Clinical trial · Interventional
Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer
Pilot Randomized Feasibility Trial of Tele-Interpersonal Psychotherapy and Tele-Pharmacotherapy for Depression in Patients With Non-Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Major Depressive Disorder | — | UNRESOLVED | — |
| Venlafaxine | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interpersonal Psychotherapy | Behavioral | — | UNRESOLVED |
| Venlafaxine HCl ER | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tele-Interpersonal Psychotherapy (IPT)
- description
- Interpersonal psychotherapy is a time-limited, affect-focused treatment of repeatedly demonstrated efficacy for major depression in the general population. It was also helpful to patients with comorbid depression and breast cancer in our prior randomized controlled trial. IPT focuses on the connection between upsetting life circumstances (e.g., diagnosis of breast cancer) and their effect on mood, and vice versa. We have considerable experience, enhanced by the Covid-19 lockdown, in delivering IPT as a HIPAA-secure tele-therapy.
- interventionNames
- Behavioral: Interpersonal Psychotherapy
- type
- ACTIVE_COMPARATOR
- label
- Tele-Serotonin Reuptake Inhibitor
- description
- Both venlafaxine and escitalopram are FDA-approved treatments with demonstrated efficacy in treating major depression in the general population. Although little formal research has been done in treating patients with depression and breast cancer, these two are the favored treatments among serotonin reuptake inhibitors due to minimal interference with oncotherapy. The choice between prescribing these two study medications will depend upon prior treatment history. Venlafaxine XR will be serially titrated under expert psychopharmacologist tele-guidance from 75 mg to 300 mg daily, depending on clinical response and tolerance. Escitalopram will similarly be dosed between 5 mg and 30 mg daily.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDWeissmann MM, Markowitz JC, Klerman GL: The Guide to Interpersonal Psychotherapy. New York, Oxford University Press, 2018. ISBN-13: 978-0190662592
- RESULTBlanco C, Markowitz JC, Hellerstein DJ, Nezu AM, Wall M, Olfson M, Chen Y, Levenson J, Onishi M, Varona C, Okuda M, Hershman DL. A randomized trial of interpersonal psychotherapy, problem solving therapy, and supportive therapy for major depressive disorder in women with breast cancer. Breast Cancer Res Treat. 2019 Jan;173(2):353-364. doi: 10.1007/s10549-018-4994-5. Epub 2018 Oct 20. PMID 30343455
- RESULTBlanco C, Markowitz JC, Hershman DL, Levenson JA, Wang S, Grann VR. A Pilot Study of Interpersonal Psychotherapy for Depressed Women with Breast Cancer. Am J Psychother. 2014;68(4):489-95. doi: 10.1176/appi.psychotherapy.2014.68.4.489. PMID 26453348
- RESULTMarkowitz JC, Hellerstein DJ, Falabella G, Lan M, Levenson J, Crew KD, Hershman DL. Psychopharmaphobia: Elevated fear of antidepressant medication among patients with major depression and breast cancer. Gen Hosp Psychiatry. 2023 Jul-Aug;83:117-122. doi: 10.1016/j.genhosppsych.2023.05.005. Epub 2023 May 6. No abstract available. PMID 37172545