Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Columbia University
• Treatments: Citalopram; Venlafaxine Hydrochloride

Criteria

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