- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02232438
Psychotherapy for Depressed or Anxious Adolescents With Cancer
Open Trial of Behavioral Activation Therapy for Depressed or Anxious Adolescents With Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Multidimensional Anxiety Scale for Children (MASC 2)
Time Frame: baseline, and every two weeks till week 10
|
10 to 15 minutes of mood assessment.
|
baseline, and every two weeks till week 10
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6797
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Behavioral activation therapy
-
New York State Psychiatric InstituteCallen-Lorde Community Health CenterCompletedHIV Infection | FatigueUnited States
-
Seinajoki Central HospitalTampere UniversityCompletedAnxiety Disorders | Major Depression | Dual Diagnosis | Substance Related DisordersFinland
-
Universidad Autonoma de Baja CaliforniaUniversidad Autonoma de Ciudad Juarez; Universidad Nacional Autonoma de MexicoUnknownDepression, AnxietyMexico
-
Uppsala UniversityCompletedDepressive Symptoms | Inpatient Facility Diagnoses | Psychiatric Disorders
-
VA Office of Research and DevelopmentCompletedObsessive Compulsive Disorder | Generalized Anxiety Disorder | Major Depressive Disorder | Posttraumatic Stress Disorder | Panic Disorder | Social Phobia | Specific Phobia | Persistent Depressive DisorderUnited States
-
Rutgers UniversityThe Klingenstein Third Generation FoundationCompletedDepressive Disorder | Anxiety DisordersUnited States
-
Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH)RecruitingDepression | AnxietyUnited States
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)CompletedSubstance Use DisorderUnited States
-
M.D. Anderson Cancer CenterRecruitingDepression | Tobacco Use DisorderUnited States
-
Research Foundation for Mental Hygiene, Inc.Completed