Psychotherapy for Depressed or Anxious Adolescents With Cancer

NCT ID: NCT02232438

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Depression Anxiety Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral activation therapy

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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6797

Identifier Type: -

Identifier Source: org_study_id

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