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Recruiting NCT05574127

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

Conditions: Survivorship

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 150
Sponsor: Memorial Sloan Kettering Cancer Center

Location: Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

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)

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05574127). StuddyBuddy aggregates publicly available trial information.