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

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.

Study Overview

• Status: Unknown
• Conditions: Depressive Symptoms; Anxiety Symptoms
• Intervention / Treatment: Behavioral: Cognitive Behaviour Therapy; Behavioral: Adaptive Psychological Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Selchen, MD MSt FRCPC; Phone Number: (905) 681-4812; Email: dr.steven.selchen@josephbranthospital.ca
• Study Contact Backup: Name: Benjamin D Diplock, BScH; Email: ben.diplock@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Burlington, Ontario, Canada, L7S OA2
      • Joseph Brant Hospital
      • Contact: Steven Selchen, MD MSt FRCPC; Phone Number: (905) 681-4812; Email: dr.steven.selchen@josephbranthospital.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Behaviour Therapy; 10 week, manual-based group CBT treatment for depression and anxiety, followed by optional booster sessions	Behavioral: Cognitive Behaviour Therapy; CBT will be delivered in group format, consisting of 10 weekly two-hour sessions, with 10 participants per group; Other Names: CBT
Active Comparator: Adaptive Psychological Training; 5 week, manual-based group APT treatment for depression and anxiety, followed by optional booster sessions	Behavioral: Adaptive Psychological Training; APT will be delivered in group format, consisting of 5 weekly two-hour sessions, with 20 participants per group; Other Names: APT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triple Aim Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triple Aim Measure - recovery only	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Joseph Brant Hospital
• Investigators: Principal Investigator: Steven Selchen, MD MSt FRCPC, Joseph Brant Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Wellbeing; Treatment; Quality of Life; Cognitive Behaviour Therapy; Community Mental Health; Adaptive Psychological Training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 000-044-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No