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Evaluation of the Bounce Back Program

8 settembre 2014 aggiornato da: University of British Columbia

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

213

Fase

  • Non applicabile

Contatti e Sedi

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Contatto studio

Luoghi di studio

    • Alberta
      • Calgary, Alberta, Canada, T3G0B4
        • Reclutamento
        • Calgary Foothills Primary Care Network
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Richard Ward, MD
      • Chinook Valley, Alberta, Canada, T1J013
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T2A1
        • Non ancora reclutamento
        • University of British Columbia
        • Investigatore principale:
          • Mark Lau, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TG + GP TAU
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.
Sperimentale: UG + GP TAU
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.
Comparatore attivo: GP TAU
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in levels of depressive symptomatology
Lasso di tempo: 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)
The PHQ-9 will be assessed at screening, 2 month, 4 month, and 12 month time points.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes of levels of anxiety
Lasso di tempo: The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
Levels of anxiety will be measured over tiem, using the Generalized Anxiety Disorder 7 (GAD-7).
The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in quality of life and enjoyment
Lasso di tempo: The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points
Quality of life and enjoyment will be measured over time using the Quality of Life and Enjoyment Satisfaction Questionnaire (QLES-Q-SF).
The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in work and social adjustment
Lasso di tempo: The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
Work and social adjustemnt will be assessed over time, using the Work and Social Adjustment Scale (WASA).
The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in work functionality and impairment
Lasso di tempo: The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
Work functionality and impairment will be assessed over time using the Lam Employment and Productivity Scale (LEAPS).
The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in mental health literacy
Lasso di tempo: The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
Mental health literacy will be measured over time using the Mental Health Literacy questionnaire (MHL-Q).
The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
Changes in use of health services
Lasso di tempo: The CSRI will be asssessed at screening, 4 month, and 12 month time points
Participants' use of health services will be assessed using the Client Service Receipt Inventory - modified (CSRI).
The CSRI will be asssessed at screening, 4 month, and 12 month time points
Changes in health status
Lasso di tempo: The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
Health status will be assessed using the Euroquol-5 (EQ-5D).
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
Lasso di tempo: The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points
Health status and health related quality of life will be assessed over time using the Health Utilities Index (HUI-3).
The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points
Changes in illness severity
Lasso di tempo: The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
Illness severity will be assessed over time using the Duke Severity of Illness Checklist (DUSOI).
The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
Client satisfaction.
Lasso di tempo: The CSQ-9 will be assessed at 4 month time point.
Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).
The CSQ-9 will be assessed at 4 month time point.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mark Lau, PhD, University of British Columbia

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2011

Completamento primario (Anticipato)

1 dicembre 2014

Completamento dello studio (Anticipato)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

14 marzo 2011

Primo inviato che soddisfa i criteri di controllo qualità

28 marzo 2011

Primo Inserito (Stima)

29 marzo 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 settembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2014

Ultimo verificato

1 settembre 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H08-02847
  • 106504 (Altro numero di sovvenzione/finanziamento: Canadian Institute of Health Research)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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