Major Depressive Disorder Clinical Trial
— iTADOfficial title:
Information Technology Enabled Treatment of Adolescent Depression
Verified date | April 2015 |
Source | iHope Network, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate a computer-guided, telephone-based therapy for adolescent depression, delivered in a pediatric primary setting in the community.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Major Depressive Disorder - Age 12-17 years, inclusive, at time of first study visit - Ability to receive care as an outpatient - Ability to participate in at least 1 session by phone per week for approximately 12 weeks - Ability to participate in at least 1 session by phone per week for approximately 12-16 weeks - Ability to speak English fluently and to provide written and/or verbal feedback on the instrument and the process. - Pediatrician impression of normal IQ for developmental level Exclusion Criteria: - Current or past diagnosis of: bipolar disorder, severe conduct disorder, pervasive developmental disorders, of thought disorder - Current treatment with Cognitive Behavioral Therapy (CBT) - Confounding medical condition (such as pregnancy, Lyme disease, etc.) - Non-English speaking patient or parent/guardian - No access to phones - Dangerousness to self or others if they have been hospitalized for dangerousness within three months of consent - Deemed to be "high risk" because of a suicide attempt requiring medical attention within 6 months of consent or clear intent or an active plan to commit suicide - History of self-harm, suicidal attempts, or suicidal ideation - Specialty care for substance abuse (i.e. without participation of primary care providers) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Connecticut Health Center | Farmington | Connecticut |
United States | Woburn Pediatric Associates | Woburn | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
iHope Network, Inc. | University of Connecticut Health Center, Woburn Pediatric Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in measures of depression over the course of treatment among teens with Major Depressive Disorder. | The measure used is the PHQ-9 (Kroenke, et al.), a standard and validated measure for use in screening for or monitoring adolescent depression. Teens that score positively on Item #9 (a self-harm risk item), will be further evaluated by the clinician using two interactive and validated methods for standardized assessment of suicide risk: a brief version of the Beck Hopelessness scale and the C-CASA (Columbia University). Teens needing referral to a behavioral health specialist will be referred by the nurse and/or the pediatrician for further evaluation and treatment. | 12 weeks | Yes |
Secondary | Evidence of program efficacy as indicate by changes in subjects' knowledge of depression. | A Depression Knowledge Test (DKT) will be used to assess changes in the level of knowledge teens have about depression and its treatment. The DKT consists of 10 open response questions based on materials from the TADS Adolescent Workbook. Sample questions include "We know there are four main causes of depression. List as many as you can," and "There are some learned patterns that people need to change to overcome depression. List as many patterns as you can." | 12 weeks | No |
Secondary | Evidence of program efficacy as indicated by development of self-efficacy skills. | A Skill Self-Efficacy Questionnaire (SSEQ) will be used to assess changes in the level of self-confidence teens have in their ability to use the cognitive behavioral skills taught in the demo program. Using the same assessment schedule as the DKT, teens will be asked to rate self-confidence in their ability to "set goals," "achieve goals," "know what they are feeling," "know how intensely they feel something," and "know what causes their feelings." | 12 weeks | No |
Secondary | Evidence of program efficacy as indicated by the establishment of therapeutic alliance. | Therapeutic alliance between adolescents and nurse managers will be measured by the Therapeutic Alliance Scale for Adolescents (TASA; Shrink et al., 2008. The TASA is explicitly designed to measure the strength of the therapeutic alliance among teens participating in CBT treatments. A maximum score is 6.0 based on a Likert scale from one to six. The list of items for this measure of therapeutic alliance indicates very high bonding between counselors and patients. | 12weeks | No |
Secondary | Evidence of program efficacy as indicated by fidelity and treatment quality. | The Cognitive Therapy Scale (CTR) will be used as a measure of treatment quality and fidelity of the calls by and interactions of the study nurses with the teens. The CTR has been considered a standard measure of competence in cognitive therapy for more than 20 years,(Young JE 1980; Dobson, Shaw et al. 1985; Vallis, Shaw et al. 1986). Recorded sessions will be rated on the scale by certified raters from the American Academy of Cognitive Therapy (ACT). | 12 weeks | No |
Secondary | Evidence of program efficacy as indicated by program acceptance. | An acceptance questionnaire will be administered to teens to determine their overall perception and acceptance of the program. The questionnaire contains 9 questions, asking the subject to rate the usefulness of the program; comment on its quality, and suggest areas for improvement. The acceptance questionnaire uses a 7-point Likert scale for rating purposes ranging from (1 = not at all to 7 = extremely). It also includes three open-ended questions to capture what teens like the best or the least about the program, and their suggestions for improving the program. | 12 weeks | No |
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