Clinical trial · Interventional
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
NCT05574127CI-TRIAL-00124123recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Activation | Behavioral | — | UNRESOLVED |
| Supportive Psychotherapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase I: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)
- description
- Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention
- interventionNames
- Behavioral: Behavioral Activation
- type
- EXPERIMENTAL
- label
- Phase I: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)
- description
- Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention
- interventionNames
- Behavioral: Supportive Psychotherapy
- type
- EXPERIMENTAL
- label
- Phase II: Ultra-brief Behavioral Activation for Oncology (UBA-O)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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)References
Publications (1)
- DERIVEDSaracino 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 38342735