Clinical trial NCT01324648: Evaluation of the Bounce Back Program
Official title: A Randomized Controlled Trial Evaluation of Brief, Telephone Supported CBT Self-help in Primary Care Patients With Mild to Moderate Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Guided self-help
Telephone delivery
Cognitive behavior therapy
Bibliotherapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Mental Health Association
First posted: 2011-03-29
Enrollment: 213
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in levels of depressive symptomatology
timeFrame: The PHQ-9 will be assessed at screening, 2 month, 4 month, and 12 month time points.
Secondary outcomes:
measure: Changes of levels of anxiety
timeFrame: The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in quality of life and enjoyment
timeFrame: The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in work and social adjustment
timeFrame: The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in work functionality and impairment
timeFrame: The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in mental health literacy
timeFrame: The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in use of health services
timeFrame: The CSRI will be asssessed at screening, 4 month, and 12 month time points
measure: Changes in health status
timeFrame: The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in health status and health related quality of life
timeFrame: The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points
measure: Changes in illness severity
timeFrame: The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
measure: Client satisfaction.
timeFrame: The CSQ-9 will be assessed at 4 month time point.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Foothills Primary Care Network
state: Alberta
city: Chinook Valley
country: Canada
facility: Chinook Primary Care Network
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mark Lau, PhD
role: PRINCIPAL_INVESTIGATOR
References: