Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of the Bounce Back Program

8. september 2014 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

213

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Alberta
      • Calgary, Alberta, Canada, T3G0B4
        • Rekruttering
        • Calgary Foothills Primary Care Network
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Richard Ward, MD
      • Chinook Valley, Alberta, Canada, T1J013
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T2A1
        • Har ikke rekruttert ennå
        • University of British Columbia
        • Hovedetterforsker:
          • Mark Lau, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Eksperimentell: 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.
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in levels of depressive symptomatology
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes of levels of anxiety
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mark Lau, PhD, University of British Columbia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2011

Primær fullføring (Forventet)

1. desember 2014

Studiet fullført (Forventet)

1. desember 2014

Datoer for studieregistrering

Først innsendt

14. mars 2011

Først innsendt som oppfylte QC-kriteriene

28. mars 2011

Først lagt ut (Anslag)

29. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H08-02847
  • 106504 (Annet stipend/finansieringsnummer: Canadian Institute of Health Research)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

3
Abonnere