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

ConditionSurvivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

As per self-report or medical record, ≥65 years old

As per self-report or medical record, has a history of cancer

a patient in MSK Survivorship Clinics AND/OR

no evidence of disease (NED) AND/OR

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Behavioral Activation

    Behavioral

    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).

  • Supportive Psychotherapy

    Behavioral

    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).

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: Phase I: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)Experimental treatment 1 intervention
Group B: Phase I: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)Experimental treatment 1 intervention
Group C: Phase II: Ultra-brief Behavioral Activation for Oncology (UBA-O)Experimental treatment 1 intervention
Group D: Phase II: Supportive Psychotherapy (SP) Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups

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 .

Time frame
2 months post intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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