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Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms

19 settembre 2018 aggiornato da: Sunnybrook Health Sciences Centre

Reducing Barriers to Mental Health Care: Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms in a Heterogeneous Clinical Outpatient Group

Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. The goal of this project is to test the effectiveness of an Abbreviated MBT (<10 hours of clinical time and <10 hours of homework) in reducing symptoms of depression/anxiety and improving wellbeing. If effective, this Abbreviated MBT could reduce barriers to accessing mental health care.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

BACKGROUND: ABBREVIATED-MINDFULNESS BASED INTERVENTION (A-MBI)

By the age of 40, 1 in 2 Canadians have been or are presently experiencing mental health issues. In particular, anxiety and mood disorders are the most prevalent lifetime mental health illnesses, affecting 11.6% of the population. Mindfulness based treatments (MBTs) have strong evidence for improving patient wellness through reduction of anxiety and mood symptoms in clinical populations. Although efficacious, 'traditional' MBTs are very demanding in terms of time and homework a relevant factor when considering the recent calls for wait time reductions in psychotherapeutic mental health services. These programs take 30+ hours (including 2-3 hr. weekly sessions across 8 weeks, plus a 1-day retreat) and expect 45-60 min./day of meditation homework. The goal of this project is to test the effectiveness of an abbreviated MBI in reducing anxiety and/or mood disturbances and improving patient well-being.

MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways. Participants in MBI often describe the intervention as transformative. Professional experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop a effective and accessible clinical intervention. This abbreviated MBT has been developed, which if effective will curtail wait-times and increase patient treatment annually.

RATIONAL & HYPOTHESIS/RESEARCH QUESTION

Rational

Patients face barriers to accessing psychotherapy, including long wait-times and/or protocols that are too demanding for many patients. Traditional Mindfulness-Based Therapies (MBTs) are highly studied and well-recognized treatment options to reduce anxiety and mood symptoms - demonstrating repeated efficacy in clinical populations. However, the high demands of clinical time and homework are a barrier to many patients. Further, longer clinical interventions mean fewer patients being treated per hour of clinician's time, and therefore longer wait-times. Clinical experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop an effective and more accessible therapy. If this Abbreviated MBT is demonstrated to be clinically effective, it can reduce barriers to mental health care by reaching more patients in a more timely fashion.

The specific objective of this study will be to evaluate a novel and potentially highly effective strategy to reduce symptoms of depression, anxiety and improve quality of life among outpatients in the chosen pilot site, the Odette Cancer Centre.

Hypothesis/Research Question

The overall study hypothesis is that patients participating in an Abbreviated MBT will show improvement in self-reported measures of clinical primary (Depression, Anxiety) and secondary (well-being) outcomes. Improvement will be determined by effect size (magnitude of change ≥0.2) based on the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BDI).

Study Significance

The current pilot study will explore the effects of an Abbreviated-MBT on symptoms of depression and anxiety in an outpatient clinical sample; if effective: a) this would be the first known pilot study to consider and demonstrate efficacy of an Abbreviated-MBT in a clinical outpatient population; b) this treatment could increase the volume of patients treated by up to 3x, reduce wait-times by 2-3 fold, and reach a broader group of patients, including those for whom the investment of time of traditional MBT is too prohibitive.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

54

Fase

  • Non applicabile

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook Mindfulness-Based Therapy Clinic
  • Due to the nature of the assessment procedures, which include English-language self-report questionnaires and scales, ability to communicate in written and spoken English is an inclusion criterion

Exclusion Criteria:

  • Patients who have active or recent (within 3 months) substance abuse/dependence, a history of dementia, untreated posttraumatic stress symptoms, active psychotic or manic symptoms, recent suicide attempt/active suicidality, or current self-injurious behaviour
  • Previously completed a course (≥ 8 weeks) of a Mindfulness-Based Therapy within the last 3 years

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: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Mindfulness-based Intervention
6 week, abbreviated group MBI treatment for depression and anxiety
MBI will be delivered in group format, 120 minutes per week, for 6 consecutive weeks with 10-20 participants per group.
Altri nomi:
  • MBI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline Depressive Symptoms at 6 Weeks
Lasso di tempo: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Scale used to measure Depressive Symptoms: Beck Depression Inventory II (BDI-II)
Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Change from Baseline Anxiety Symptoms at 6 Weeks
Lasso di tempo: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Scale used to measure Anxiety Symptoms: Generalized Anxiety Disorder 7 (GAD-7).
Pre- (Week 0) and Post-Treatment Assessment (Week 6)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline Anxiety Symptoms at 6 Weeks
Lasso di tempo: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Scale used to measure Anxiety Symptoms: Beck Anxiety Inventory (BAI)
Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Change from Baseline Mental Wellbeing at 6 Weeks
Lasso di tempo: Pre- (Week 0) and Post-Treatment Assessment (Week 6)
Scale used to measure Mental Wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Pre- (Week 0) and Post-Treatment Assessment (Week 6)

Collaboratori e investigatori

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

Sponsor

Investigatori

  • Investigatore principale: Steven Selchen, MD MSt FRCPC, Sunnybrook Health Sciences Centre

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 agosto 2016

Completamento primario (Effettivo)

1 marzo 2017

Completamento dello studio (Effettivo)

1 marzo 2017

Date di iscrizione allo studio

Primo inviato

5 agosto 2016

Primo inviato che soddisfa i criteri di controllo qualità

5 agosto 2016

Primo Inserito (Stima)

10 agosto 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 settembre 2018

Ultimo verificato

1 settembre 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 387-2105

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 .