DepressionNCT01324648
Evaluation of the Bounce Back Program
A study testing Telephone-supported self-help and GP treatment as usual, Unsupported self-help and GP treatment as usual and General practitioner treatment as usual in people with Depression, run by University of British Columbia at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Telephone-supported self-help and GP treatment as usual, Unsupported self-help and GP treatment as usual and General practitioner treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Calgary Foothills Primary Care Network
Calgary, Alberta, T3G0B4
Chinook Primary Care Network
Chinook Valley, Alberta, T1J013
University of British Columbia
Vancouver, British Columbia, V6T2A1
About this study
Official title: A Randomized Controlled Trial Evaluation of Brief, Telephone Supported CBT Self-help in Primary Care Patients With Mild to Moderate Depression
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.
Read the 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
- Being tested
- Telephone-supported self-help and GP treatment as usual, Unsupported self-help and GP treatment as usual, General practitioner treatment as usual
- Keywords
- Guided self-help, Telephone delivery, Cognitive behavior therapy, Bibliotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-supported self-help and GP treatment as usualBehavioural
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.
Unsupported self-help and GP treatment as usualBehavioural
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.
General practitioner treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TG + GP TAU | Experimental | Not described Receives: Behavioral: Telephone-supported self-help and GP treatment as usual |
| UG + GP TAU | Experimental | Not described Receives: Behavioral: Unsupported self-help and GP treatment as usual |
| GP TAU | Active comparator | Not described Receives: Other: General practitioner treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in levels of depressive symptomatology
Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)
Measured: 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
Levels of anxiety will be measured over tiem, using the Generalized Anxiety Disorder 7 (GAD-7).
Measured: The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
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).
Measured: The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in work and social adjustment
Work and social adjustemnt will be assessed over time, using the Work and Social Adjustment Scale (WASA).
Measured: The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in work functionality and impairment
Work functionality and impairment will be assessed over time using the Lam Employment and Productivity Scale (LEAPS).
Measured: The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in mental health literacy
Mental health literacy will be measured over time using the Mental Health Literacy questionnaire (MHL-Q).
Measured: The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in use of health services
Participants' use of health services will be assessed using the Client Service Receipt Inventory - modified (CSRI).
Measured: The CSRI will be asssessed at screening, 4 month, and 12 month time points
Changes in health status
Health status will be assessed using the Euroquol-5 (EQ-5D).
Measured: The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
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).
Measured: The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points
Changes in illness severity
Illness severity will be assessed over time using the Duke Severity of Illness Checklist (DUSOI).
Measured: The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
Client satisfaction.
Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).
Measured: The CSQ-9 will be assessed at 4 month time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Couldn't enrol sufficient participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Mental Health Association
- Responsible party
- Sponsor
- Investigators
- Mark Lau, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324648
- Sponsor's protocol ID
- H08-02847
- Other IDs
- 106504
- Status last verified
- May 2022
- First submitted
- 14 Mar 2011
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluation of Brief, Telephone Supported CBT Self-help in Primary Care Patients With Mild to Moderate Depression
- ClinicalTrials.gov ID
- NCT01324648
- Acronym / sponsor ID
- H08-02847
- Conditions
- Depression
- Keywords
- Guided self-help, Telephone delivery, Cognitive behavior therapy, Bibliotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Couldn't enrol sufficient participants
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Mental Health Association
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-supported self-help and GP treatment as usualParticipants' 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. | Behavioural | TG + GP TAU |
| Unsupported self-help and GP treatment as usualThis 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. | Behavioural | UG + GP TAU |
| General practitioner treatment as usualThis 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. | Other | GP TAU |
Primary outcome
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.
Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)
10 secondary outcomes
Changes of levels of anxiety
Time frame: The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
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
Changes in work and social adjustment
Time frame: The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in work functionality and impairment
Time frame: The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in mental health literacy
Time frame: The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in use of health services
Time frame: The CSRI will be asssessed at screening, 4 month, and 12 month time points
Changes in health status
Time frame: The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
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
Changes in illness severity
Time frame: The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
Client satisfaction.
Time frame: The CSQ-9 will be assessed at 4 month time point.
Results and safety
The study was stopped early (reason given: Couldn't enrol sufficient participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lau, PhD principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-supported self-help and GP treatment as usual, Unsupported self-help and GP treatment as usual and General practitioner treatment as usual in people with Depression, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Couldn't enrol sufficient participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.