Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT05674357
Eligibility Criteria:
Patient Inclusion Criteria:
* Adults \> 18 years of age.
* Currently receiving oncology treatment/care at the MGH Cancer Center, including active treatment and/or surveillance.
* Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \> 3.
* Reports distress or presenting problem is related to patients' illness and/or treatment (e.g., cancer treatment).
* Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.
* Located in the state of Massachusetts for the duration of sessions.
Patient Exclusion Criteria:
* Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the MINI), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
* Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).
* Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.
* Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the MINI), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
Therapist Inclusion criteria:
-Current appointment as a clinical psychology fellow or psychiatry resident at the Massachusetts General Hospital or equivalent designation.
Therapist Exclusion criteria:
-Obtained licensure as a clinical psychologist in any state.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05674357
Study Brief:
Protocol Section:
NCT05674357