Clinical trial NCT03904342: Sophie Pilot Implementation and Assessment
Official title: Comparing the Sophie RA-CBT System and Telemedically-delivered CBT: a Pilot Implementation Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression Chronic
Advanced Cancer
Anxiety
Keywords: Cognitive behavioral therapy (CBT)
Sophie CBT
iHope CBT
Consolidated Framework for Implementation Research (CFIR)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in anxiety
timeFrame: baseline, 8 weeks
measure: Change in coping
timeFrame: baseline, 8 weeks
measure: Changes in quality of life
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Suzanne Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: