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

2018년 9월 3일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

80

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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
다른 이름들:
  • CBT
활성 비교기: 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
다른 이름들:
  • 적절한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Triple Aim Measure
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Triple Aim Measure - recovery only
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Steven Selchen, MD MSt FRCPC, Joseph Brant Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2018년 9월 1일

기본 완료 (예상)

2019년 8월 1일

연구 완료 (예상)

2019년 11월 1일

연구 등록 날짜

최초 제출

2018년 8월 30일

QC 기준을 충족하는 최초 제출

2018년 9월 3일

처음 게시됨 (실제)

2018년 9월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 3일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 000-044-18

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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