Recruiting

Behavioral Activation

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05574127

Conditions

Survivorship

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Behavioral Activation

Supportive Psychotherapy

Study Details

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)

Conditions

Survivorship

Study ID

NCT05574127

Start date

Oct 6, 2022

Status verified date

Aug, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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:

1. 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)
2. What is your preferred language for healthcare? (must respond English)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)

Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention

experimental: Phase I: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)

Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention

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)

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)

Interventions

Behavioral Activation

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).

Supportive Psychotherapy

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).

Primary outcome measure

  • Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups [ Time Frame: 2 months post intervention ]

Central Contacts and Locations

Central contacts

Rebecca Saracino, PhD

646-888-0263jamesr@mskcc.org

Christian Nelson, PhD

646-888-0030nelsonc@MSKCC.ORG

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Rebecca Saracino, PhD

646-888-0263

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Older Adult Cancer Survivors
  • history of cancer
  • 22-248
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-27.