Study Stopped
This study was not conducted due to concerns about collaboration with an outside vendor for the control condition.
Sophie Pilot Implementation and Assessment
Comparing the Sophie RA-CBT System and Telemedically-delivered CBT: a Pilot Implementation Study
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
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Started Jan 2021
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 1, 2020
November 1, 2020
11 months
April 3, 2019
November 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in anxiety
baseline, 8 weeks
Change in coping
baseline, 8 weeks
Changes in quality of life
baseline, 8 weeks
Study Arms (2)
Sophie CBT
ACTIVE COMPARATORThe 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.
iHope CBT
ACTIVE COMPARATORiHope 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).
Interventions
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.
Licensed therapists will use the iHope HIPAA-compliant telemedicine platform to deliver cognitive behavioral therapy to patients via telephone, videoconferencing, and/or text chat.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients without the capacity to provide informed consent
- Ongoing substance use disorder
- Patients with Schizophrenia and Dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Mitchell, MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 5, 2019
Study Start
January 1, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
December 1, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share