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

NCT03659591 | Unknown

• 1 other identifier: 000-044-18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Symptoms; Depressive Symptoms

Keywords

Cognitive Behaviour Therapy; Community Mental Health; Adaptive Psychological Training; Quality of Life; Wellbeing; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Triple Aim Measure - recovery only

  At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months

• Triple Aim Measure - improvement only

  At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months

• Change from baseline - depressive symptoms

  Pre- (week 0) and repeated every two weeks across 6 months

• Change from baseline - anxiety symptoms

  Pre- (week 0) and repeated every two weeks across 6 months

• Change from baseline - function

  Pre- (week 0) and repeated monthly across 6 months

Study Arms (2)

Cognitive Behaviour Therapy

ACTIVE COMPARATOR

10 week, manual-based group CBT treatment for depression and anxiety, followed by optional booster sessions

Behavioral: Cognitive Behaviour Therapy

Adaptive Psychological Training

ACTIVE COMPARATOR

5 week, manual-based group APT treatment for depression and anxiety, followed by optional booster sessions

Behavioral: Adaptive Psychological Training

Interventions

Cognitive Behaviour Therapy BEHAVIORAL

CBT will be delivered in group format, consisting of 10 weekly two-hour sessions, with 10 participants per group

Also known as: CBT

Cognitive Behaviour Therapy

Adaptive Psychological Training BEHAVIORAL

APT will be delivered in group format, consisting of 5 weekly two-hour sessions, with 20 participants per group

Also known as: APT

Adaptive Psychological Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Brant Hospital: lead

Study Sites (1)

Joseph Brant Hospital

Burlington, Ontario, L7S OA2, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy; APT

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Steven Selchen, MD MSt FRCPC

  Joseph Brant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Selchen, MD MSt FRCPC

CONTACT

(905) 681-4812; dr.steven.selchen@josephbranthospital.ca

Benjamin D Diplock, BScH

CONTACT

ben.diplock@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychiatry

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 6, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)