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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Survivorship

Treatments: Behavioral: Supportive Psychotherapy; Behavioral: Behavioral Activation

Study type: Interventional

Funder types: Other

Identifiers

NCT05574127

22-248

Details and patient eligibility

About

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)

Enrollment: 90 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral Activation

Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)

Experimental group

Description:

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

Treatment:

Behavioral: Supportive Psychotherapy