Recruiting NCT05574127
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioral Activation, Supportive Psychotherapy.
- Who it may be relevant to
- Registry conditions: Survivorship. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Overview
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)
Interventions
- Behavioral 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). - Behavioral 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 measures
- Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups [Time frame: 2 months post intervention]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Publications
- 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 38342735
Identifiers
NCT: NCT05574127 · 22-248