Sophie Pilot Implementation and Assessment

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Advanced Cancer; Depression Chronic; Anxiety

Treatments: Behavioral: Sophie CBT System; Behavioral: iHope CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03904342

4153360 (Other Grant/Funding Number)

H-37919

Details and patient eligibility

About

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.

Full 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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Sophie CBT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sophie CBT System

iHope CBT

Active Comparator group

Description:

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).

Treatment:

Behavioral: iHope CBT