A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
1 other identifier
interventional
150
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2022
CompletedStudy Start
First participant enrolled
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 27, 2026
August 1, 2026
4.7 years
October 6, 2022
August 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups
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
Study Arms (4)
Phase I: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)
EXPERIMENTALOlder adult cancer survivors (OACS) will receive a Behavioral Activation intervention
Phase I: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)
EXPERIMENTALOlder adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention
Phase II: Ultra-brief Behavioral Activation for Oncology (UBA-O)
EXPERIMENTALUBA-O involves a single 90-minute video-conference session that includes all of the core elements of Brief BA (BBA)
Phase II: Supportive Psychotherapy (SP) Control Arm
ACTIVE COMPARATORSupportive Psychotherapy/SP will involve a single session (60-90 minutes), over the telephone and/or video-conference (per patient preference)
Interventions
Sessions for both arms (BP \& SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline: * Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks). * Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).
Sessions for both arms (BP \& SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline: * Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks). * Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).
Eligibility Criteria
You may qualify if:
- 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
- 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
- +2 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Publications (1)
Saracino RM, Park EY, Demirjian C, Jutagir DR, McConnell KM, Schofield E, Raue PJ, Lejuez CW, Nelson CJ. Protocol for a randomized controlled trial of brief behavioral activation among older adult cancer survivors. J Geriatr Oncol. 2024 Jun;15(5):101719. doi: 10.1016/j.jgo.2024.101719. Epub 2024 Feb 10.
PMID: 38342735DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Saracino, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 10, 2022
Study Start
October 6, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
August 27, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
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.