Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metas… (NCT04973930) | Clinical Trial Compass
SuspendedPhase 3
Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer
Stopped: NYSPI paused human subjects research (HSR) 6/23. The US Dept. of Health and Human Services Office of Human Research Protections issued an FWA restriction pausing such research 6/23/23. The IO and IRB paused HSR 6/12/23. Hence no current enrolling.
United States20 participantsStarted 2022-03-01
Plain-language summary
Cancer and depression commonly occur together, and each worsens the other. We conducted a large psychotherapy study treating depression in breast cancer patients, showing that psychotherapy lowers symptoms. Surprisingly, no studies have compared depression-focused psychotherapy to antidepressant medication for patients with breast cancer and depression. We applied to the National Cancer Institute for a large, cross-national grant. Reviewers asked us to first demonstrate that patients would accept either psychotherapy or medication as treatment.
Thanks to funding from the Columbia Herbert Irving Cancer Center, we will test this study approach. We will randomly assign 20 patients with both non-metastatic breast cancer and major depression to 12 weeks of tele-therapy (by Zoom) with either interpersonal psychotherapy or a serotonin reuptake inhibitor. We expect patients in both treatments to report improvement in depression symptoms. We will also measure C-reactive protein, a blood test of inflammation elevated in both cancer and depression, which may predict medication response.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosis of diagnosis of Stage I-III breast cancer (\<10 years from diagnosis)
* episode of major depressive disorder without psychotic features on Structured Clinical Interview for DSM-5 (SCID-5)
* 24-item Hamilton Depression Rating Scale score ≥18
* written informed consent
Exclusion Criteria:
* Psychosis (by SCID-5 interview)
* current moderate/severe substance use disorder (mild substance disorder is not an exclusion)
* acute suicidal risk
* history of non-response to (\>6 week) trials of venlafaxine (≥225 mg/d) and escitalopram (≥20 mg/d);
* history of non-response to IPT (\>4 sessions
* receiving current medication or psychotherapy treatment for depression
* acute medical instability (too physically debilitated to participate in trial) or delirium
* inability to complete self-administered questionnaires in English
* current enrollment in a therapeutic oncology trial
* known metastases
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.