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Clinical Trials/NCT05574127
NCT05574127
Active, Not Recruiting
Phase 2

Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

Memorial Sloan Kettering Cancer Center1 site in 1 country86 target enrollmentOctober 6, 2022
ConditionsSurvivorship

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Survivorship
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
86
Locations
1
Primary Endpoint
Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups
Status
Active, Not Recruiting
Last Updated
6 months ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
October 6, 2022
End Date
June 1, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 .

Study Sites (1)

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