Evaluation of the Bounce Back Program

NCT ID: NCT01324648

Last Updated: 2014-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TG + GP TAU

Group Type: EXPERIMENTAL

Telephone-supported self-help and GP treatment as usual

Intervention Type: BEHAVIORAL

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.

UG + GP TAU

Group Type: EXPERIMENTAL

Unsupported self-help and GP treatment as usual

Intervention Type: BEHAVIORAL

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.

GP TAU

Group Type: ACTIVE_COMPARATOR

General practitioner treatment as usual

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Mental Health Association

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Lau, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Calgary Foothills Primary Care Network

Calgary, Alberta, Canada

Site Status: RECRUITING

Chinook Primary Care Network

Chinook Valley, Alberta, Canada

Site Status: RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Mark Lau, PhD

Role: CONTACT

mlau4@bcmhs.bc.ca

604-707-6358

Facility Contacts

Lorraine Bucholtz

Role: primary

Lorraine.Bucholtz@cfpcn.ca

403-284-3726

Richard Ward, MD

Role: backup

raward@direct.ca

Lisa Cook, PhD

Role: primary

lisa.cook@albertahealthservices.ca

Robert Wedel, MD

Role: backup

rwedel@telusplanet.net

Related Links

http://www.cmha.bc.ca/bounceback

Related Info

Other Identifiers

106504

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H08-02847

Identifier Type: -

Identifier Source: org_study_id