Clinical trial · Interventional
Sophie Pilot Implementation and Assessment
Comparing the Sophie RA-CBT System and Telemedically-delivered CBT: a Pilot Implementation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was not conducted due to concerns about collaboration with an outside vendor for the control condition.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Anxiety | — | UNRESOLVED | — |
| Depression Chronic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iHope CBT | Behavioral | — | UNRESOLVED |
| Sophie CBT System | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sophie CBT
- 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.
- interventionNames
- Behavioral: Sophie CBT System
- type
- ACTIVE_COMPARATOR
- label
- iHope CBT
- 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).
- interventionNames
- Behavioral: iHope CBT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available