Evaluation of the Bounce Back Program

NCT01324648 | Terminated DMC

• 2 other identifiers: H08-02847106504
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression

Keywords

Guided self-help; Telephone delivery; Cognitive behavior therapy; Bibliotherapy

Outcome Measures

Primary Outcomes (1)

• Changes in levels of depressive symptomatology

  Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)

  The PHQ-9 will be assessed at screening, 2 month, 4 month, and 12 month time points.

Secondary Outcomes (10)

• Changes of levels of anxiety

  The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points

• Changes in quality of life and enjoyment

  The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points

• Changes in work and social adjustment

  The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points

• Changes in work functionality and impairment

  The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points

• Changes in mental health literacy

  The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points

Study Arms (3)

TG + GP TAU

EXPERIMENTAL

Behavioral: Telephone-supported self-help and GP treatment as usual

UG + GP TAU

EXPERIMENTAL

Behavioral: Unsupported self-help and GP treatment as usual

GP TAU

ACTIVE COMPARATOR

Other: General practitioner treatment as usual

Interventions

Telephone-supported self-help and GP treatment as usual 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.

TG + GP TAU

Unsupported self-help and GP treatment as usual 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.

UG + GP TAU

General practitioner treatment as usual 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.

GP TAU

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently experiencing a mild to moderate level of depressive symptoms as defined by a score of 5 - 19 on the PHQ-9;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Mental Health Association: collaborator

Study Sites (3)

Calgary Foothills Primary Care Network

Calgary, Alberta, T3G0B4, Canada

Location

Chinook Primary Care Network

Chinook Valley, Alberta, T1J013, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T2A1, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mark Lau, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 29, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 13, 2026

Record last verified: 2022-05

Locations

CA (3)