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Sophie Pilot Implementation and Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03904342
Recruitment Status : Withdrawn (This study was not conducted due to concerns about collaboration with an outside vendor for the control condition.)
First Posted : April 5, 2019
Last Update Posted : December 1, 2020
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Depression Chronic Advanced Cancer Anxiety Behavioral: Sophie CBT System Behavioral: iHope CBT Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparing the Sophie RA-CBT System and Telemedically-delivered CBT: a Pilot Implementation Study
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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).
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.

Primary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: baseline, 8 weeks ]
    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

Secondary Outcome Measures :
  1. Change in anxiety [ Time Frame: baseline, 8 weeks ]
    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.

  2. Change in coping [ Time Frame: baseline, 8 weeks ]
    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.

  3. Changes in quality of life [ Time Frame: baseline, 8 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03904342

Sponsors and Collaborators
Boston Medical Center
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Principal Investigator: Suzanne Mitchell, MD Boston Medical Center
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Responsible Party: Boston Medical Center Identifier: NCT03904342    
Other Study ID Numbers: H-37919
4153360 ( Other Grant/Funding Number: CIIS Evans Center )
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Cognitive behavioral therapy (CBT)
Sophie CBT
iHope CBT
Consolidated Framework for Implementation Research (CFIR)
Additional relevant MeSH terms:
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Behavioral Symptoms