Recruiting

Psychotherapy with AI

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07167056

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care Psychotherapy

WYSA App

Study Details

Brief summary:

This research study is for people who are diagnosed with cancer and are receiving treatment for cancer who may benefit from psychotherapy. The purpose of the study is to see whether an artificial intelligence (AI) powered application (app) could help improve quality of life, anxiety symptoms, and/or depression symptoms, over the course of psychotherapy sessions. Participants in this study will be randomly assigned to one of two groups. One group will receive psychotherapy per usual care and will receive access to the AI-powered app. The second group will only receive psychotherapy per usual care and will NOT receive access to the AI-powered app. Both groups will complete surveys about their quality of life, anxiety symptoms, and depression symptoms over the course of their psychotherapy visits.

Conditions

Cancer

Study ID

NCT07167056

Start date

Nov 17, 2025

Status verified date

May, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants in active cancer treatment (receiving chemotherapy, immunotherapy and/or radiation therapy) AND reporting National Comprehensive Cancer Network (NCCN) Distress Thermometer scores ≥4. The NCCN Distress Thermometer is a validated, single-item screening tool routinely used in cancer care at Cleveland Clinic Florida to identify individuals experiencing psychological distress. A score of 4 or higher indicates clinically significant distress and serves as the eligibility threshold for enrollment in this study.
  • Participants followed by a medical oncologist, radiation oncologist, and/or surgical oncologist of any subspecialty at Cleveland Clinic Florida and have no barrier to receive psychotherapy care (e.g. no insurance restrictions)
  • Participants with biopsy proven cancer of any type, stages I-III.
  • Adults aged 18 years or older.
  • Able to understand and read English and/or Spanish.
  • Participants who own a smartphone compatible with the mobile app (Android or IOS) or have regular (Daily) access to one.
  • Participants who are willing and able to provide informed consent.

Exclusion Criteria:

  • Age <18 years.
  • Participants with stage 4 cancer.
  • Participants with active severe psychiatric conditions identified by the Cleveland Clinic psychotherapist as any diagnoses that could significantly impair a participant's ability to engage meaningfully with the intervention or provide informed consent. These include, but are not limited to:

  • Current or recent (within the past 6 months) psychotic disorders (e.g., schizophrenia, schizoaffective disorder)
  • Bipolar disorder in a manic or severe depressive phase
  • Active suicidal ideation with intent or recent suicide attempt (within the past 6 months)
  • Severe cognitive impairment or neurocognitive disorders that compromise comprehension or communication or interferes with chatbot use.
  • Any condition requiring psychiatric hospitalization within the past 6 months
  • Concurrent enrollment in another trial targeting psychological distress to avoid bias.
  • Limited life expectancy (<3 months) as determined by the oncologist.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Psychotherapy + WYSA App

active comparator: Standard of Care Psychotherapy

Interventions

Standard of Care Psychotherapy

Participants will receive six psychotherapy sessions over the course of approximately 3 months.

WYSA App

Participants will have access to the WYSA mental health support artificial intelligence app over the course of the 3 months that they are participating in psychotherapy sessions per standard of care. The app will contain features intended to manage symptoms of depression and anxiety in individuals with cancer. The app will include an AI-powered chatbot with Cognitive Behavioral Therapy (CBT) and mindfulness techniques, visual progress elements (a progress roadmap, a weekly progress report, etc.), and a customizable tool library. Participants are instructed to use the app whenever they feel like it, if they are in distress, or if the app prompts them to use it. App prompts (notifications) will occur once daily.

Primary outcome measure

  • Change in Quality of Life [ Time Frame: Baseline, 3 months ]

Central Contacts and Locations

Central contacts

Zeina Nahleh, MD, FACP

954-659-5840nahlehz@ccf.org

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Zeina Nahleh, MD, FACP

954-659-5840nahlehz@ccf.org

Principal Investigator:

Zeina Nahleh, MD, FACP

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Psychotherapy
  • Mental health
  • Distress
  • Stage I Cancer
  • Stage II Cancer
  • Stage III Cancer
  • Chatbot
  • Artificial Intelligence
  • AI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-05-15.