2011
Last Update Posted : September 10, 2014
Lifetime prevalence rates of Major Depressive Disorder (MDD) in Canada are between 10-12% with approximately 1.5 million Canadians reporting depression in any given year. Alarmingly, the burden of ill health associated with MDD is projected to increase worldwide such that by the year 2020, depression will move from its current position of fourth to become the second greatest burden of ill health, closely following ischaemic heart disease (Murray & Lopez, 1998). As depressed patients are often in frequent contact with their primary care physicians for other health problems, effective depression treatment and management currently relies heavily on the primary care sector. Cognitive behavioural therapy (CBT) is an empirically supported psychotherapy that is recommended by the Canadian Network for Mood and Anxiety Treatments Clinical Guidelines as a first-line treatment for depression. However, across Canada, CBT is not readily accessible by primary care physicians for their patients, particularly in rural areas.
To help address this nationwide need for CBT, British Columbia (BC) is the first and only province in Canada to develop and implement a high capacity mental health service, Bounce Back: Reclaim your Health (BB), for primary care patients with mild to moderate depression. In BB, the patients' use of Cognitive-Behavioural Therapy (CBT) self-help materials is supported via trained telephone coaches.
The primary objective of our proposed research is to provide direct evidence of the effectiveness of the BB program, and, in particular, the telephone coaching component. The investigators will test: (1) whether the BB program is more effective than general practitioner (GP) treatment-as-usual (TAU); and (2) whether BB's positive results can be attributed to the telephone coaching component, as this component is associated with the most significant costs of the program. A secondary objective is to assess the cost-effectiveness of such telephone support.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Telephone-supported self-help and GP treatment as usual Behavioral: Unsupported self-help and GP treatment as usual Other: General practitioner treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Trial Evaluation of Brief, Telephone Supported CBT Self-help in Primary Care Patients With Mild to Moderate Depression|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|Experimental: TG + GP TAU||
Behavioral: Telephone-supported self-help and GP treatment as usual
Participants' use of the BB self-help materials will be supported by three to five telephone coaching sessions that occur approximately every 2-3 weeks. Total contact time will be approximately 2 hours (2 hour total contact time will be considered "brief" in our study). Participants will also continue to receive whatever current treatment their general practitioner is providing.
|Experimental: UG + GP TAU||
Behavioral: Unsupported self-help and GP treatment as usual
This treatment was chosen as a control for the telephone coaching component of the BB program. Participants will be sent a package containing the BB self-help materials and along with instructions on how to utilize these materials. Participants will use the materials on their own and at their own pace. Participants will also continue to receive whatever current treatment their general practitioner is providing.
|Active Comparator: GP TAU||
Other: General practitioner treatment as usual
This group will receive treatment as usual - whereby the clinic staff will inform the participant's GP of their PHQ-9 score. They will also be informed that their GP will be contacted that they are taking part in the research and that their GP will continue to support them with their depression as usual.
- Changes in levels of depressive symptomatology [ Time Frame: The PHQ-9 will be assessed at screening, 2 month, 4 month, and 12 month time points. ]Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)
- Changes of levels of anxiety [ Time Frame: The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Levels of anxiety will be measured over tiem, using the Generalized Anxiety Disorder 7 (GAD-7).
- Changes in quality of life and enjoyment [ Time Frame: The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Quality of life and enjoyment will be measured over time using the Quality of Life and Enjoyment Satisfaction Questionnaire (QLES-Q-SF).
- Changes in work and social adjustment [ Time Frame: The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Work and social adjustemnt will be assessed over time, using the Work and Social Adjustment Scale (WASA).
- Changes in work functionality and impairment [ Time Frame: The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Work functionality and impairment will be assessed over time using the Lam Employment and Productivity Scale (LEAPS).
- Changes in mental health literacy [ Time Frame: The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Mental health literacy will be measured over time using the Mental Health Literacy questionnaire (MHL-Q).
- Changes in use of health services [ Time Frame: The CSRI will be asssessed at screening, 4 month, and 12 month time points ]Participants' use of health services will be assessed using the Client Service Receipt Inventory - modified (CSRI).
- Changes in health status [ Time Frame: The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Health status will be assessed using the Euroquol-5 (EQ-5D).
- Changes in health status and health related quality of life [ Time Frame: The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points ]Health status and health related quality of life will be assessed over time using the Health Utilities Index (HUI-3).
- Changes in illness severity [ Time Frame: The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points ]Illness severity will be assessed over time using the Duke Severity of Illness Checklist (DUSOI).
- Client satisfaction. [ Time Frame: The CSQ-9 will be assessed at 4 month time point. ]Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324648
|Contact: Mark Lau, PhDfirstname.lastname@example.org|
|Calgary Foothills Primary Care Network||Recruiting|
|Calgary, Alberta, Canada, T3G0B4|
|Contact: Lorraine Bucholtz 403-284-3726 Lorraine.Bucholtz@cfpcn.ca|
|Contact: Richard Ward, MD email@example.com|
|Sub-Investigator: Richard Ward, MD|
|Chinook Primary Care Network||Recruiting|
|Chinook Valley, Alberta, Canada, T1J013|
|Contact: Lisa Cook, PhD firstname.lastname@example.org|
|Contact: Robert Wedel, MD email@example.com|
|Principal Investigator: Robert Wedel, MD|
|Canada, British Columbia|
|University of British Columbia||Not yet recruiting|
|Vancouver, British Columbia, Canada, V6T2A1|
|Principal Investigator: Mark Lau, PhD|
|Principal Investigator:||Mark Lau, PhD||University of British Columbia|