MedDataX Logo

Sophie Pilot Implementation and Assessment

NCT ID: NCT03904342

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Chronic Advanced Cancer Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cognitive behavioral therapy (CBT) Sophie CBT iHope CBT Consolidated Framework for Implementation Research (CFIR)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Sophie CBT System

Intervention Type BEHAVIORAL

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

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).

Group Type ACTIVE_COMPARATOR

iHope CBT

Intervention Type BEHAVIORAL

Licensed therapists will use the iHope HIPAA-compliant telemedicine platform to deliver cognitive behavioral therapy to patients via telephone, videoconferencing, and/or text chat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suzanne Mitchell, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4153360

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-37919

Identifier Type: -

Identifier Source: org_study_id