Psychotherapy for Depressed or Anxious Adolescents With Cancer

Depression Clinical Trial

Official title:

Open Trial of Behavioral Activation Therapy for Depressed or Anxious Adolescents With Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02232438
• Other study ID #: 6797
• Status: Withdrawn
• Phase: N/A
• First received: September 2, 2014
• Last updated: October 5, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2015
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Cancer
• Depression

Intervention

Behavioral:
• Behavioral activation therapy
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 (see review in Dimidjan et al., Ann Rev Clin Psychol, 2010, and Chu, Brian C., et al. Cognitive and Behavioral Practice, 2009.), including adult cancer patients (Hopkoet al., 2009; Hopko et al., 2011).

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Multidimensional Anxiety Scale for Children (MASC 2)	10 to 15 minutes of mood assessment.	baseline, and every two weeks till week 10	No