Pilot Randomized Feasibility Trial of Tele-Interpersonal Psychotherapy and Tele-Pharmacotherapy for Depression in Patients With Non-Metastatic Breast Cancer

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 20 participants

Interventions

• BEHAVIORAL: Interpersonal Psychotherapy — Time-limited, affect-focused, empirically supported psychotherapy
• DRUG: Venlafaxine HCl ER — FDA-approved antidepressant medications

Primary Outcomes

• Hamilton Depression Rating Scale (Change over twelve weeks)

Secondary Outcomes

• C-Reactive Protein (Change over twelve weeks)
• Posttraumatic Stress Checklist (PCL-5) (Change over twelve weeks)
• PROMIS (Change over twelve weeks)
• Patient Health Questionnaire - 9 (PHQ-9) (Change over twelve weeks)
• Perceived Social Support Scale-Self-Report (Change over twelve weeks)

Trial Locations

• Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, United States

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