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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

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: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 4 patient groups

Phase I: 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

Phase I: 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

Phase II: Ultra-brief Behavioral Activation for Oncology (UBA-O)

Experimental group

Description:

UBA-O involves a single 90-minute video-conference session that includes all of the core elements of Brief BA (BBA)

Treatment:

Behavioral: Behavioral Activation

Phase II: Supportive Psychotherapy (SP) Control Arm

Active Comparator group

Description:

Supportive Psychotherapy/SP will involve a single session (60-90 minutes), over the telephone and/or video-conference (per patient preference)

Treatment:

Behavioral: Supportive Psychotherapy