Psychotherapy for Depressed or Anxious Adolescents With Cancer

Not Applicable

Withdrawn

• Conditions: Depression; Anxiety; Cancer
• Interventions: Behavioral: Behavioral activation therapy

• Registration Number: NCT02232438
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

At present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. Fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.

Detailed Description

Despite the high prevalence of depression and anxiety in cancer patients, little is known about the efficacy of psychotherapy in depressed and anxious adolescents with cancer.

Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients, including adult cancer patients. The goal of this open label clinical trial is to obtain preliminary evidence of the efficacy of BAT(6 sessions) in a group of adolescent cancer patients with MDD, GAD or adjustment disorder with mood or anxiety features.

We will test the efficacy of BAT using the Multidimensional Anxiety Scale for Children at several time points of the treatment.

Study Timeline

• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-05
• Study Start: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• A primary psychiatric diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder or Adjustment Disorder with Mood or Anxiety features as defined by DSM-IV.
• Cancer patients.
• Parent consent and child assent to participate for patients younger than 18. Patient consent for subjects 18-21.
• Diagnosis of cancer (stage 1-4), but healthy enough to complete study procedures.

Exclusion Criteria

• Lifetime history of psychosis or bipolar disorder.
• Current suicide risk.
• History of substance abuse or dependence in the three months prior to the study.
• Patients who have ever failed BAT in the context of cancer.
• Receiving other concurrent therapy for same disorder and patients who are receiving effective medication for depression.
• Mental retardation.
• CNS tumors.
• Patients undergoing Stem Cell Transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral activation therapy	Behavioral activation therapy	Patients treated with Behavioral activation therapy will improve in mood and anxiety symptoms and psychosocial functioning at the end of the 6 weeks of treatment.

Primary Outcome Measures

Name	Time	Method
Change in Multidimensional Anxiety Scale for Children (MASC 2)	baseline, and every two weeks till week 10	10 to 15 minutes of mood assessment.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States