Clinical trial NCT03659591: Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Keywords: Cognitive Behaviour Therapy
Community Mental Health
Adaptive Psychological Training
Quality of Life
Wellbeing
Treatment
Lead sponsor: Joseph Brant Hospital
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Triple Aim Measure
timeFrame: At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
Secondary outcomes:
measure: Triple Aim Measure - recovery only
timeFrame: At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
measure: Triple Aim Measure - improvement only
timeFrame: At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
measure: Change from baseline - depressive symptoms
timeFrame: Pre- (week 0) and repeated every two weeks across 6 months
measure: Change from baseline - anxiety symptoms
timeFrame: Pre- (week 0) and repeated every two weeks across 6 months
measure: Change from baseline - function
timeFrame: Pre- (week 0) and repeated monthly across 6 months
measure: Change from baseline - mental wellbeing
timeFrame: Pre- (week 0) and repeated monthly across 6 months
measure: Change from baseline - self-compassion
timeFrame: Pre- (week 0) and repeated monthly across 6 months
Other outcomes:
Locations:
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
Study officials:
affiliation: Joseph Brant Hospital
name: Steven Selchen, MD MSt FRCPC
role: PRINCIPAL_INVESTIGATOR
References: