Clinical trial NCT05674357: Training in Evidence-based Treatments in Psycho-Oncology
Official title: Training in Evidence-based Treatments in Psycho-Oncology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distress, Emotional
Depression, Anxiety
Fatigue
Pain
Insomnia
Keywords: CBT
Cognitive-Behavioral Therapies
Emotional Distress
Anxiety
Depression
Symptom-Related Distress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups in this study- one is patient participants (n=100) and the other is therapist participants (n=15). Therapist participants will deliver evidence-based therapy treatments to patients participants. Outcomes in each group will not be compared to each other.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress due to their illness and/or treatment.

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 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 100 people and 15 therapists will take part in this research study.

Detailed description: This is a single-arm, behavioral intervention study to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress related to their illness and/or treatment. For participants with cancer, common treatment goals include improving health behaviors, reducing psychological symptoms that may exacerbate medical disability, and/or improving functional status.

Research procedures include screening for eligibility, completion of surveys and questionnaires, and virtual or in-person therapy sessions.

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 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 100 people and 15 therapists will take part in this research study.

Patient participants will be those who a) are currently receiving oncology care, including active treatment and/or surveillance, b) report elevated levels of distress (≥ 3 on the NCCN Distress Thermometer), c) report that their distress or presenting concerns are related to their illness and/or their treatment(s), and d) have a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for cancer-related distress per the therapist and the supervising therapist's discretion. The investigators aim to recruit up to 100 patient participants to this study over the course of 5 years. Therapist participants will be fellows or residents in the Mass General's Center for Psychiatric Oncology \& Behavioral Sciences. The investigators aim to include up to 15 therapist participants over the course of this 5-year study. The study period for therapist participation would be up to 3 years, and would end either at a) 3 years, b) the point at which the therapist obtains licensure and transitions to faculty member, c) the time the therapist leaves MGH.

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.

Primary outcomes:
measure: Evidence-Based Treatment Acceptability
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Coping Self-Efficacy
timeFrame: up to 26 weeks
measure: Quality of Life (FACT-G)
timeFrame: up to 26 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jamie Jacobs, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: