A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
August 25, 2026 updated by: Memorial Sloan Kettering Cancer Center
Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca Saracino, PhD
- Phone Number: 646-888-0263
- Email: jamesr@mskcc.org
Study Contact Backup
- Name: Christian Nelson, PhD
- Phone Number: 646-888-0030
- Email: nelsonc@MSKCC.ORG
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All protocol activities)
-
Contact:
- Rebecca Saracino, PhD
- Phone Number: 646-888-0263
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Study Population
Potential participants will be identified by the MSK study investigators, the patient's treating clinician, or review of the MSK Survivorship clinic lists.
Since we plan to recruit all patients 65years of age or older, regardless of type of cancer, we will also identify potential patients by query of MSK institutional databases (e.g., DaVinci, Dataline).
Once the list is created, members of the protocol research team will verify the medical eligibility against the patient's medical record prior to contacting the patient regarding participation.
Description
Inclusion Criteria:
Phase I:
- As per self-report or medical record, ≥65 years old
- As per self-report or medical record, has a history of cancer
As per medical record and/or clinician confirmation:
- a patient in MSK Survivorship Clinics AND/OR
- no evidence of disease (NED) AND/OR
- 6 months or more post-treatment (patients on maintenance hormonal therapies are eligible)
- Fluent in English, as per self-reported fluency of "well" or "very well"*
- As per self-report, able to communicate over video-conference and/or phone for sessions
- Elevated score on the PHQ-9: ≥5 (N/A for Training Case participants)
- Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)
Phase II:
- As per self-report or medical record, ≥18 years old
- Fluent in English, as per self-reported fluency of "well" or "very well"*
- As per self-report or medical record, has a history of cancer
- Elevated score on the PHQ-9: ≥5
- Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)
Note. The eligibility criteria for Phase II allows inclusion of younger participants and those receiving active treatment due to the theoretical rationale that a single-session intervention will remove certain barriers that are believed to exist for these groups in receiving the longer, 10-session intervention.
Exclusion Criteria:
Phase I:
- As per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of > 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
- As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
- As per self-report or medical record, currently taking antidepressant medication for < 3 month
- As per medical record, patient has impaired decision-making capacity
Phase II:
- As per PI determination, requires a higher level of care for current active suicidal ideation than current protocol is able to provide. If a participant receives a score of > 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
- As per self-report or medical record, current weekly psychotherapy or currently taking an antidepressant for <3 months.
As per medical record, patient has impaired decision-making capacity
Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:
- How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- What is your preferred language for healthcare? (must respond English)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase I: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)
Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention
|
Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:
Other Names:
|
|
Experimental: Phase I: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)
Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention
|
Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:
Other Names:
|
|
Experimental: Phase II: Ultra-brief Behavioral Activation for Oncology (UBA-O)
UBA-O involves a single 90-minute video-conference session that includes all of the core elements of Brief BA (BBA)
|
Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:
Other Names:
|
|
Active Comparator: Phase II: Supportive Psychotherapy (SP) Control Arm
Supportive Psychotherapy/SP will involve a single session (60-90 minutes), over the telephone and/or video-conference (per patient preference)
|
Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups
Time Frame: 2 months post intervention
|
Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 consists of nine items, each of which corresponds to one of the nine symptoms required for a diagnosis of a major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders.
Respondents are asked to rate how often they have been bothered by each of the nine symptoms over the preceding two weeks.
Respondents rate each item on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day).
Its reliability and validity have been established in diverse general and medical populations.
Total scores range from 0-27; In outpatient cancer settings, psychometric research suggests that a score of ≥8 indicates clinically significant depressive symptoms and should be used as a clinical cut-off .
|
2 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rebecca Saracino, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
October 6, 2022
First Submitted That Met QC Criteria
October 6, 2022
First Posted (Actual)
October 10, 2022
Study Record Updates
Last Update Posted (Actual)
August 27, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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