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Evaluation of the Bounce Back Program

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone-supported self-help and GP treatment as usual
Unsupported self-help and GP treatment as usual
General practitioner treatment as usual
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Guided self-help, Telephone delivery, Cognitive behavior therapy, Bibliotherapy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Calgary Foothills Primary Care NetworkRecruiting
  • Chinook Primary Care NetworkRecruiting
  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

TG + GP TAU

UG + GP TAU

GP TAU

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of levels of anxiety
Levels of anxiety will be measured over tiem, using the Generalized Anxiety Disorder 7 (GAD-7).
Changes in quality of life and enjoyment
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
Work and social adjustemnt will be assessed over time, using the Work and Social Adjustment Scale (WASA).
Changes in work functionality and impairment
Work functionality and impairment will be assessed over time using the Lam Employment and Productivity Scale (LEAPS).
Changes in mental health literacy
Mental health literacy will be measured over time using the Mental Health Literacy questionnaire (MHL-Q).
Changes in use of health services
Participants' use of health services will be assessed using the Client Service Receipt Inventory - modified (CSRI).
Changes in health status
Health status will be assessed using the Euroquol-5 (EQ-5D).
Changes in health status and health related quality of life
Health status and health related quality of life will be assessed over time using the Health Utilities Index (HUI-3).
Changes in illness severity
Illness severity will be assessed over time using the Duke Severity of Illness Checklist (DUSOI).
Client satisfaction.
Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).

Full Information

First Posted
March 14, 2011
Last Updated
September 8, 2014
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Mental Health Association
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1. Study Identification

Unique Protocol Identification Number
NCT01324648
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Mental Health Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Guided self-help, Telephone delivery, Cognitive behavior therapy, Bibliotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TG + GP TAU
Arm Type
Experimental
Arm Title
UG + GP TAU
Arm Type
Experimental
Arm Title
GP TAU
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Telephone-supported self-help and GP treatment as usual
Intervention Description
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
Intervention Name(s)
Unsupported self-help and GP treatment as usual
Intervention Description
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
Other
Intervention Name(s)
General practitioner treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in levels of depressive symptomatology
Description
Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)
Time Frame
The PHQ-9 will be assessed at screening, 2 month, 4 month, and 12 month time points.
Secondary Outcome Measure Information:
Title
Changes of levels of anxiety
Description
Levels of anxiety will be measured over tiem, using the Generalized Anxiety Disorder 7 (GAD-7).
Time Frame
The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in quality of life and enjoyment
Description
Quality of life and enjoyment will be measured over time using the Quality of Life and Enjoyment Satisfaction Questionnaire (QLES-Q-SF).
Time Frame
The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in work and social adjustment
Description
Work and social adjustemnt will be assessed over time, using the Work and Social Adjustment Scale (WASA).
Time Frame
The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in work functionality and impairment
Description
Work functionality and impairment will be assessed over time using the Lam Employment and Productivity Scale (LEAPS).
Time Frame
The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in mental health literacy
Description
Mental health literacy will be measured over time using the Mental Health Literacy questionnaire (MHL-Q).
Time Frame
The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in use of health services
Description
Participants' use of health services will be assessed using the Client Service Receipt Inventory - modified (CSRI).
Time Frame
The CSRI will be asssessed at screening, 4 month, and 12 month time points
Title
Changes in health status
Description
Health status will be assessed using the Euroquol-5 (EQ-5D).
Time Frame
The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in health status and health related quality of life
Description
Health status and health related quality of life will be assessed over time using the Health Utilities Index (HUI-3).
Time Frame
The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points
Title
Changes in illness severity
Description
Illness severity will be assessed over time using the Duke Severity of Illness Checklist (DUSOI).
Time Frame
The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
Title
Client satisfaction.
Description
Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).
Time Frame
The CSQ-9 will be assessed at 4 month time point.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Lau, PhD
Phone
604-707-6358
Email
mlau4@bcmhs.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lau, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary Foothills Primary Care Network
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3G0B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorraine Bucholtz
Phone
403-284-3726
Email
Lorraine.Bucholtz@cfpcn.ca
First Name & Middle Initial & Last Name & Degree
Richard Ward, MD
Email
raward@direct.ca
First Name & Middle Initial & Last Name & Degree
Richard Ward, MD
Facility Name
Chinook Primary Care Network
City
Chinook Valley
State/Province
Alberta
ZIP/Postal Code
T1J013
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Cook, PhD
Email
lisa.cook@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Robert Wedel, MD
Email
rwedel@telusplanet.net
First Name & Middle Initial & Last Name & Degree
Robert Wedel, MD
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T2A1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Lau, PhD

12. IPD Sharing Statement

Links:
URL
http://www.cmha.bc.ca/bounceback
Description
Related Info

Learn more about this trial

Evaluation of the Bounce Back Program

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