Clinical Trials Logo

Clinical Trial Summary

The investigators propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder (MDD).


Clinical Trial Description

Depressive symptoms and disorders are common in cancer patients: up to 58% have depressive symptoms, and 38% meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for major depressive disorder (MDD). Depression worsens over the course of cancer treatment, persists long after cancer therapy, recurs with recurrence of cancer, and negatively affects patients' adherence to cancer treatment, survival, symptom management, psychosocial functioning, and quality of life. As surviving cancer becomes increasingly common, there is an urgent need to establish an empirical basis for the provision of evidence-based treatments to depressed cancer patients.We propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder. The study is based on several complementary observations from recent studies. First, 30-60% of cancer patients experience clinically significant depressive symptoms. Second, depression is associated with poorer cancer outcomes. Third, over the course of the illness, depression recurs or persists for a significant number of cancer patients. Fourth, several recent reviews have indicated that, despite decades of research and hundreds of studies, the available evidence is insufficient to empirically guide the treatment of major depressive disorder in cancer patients. This has led the national institute of health, the Institute of Medicine, and other experts to call for well-designed, controlled trials of the treatment of depression in cancer patients.

Interpersonal Psychotherapy is a brief, manualized therapy that has shown efficacy in treating major depression in several controlled trials including a large trial for depressed HIV-infected individuals and other randomized trials in depressed individuals with other comorbid medical illnesses. Research shows that Interpersonal Psychotherapy improves social skills and functioning. Interpersonal Psychotherapy has shown remarkable flexibility and efficacy across age ranges, cultures, formats, and modes of delivery. We recently obtained promising pilot data in a small open trial on the acceptability and efficacy of individual Interpersonal Psychotherapy for depressed breast cancer patients of diverse ethnic background, socioeconomic status, and cancer progression stage. Problem-Solving Therapy is a brief, manualized form of cognitive-behavioral therapy (CBT) that has been adapted to treat depression in cancer patients, and has shown highly promising results. Brief Supportive Psychotherapy, a relatively unstructured psychotherapy commonly used in clinical practice, focuses on the patient's affect. It builds a strong therapeutic alliance through careful, empathic listening and validating and encouraging toleration of the patient's emotions. It has shown promising results in depressed individuals with cancer and other medical illnesses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01191580
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 4
Start date October 2009
Completion date June 2017

See also
  Status Clinical Trial Phase
Completed NCT03062150 - Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression N/A
Completed NCT04352101 - Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits Phase 4
Completed NCT02855918 - Blood Biomarkers in Suicidal Behaviour N/A
Recruiting NCT03039387 - Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients N/A
Recruiting NCT02213016 - Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients Phase 4
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Recruiting NCT02237937 - Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene Phase 4
Completed NCT01201148 - Open Pilot Trial of TES for Depression Phase 2
Completed NCT00953108 - Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients Phase 3
Completed NCT00806143 - Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression Phase 4
Terminated NCT00695552 - The Effect of Exercise on Depressive Symptoms in Unmedicated Patients N/A
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Completed NCT00466323 - The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness. N/A
Completed NCT00532480 - Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine Phase 4
Completed NCT00482482 - Yoga in Unipolar and Bipolar Disorders N/A
Completed NCT00616759 - The Effect on Cognition of Terminating ECT Induced Seizures With Propofol N/A
Recruiting NCT00209807 - Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder Phase 4
Completed NCT00167310 - Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation Phase 2