NCT05674357 Training in Evidence-based Treatments in Psycho-Oncology
| NCT ID | NCT05674357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Distress, Emotional |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2023-01-09 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 115 participants in total. It began in 2023-01-09 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress. The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem. * Cognitive Behavioral Therapy (CBT) * Acceptance Commitment Therapy (ACT) * Mindfulness-Based Cognitive Therapy (MBCT) * Mindfulness-Based Stress Reduction (MBSR) * Meaning-Centered Psychotherapy (MCP) * Cognitive Behavioral Therapy for Insomnia (CBT-I) * CBT for other cancer-related physical symptoms like pain, fatigue, and nausea. Participation in this research study is expected to last about 26 weeks. It is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.
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. Caregiver Inclusion criteria: * Adults \> 18 years of age * Currently caring for someone 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 caregiving * Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for caregiving-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 QuickSCID-5), 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 QuickSCID-5), 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.
Contact & Investigator
Jamie Jacobs, Ph.D
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05674357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distress, Emotional. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05674357 currently recruiting?
Yes, NCT05674357 is actively recruiting participants. Contact the research team at jjacobs@mgh.harvard.edu for enrollment information.
Where is the NCT05674357 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05674357 clinical trial?
NCT05674357 is sponsored by Massachusetts General Hospital. The principal investigator is Jamie Jacobs, Ph.D at Massachusetts General Hospital. The trial plans to enroll 115 participants.