Sophie Pilot Implementation and Assessment

Comparing the Sophie RA-CBT System and Telemedically-delivered CBT: a Pilot Implementation Study

Evidence-based interventions using cognitive behavioral therapy (CBT) and self-management education have been demonstrated to effectively treat symptoms of depression and improve the quality of life in populations with chronic illness. Research indicates that CBT is the most effective psychosocial treatment for depression; as effective as pharmacotherapy and as effective as adding another medication for patients who do not respond to one antidepressant alone. Despite the existence of proven efficacious treatments for depression, however, fewer than half of patients for whom depression treatment is indicated receive the services they need. Access barriers (i.e., transportation, insurance coverage), limited clinician availability (i.e., long waitlists, difficulty finding a provider), and competing (and time-consuming) medical priorities contribute to inadequate depression treatment for individuals with serious chronic illness. In this research the investigators will conduct a pilot randomized trial to compare results from implementation of two CBT strategies iHope and Sophie.

Study Overview

• Status: Withdrawn
• Conditions: Anxiety; Advanced Cancer; Depression Chronic
• Intervention / Treatment: Behavioral: Sophie CBT System; Behavioral: iHope CBT

Detailed Description

A pre-implementation pilot study will be conducted with 20 adult patients diagnosed with advanced (Stage 3 or 4) cancer who screen positive for moderate depression and are receiving care at the Solomont Center for Hematology and Medical Oncology at Boston Medical Center (BMC) with the following specific aims:

1. Using the Consolidated Framework for Implementation Research (CFIR) as a guide, design a pilot implementation strategy for introducing the Sophie CBT system and iHope system into the clinical context of care (Months 1-4)
2. Conduct a pre-implementation pilot study with randomization of 20 cancer patients who screen positive for depression and/or anxiety into two arms with Sophie CBT or iHope telemedicine (10 participants each) to: a) assess the feasibility, acceptability, and appropriateness of implementing the Sophie CBT and iHope interventions in an ambulatory cancer treatment center and b) evaluate the potential impact of the Sophie CBT and iHope interventions on measures of depression, anxiety, coping, and quality of life for cancer patients with comorbid depression (Months 5-10)

• Study Type: Interventional
• Phase: Not Applicable

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:

• Diagnosed with stage 3 or 4 cancer receiving care at Solomont Cancer Center
• GAD score >10 AND/OR positive screening for moderate to severe depressive symptoms (PHQ-8>9).
• Comfortable using tablet, phone and computer
• Has telephone access
• Speaks English
• Lives in greater Boston area

Exclusion Criteria:

• Patients without the capacity to provide informed consent
• Ongoing substance use disorder
• Patients with Schizophrenia and Dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sophie CBT; The Sophie Cognitive Behavioral Therapy (CBT) intervention is a tablet-based computerized CBT and self-management education intervention that consists of an evidence-based cognitive behavioral therapy self-management curriculum divided into 6 discrete modules. Patients will have up to 8 weeks to work through the modules on the tablet.	Behavioral: Sophie CBT System; The Sophie CBT system is a tablet-based system that delivers self-paced cognitive behavioral therapy educational curriculum in the format of 6 discrete modules.
Active Comparator: iHope CBT; iHope CBT is a telemedically-delivered CBT package. The iHope system comprises a HIPAA-compliant platform on which real, live, licensed clinicians provide cognitive behavioral therapy via video conferencing, phone calls, and text messaging. iHope will be delivered on subjects' preferred electronic device (mobile phone, laptop, tablet).	Behavioral: iHope CBT; Licensed therapists will use the iHope HIPAA-compliant telemedicine platform to deliver cognitive behavioral therapy to patients via telephone, videoconferencing, and/or text chat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms	Changes in depressive symptoms will be measured using the PHQ-8, which is an 8-item scale with scores ranging from 0 to 24, with higher scores indicative of more depressive symptoms	baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	The Generalized Anxiety Disorder 7 (GAD-7) will be used to assess changes in anxiety. The GAD-7 is a 7-item questionnaire that asks how often an individual has been bothered by a given item over the last 2 weeks. Scores range from 0 ("not at all") to 3 ("nearly every day.") A higher overall score indicates a greater level of anxiety.	baseline, 8 weeks
Change in coping	Changes in coping will be assessed using the Ways of Coping scale which is a 66 item scale with potential responses from 1 to 4, with higher scores indicative of more frequent use of a particular strategy.	baseline, 8 weeks
Changes in quality of life	Changes in quality of life will be assessed using the Quality of Life Scale (QOLS), which is a 15-item scale with potential responses ranging from 1 to 7, with higher scores indicating a higher level of satisfaction with quality of life.	baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Suzanne Mitchell, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 29, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy (CBT); Sophie CBT; iHope CBT; Consolidated Framework for Implementation Research (CFIR)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: H-37919; 4153360 (Other Grant/Funding Number: CIIS Evans Center)

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