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Trial Title:
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
NCT ID:
NCT05574127
Condition:
Survivorship
Conditions: Official terms:
Depression
Conditions: Keywords:
Older Adult Cancer Survivors
history of cancer
22-248
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Activation
Description:
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).
Arm group label:
Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA)
Other name:
BA
Intervention type:
Behavioral
Intervention name:
Supportive Psychotherapy
Description:
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).
Arm group label:
Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP)
Other name:
SP
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)
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Saracino, PhD
Phone:
646-888-0263
Start date:
October 6, 2022
Completion date:
October 6, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05574127
http://www.mskcc.org
