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

3. september 2018 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andre navne:
  • CBT
Aktiv komparator: 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
Andre navne:
  • APT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Triple Aim Measure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Triple Aim Measure - recovery only
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Steven Selchen, MD MSt FRCPC, Joseph Brant Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. september 2018

Primær færdiggørelse (Forventet)

1. august 2019

Studieafslutning (Forventet)

1. november 2019

Datoer for studieregistrering

Først indsendt

30. august 2018

Først indsendt, der opfyldte QC-kriterier

3. september 2018

Først opslået (Faktiske)

6. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depressive symptomer

Kliniske forsøg med Cognitive Behaviour Therapy

Abonner