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Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost (TAP)

3 septembre 2018 mis à jour par: Dr. Steven Selchen, Joseph Brant Hospital

Triple Aim Psychotherapy: an RCT Comparing Cognitive Behaviour Therapy (CBT) to Adaptive Psychological Training (APT) - a Treatment Aimed at Improving Patient Experience, Population Health, and Cost-effectiveness

Community mental health programs in publically-funded jurisdictions such as Canada often have limited budgets in order to provide services, which can result in inadequate access to effective treatment for patients. Cognitive Behaviour Therapy (CBT) is a gold-standard psychotherapy for depression and anxiety. In order to improve access to treatment, community mental healthcare settings often provide CBT in a group format for patients experiencing mild-to-moderate symptoms. However, typical protocols for delivering group CBT in a community setting nonetheless require a considerable investment of limited clinician time. The Institute for Healthcare Improvement (IHI) developed the Triple Aim, which is a framework describing an approach to optimizing health system performance by simultaneously pursuing three dimensions, namely improving the patient experience of care; improving the health of populations; and reducing the associated per capita costs of care. Adaptive Psychological Training (APT) is a group-based psychotherapy designed with all of the dimensions of the Triple Aim in mind simultaneously. In its development, APT drew heavily upon mindfulness-based approaches. To-date, APT has already demonstrated positive outcomes in pilot research and in community clinical settings. The purpose of the current study is to determine whether for a given population of patients experiencing mild-to-moderate symptoms of depression and/or anxiety, APT can facilitate meaningful change for more patients per time spent by clinicians than can CBT.

Aperçu de l'étude

Description détaillée

Depression and anxiety are highly prevalent in the general population. Community mental health programs in publically-funded jurisdictions such as Canada often have relatively limited, fixed budgets in order to provide services, which can result in inadequate access to effective treatment for patients. Cognitive Behaviour Therapy (CBT) is a gold-standard psychotherapeutic treatment for depression and anxiety. In order to improve access to treatment, community mental healthcare settings often provide CBT in a group format for patients experiencing mild-to-moderate symptoms. However, typical protocols for delivering group CBT in a community setting nonetheless require a considerable investment of limited clinician time.

The question arises as to whether this is the most efficient and effective use of clinician time; in other words, per hour spent of clinician time, does this approach maximize the number of patients experiencing adequate and meaningful clinical improvement? The Institute for Healthcare Improvement (IHI) developed the Triple Aim, which is a framework describing an approach to optimizing health system performance by simultaneously pursuing three dimensions, namely improving the patient experience of care; improving the health of populations; and reducing the associated per capita costs of care. Studies of psychotherapy rarely pursue all three of these dimensions simultaneously. Efforts to achieve the best clinical outcome for an individual often lead to restrictive inclusionary/exclusionary criteria that sacrifice reaching the wider population; conversely, efforts to improve population health often prioritize composite overall clinical improvement across an entire group, even though the change experienced by many of the individuals in the population might not be clinically meaningful; focusing primarily on cost-effectiveness often sacrifices the individual's experience and/or the population's needs.

Adaptive Psychological Training (APT) is a group-based psychotherapy designed with all of the dimensions of the Triple Aim in mind simultaneously. In its development, APT drew heavily upon Mindfulness-Based Cognitive Therapy, an evidence-based psychotherapy that itself draws upon both evidence-based eastern psychotherapeutic practices and CBT, but APT also drew upon other evidence-based and evidence-supported psychotherapies including interpersonal and relational approaches, as well as meaning-focused psychoanalytic models. It also drew from psychology and neuroscience more broadly, as well as from learning theory and from practical clinical and operational experience. Inclusion/exclusion criteria, group size, number of sessions, in-session practice and learning, and between-session practice and learning were all adapted from the perspective of trying to achieve high quality outcomes for a broader population within more contained costs, and thereby increase access to quality care.

To-date, APT has already demonstrated positive outcomes in pilot research and in community clinical settings. The purpose of this specific study is to determine whether for a given population of patients experiencing mild-to-moderate symptoms of depression and/or anxiety, APT can facilitate meaningful change for more patients per time spent by clinicians than can CBT (the gold standard). The significance of this study includes its potential contribution to determining how best to deploy the limited resource of clinician time in a community setting in order to best help the most people.

Type d'étude

Interventionnel

Inscription (Anticipé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Ontario
      • Burlington, Ontario, Canada, L7S OA2
        • Joseph Brant Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Treatment-seeking adults, interested and willing to participate in group psychotherapy
  • Mild-to-moderate depressive (score of ≥10 and <20 on PHQ9) and/or anxious (score of ≥8 and <15 on GAD7) symptoms
  • Ability to communicate, in written and spoken English

Exclusion Criteria:

  • Severe depressive/anxious symptoms
  • Patients where the primary clinical focus is active suicidality or harm-to-others, psychosis, mania, substance use, posttraumatic stress, or personality pathology such that it would interfere with group function
  • Recent course(s) of the study psychotherapies

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Cognitive Behaviour Therapy
10 week, manual-based group CBT treatment for depression and anxiety, followed by optional booster sessions
CBT will be delivered in group format, consisting of 10 weekly two-hour sessions, with 10 participants per group
Autres noms:
  • TCC
Comparateur actif: Adaptive Psychological Training
5 week, manual-based group APT treatment for depression and anxiety, followed by optional booster sessions
APT will be delivered in group format, consisting of 5 weekly two-hour sessions, with 20 participants per group
Autres noms:
  • APTE

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Triple Aim Measure
Délai: At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
Numerator: The number of patients achieving reliable recovery; denominator: clinician time spent in hours ('reliable recovery' is defined as scores below 'caseness' for both depression [<10 on Patient Health Questionnaire (PHQ-9)] and anxiety [<8 on Generalized Anxiety Disorder-7 (GAD-7)], with any change from above caseness to below caseness meeting the threshold of the Reliable Change Index)
At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Triple Aim Measure - recovery only
Délai: At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
Triple Aim Composite Score (as above), but without the Reliable Change Index requirement
At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
Triple Aim Measure - improvement only
Délai: At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
Triple Aim Composite Score (as above), but without the remission requirement
At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
Change from baseline - depressive symptoms
Délai: Pre- (week 0) and repeated every two weeks across 6 months
Scale used to measure depressive symptoms is the Patient Health Questionnaire (PHQ-9); score ranges from 0-27, where higher values indicate more depressive symptoms (worse outcome)
Pre- (week 0) and repeated every two weeks across 6 months
Change from baseline - anxiety symptoms
Délai: Pre- (week 0) and repeated every two weeks across 6 months
Scale used to measure anxiety symptoms is the Generalized Anxiety Disorder 7-item (GAD-7) Scale; score ranges from 0-21, where higher values indicate more anxiety symptoms (worse outcome)
Pre- (week 0) and repeated every two weeks across 6 months
Change from baseline - function
Délai: Pre- (week 0) and repeated monthly across 6 months
Scale used to measure function is the World Health Organization Disability Assessment Schedule 2.0 - 12 item version (WHODAS 2.0 12-item); score ranges from 0-48, where higher values indicate lower functioning (worse outcome)
Pre- (week 0) and repeated monthly across 6 months
Change from baseline - mental wellbeing
Délai: Pre- (week 0) and repeated monthly across 6 months
Scale used to measure mental wellbeing is the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); score ranges from 14-70, where higher values indicate greater mental wellbeing (better outcome)
Pre- (week 0) and repeated monthly across 6 months
Change from baseline - self-compassion
Délai: Pre- (week 0) and repeated monthly across 6 months
Scale used to measure self-compassion is the Self-Compassion Scale - Short Form (SCS-SF); score ranges from 12-60, where higher values indicate greater self-compassion (better outcome)
Pre- (week 0) and repeated monthly across 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Steven Selchen, MD MSt FRCPC, Joseph Brant Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 septembre 2018

Achèvement primaire (Anticipé)

1 août 2019

Achèvement de l'étude (Anticipé)

1 novembre 2019

Dates d'inscription aux études

Première soumission

30 août 2018

Première soumission répondant aux critères de contrôle qualité

3 septembre 2018

Première publication (Réel)

6 septembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 septembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2018

Dernière vérification

1 septembre 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 000-044-18

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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