Psychotherapy for Depressed or Anxious Adolescents With Cancer

Study Overview
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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.

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

Conditions
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Anxiety, Cancer, Depression

Intervention / Treatment
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* Behavioral: Behavioral activation therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral activation therapy<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Multidimensional Anxiety Scale for Children (MASC 2) | 10 to 15 minutes of mood assessment. | baseline, and every two weeks till week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Depression, Psychotherapy, Anxiety