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WithdrawnNCT02232438Updated Oct 7, 2015

Psychotherapy for Depressed or Anxious Adolescents With Cancer

An interventional study of Behavioral activation therapy in Depression, Anxiety and Cancer, sponsored by New York State Psychiatric Institute. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2015-10-07.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
12 Years to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression
  • Anxiety
  • Cancer

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Keywords

  • Depression
  • Psychotherapy
  • Anxiety
  • Cancer
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Behavioral activation therapy

Interventions

  • BehavioralBehavioral 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).

06

What researchers measure

Primary outcomes

  1. Change in Multidimensional Anxiety Scale for Children (MASC 2)

    10 to 15 minutes of mood assessment.

    Time frame: baseline, and every two weeks till week 10

07

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02232438
Lead sponsor
New York State Psychiatric Institute
Responsible party
Sponsor
First posted
Sep 5, 2014
Start date
Jan 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Oct 7, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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