Psychotherapy for Depressed or Anxious Adolescents With Cancer

NCT02232438 | Withdrawn DMC

• 1 other identifier: 6797
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Cancer

Keywords

Depression; Psychotherapy; Anxiety; Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Multidimensional Anxiety Scale for Children (MASC 2)

  10 to 15 minutes of mood assessment.

  baseline, and every two weeks till week 10

Study Arms (1)

Behavioral activation therapy

EXPERIMENTAL

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.

Behavioral: Behavioral activation therapy

Interventions

Behavioral activation therapy BEHAVIORAL

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).

Behavioral activation therapy

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 5, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (1)