- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01324648
Evaluation of the Bounce Back Program
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
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mark Lau, PhD
- Numero di telefono: 604-707-6358
- Email: mlau4@bcmhs.bc.ca
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T3G0B4
- Reclutamento
- Calgary Foothills Primary Care Network
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Contatto:
- Lorraine Bucholtz
- Numero di telefono: 403-284-3726
- Email: Lorraine.Bucholtz@cfpcn.ca
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Contatto:
- Richard Ward, MD
- Email: raward@direct.ca
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Sub-investigatore:
- Richard Ward, MD
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Chinook Valley, Alberta, Canada, T1J013
- Reclutamento
- Chinook Primary Care Network
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Contatto:
- Lisa Cook, PhD
- Email: lisa.cook@albertahealthservices.ca
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Contatto:
- Robert Wedel, MD
- Email: rwedel@telusplanet.net
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Investigatore principale:
- Robert Wedel, MD
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British Columbia
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Vancouver, British Columbia, Canada, V6T2A1
- Non ancora reclutamento
- University of British Columbia
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Investigatore principale:
- Mark Lau, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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
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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.
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Sperimentale: UG + GP TAU
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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.
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Comparatore attivo: GP TAU
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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.
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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.
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Levels of depressive symptomatology will be measured over time, using the Patient Health Questionnaire (PHQ-9)
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The PHQ-9 will be assessed at screening, 2 month, 4 month, and 12 month time points.
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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
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Levels of anxiety will be measured over tiem, using the Generalized Anxiety Disorder 7 (GAD-7).
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The GAD-7 will be assessed at baseline, 2 month, 4 month, and 12 month time points
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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
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Quality of life and enjoyment will be measured over time using the Quality of Life and Enjoyment Satisfaction Questionnaire (QLES-Q-SF).
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The QLES-Q-SF will be assessed at baseline, 2 month, 4 month, and 12 month time points
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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
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Work and social adjustemnt will be assessed over time, using the Work and Social Adjustment Scale (WASA).
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The WASA will be assessed at baseline, 2 month, 4 month, and 12 month time points
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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
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Work functionality and impairment will be assessed over time using the Lam Employment and Productivity Scale (LEAPS).
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The LEAPS will be assessed at baseline, 2 month, 4 month, and 12 month time points
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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
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Mental health literacy will be measured over time using the Mental Health Literacy questionnaire (MHL-Q).
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The MHL-Q will be assessed at baseline, 2 month, 4 month, and 12 month time points
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Changes in use of health services
Lasso di tempo: The CSRI will be asssessed at screening, 4 month, and 12 month time points
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Participants' use of health services will be assessed using the Client Service Receipt Inventory - modified (CSRI).
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The CSRI will be asssessed at screening, 4 month, and 12 month time points
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Changes in health status
Lasso di tempo: The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
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Health status will be assessed using the Euroquol-5 (EQ-5D).
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The EQ-5D will be assessed at baseline, 2 month, 4 month, and 12 month time points
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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
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Health status and health related quality of life will be assessed over time using the Health Utilities Index (HUI-3).
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The HUI-3 will be assesed at baseline, 2 month, 4 month, and 12 month time points
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Changes in illness severity
Lasso di tempo: The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
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Illness severity will be assessed over time using the Duke Severity of Illness Checklist (DUSOI).
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The DUSOI will be assessed at baseline, 2 month, 4 month, and 12 month time points
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Client satisfaction.
Lasso di tempo: The CSQ-9 will be assessed at 4 month time point.
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Client satisfaction will be assessed using the Client Satisfaction Questionnaire 9 (CSQ-9).
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The CSQ-9 will be assessed at 4 month time point.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mark Lau, PhD, University of British Columbia
Pubblicazioni e link utili
Collegamenti utili
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Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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 .