Evaluation of the Bounce Back Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of British Columbia
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Mental Health Association
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01324648
First received: March 14, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluation of Brief, Telephone Supported CBT Self-help in Primary Care Patients With Mild to Moderate Depression

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)


Secondary Outcome Measures:
  • Changes of levels of anxiety [ Time Frame: The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).


Estimated Enrollment: 213
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

This proposed project is designed to evaluate and provide direct evidence for the clinical effectiveness of the Bounce Back: Reclaim your Health (BB) project currently implemented in 17 communities in British Columbia (BC). BB is an innovative mental health service in the health care system designed to help patients participate in their own care by teaching them the sufficient and necessary skills to manage their moods. This BB program, led by the Canadian Mental Health Association's BC Division, offers mental health support to primary care patients suffering from mild to moderate depression. BB is a low intensity, high capacity program, based on cognitive behaviour therapy (CBT) self-help materials Overcoming Depression, Low Mood and Anxiety: A five areas approach (OD - comprising psycho-educational DVD and self-help mood improvement workbook). The content of these self-help materials was adapted to a BC context for the BB program. In addition, in order to best meet the needs of BC primary care patients, this new mental health service is delivered to patients in their own homes and patients' use of the OD self-help materials is supported via trained telephone coaches. Telephone coaches are non-specialists trained and monitored by a registered psychologist. Coaching enables patients to engage with and get the most out of the materials. The advantages of telephone coaching include privacy, accessibility, and convenience, especially for those patients living in rural areas and can not access treatment due to geographic barriers; those who do not seek treatment due to stigma; or those who are coping with chronic physical illness and multiple medical appointments. There is only indirect support for the effectiveness of the BB program. Thus, this proposed project is designed to evaluate and provide direct evidence of the effectiveness of the BB program.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • currently experiencing a mild to moderate level of depressive symptoms as defined by a score of 5 - 19 on the PHQ-9;
  • 19 years of age or older
  • willing to use the BB program;
  • able to use the BB self-help materials with telephone coaching (have access to read, hear a telephone conversation and have a telephone); and,
  • ability to give informed consent and complete questionnaires unassisted.

Exclusion Criteria:

  • a SCID diagnosis (past or present) of: (a) Bipolar Disorder; (b) Schizophreniform Disorders; (c) Substance Abuse or Dependence (current or within the past six months); (d) Borderline or Antisocial Personality Disorder (based on GP's diagnosis); or (e) Cognitive Disorder (as the BB program is not appropriate for these individuals);
  • active suicidal intent, (as defined by a score of 2 or more on the BDI-II suicide item #9; those with passive suicidal ideation will be monitored;
  • impaired concentration and motivation (scoring 7 or more on the combined BDI-II items #15, 19 and 20 for energy, concentration difficulty and tiredness, respectively);
  • are currently receiving, or have received in the previous 6 months, CBT or guided self-help for depression; or,
  • are involved in other clinical research studies.
  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: NCT01324648

Contacts
Contact: Mark Lau, PhD 604-707-6358 mlau4@bcmhs.bc.ca

Locations
Canada, Alberta
Calgary Foothills Primary Care Network Recruiting
Calgary, Alberta, Canada, T3G0B4
Contact: Lorraine Bucholtz    403-284-3726    Lorraine.Bucholtz@cfpcn.ca   
Contact: Richard Ward, MD       raward@direct.ca   
Sub-Investigator: Richard Ward, MD         
Chinook Primary Care Network Recruiting
Chinook Valley, Alberta, Canada, T1J013
Contact: Lisa Cook, PhD       lisa.cook@albertahealthservices.ca   
Contact: Robert Wedel, MD       rwedel@telusplanet.net   
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         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Canadian Mental Health Association
Investigators
Principal Investigator: Mark Lau, PhD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01324648     History of Changes
Other Study ID Numbers: H08-02847, 106504
Study First Received: March 14, 2011
Last Updated: February 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Guided self-help
Telephone delivery
Cognitive behavior therapy
Bibliotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014