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

Survivorship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574127
• Other study ID #: 22-248
• Status: Recruiting
• Phase: Phase 2
• Start date: October 6, 2022
• Est. completion date: October 6, 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Rebecca Saracino, PhD
• Phone: 646-888-0263
• Email: jamesr[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 6, 2024
• Est. primary completion date: October 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Survivorship

Intervention

Behavioral:
• Behavioral Activation
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
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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	2 months post intervention

External Links

•   Memorial Sloan Kettering Cancer Center