Sophie Pilot Implementation and Assessment

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03904342
• Other study ID #: H-37919
• Secondary ID: 4153360
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Anxiety
• Depression
• Depression Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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