Study of Web- Based Cognitive Behavioral Therapy for Depressed Korean Adolescents

Depression Clinical Trial

— wogyeokdajim  

Official title:

Study of Web-based Cognitive Behavioral Therapy in Adolescent Depression; Randomized Controlled Trial for Korean Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02072304
• Other study ID #: H-001
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: February 24, 2014
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2014
• Source: Hallym University Medical Center
• Contact: hyori jang, RN
• Phone: 10-31-381-3753
• Email: hypray85[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Ministry of Education, Science, and Technology
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develope web-based cognitive behavioral therapy for Korean adoldescents who have a mild depression. And we will investigate whether web-based cognitive behavioral therapy is more effective than supportive psychotherapy for treating depressed adolescents. Our hypothesis is web- based cognitive behavioral is more effective than supportive psychotherapy

Description:

We will recruit adolescents(age 12-18 years old) with a diagnosis of major depressive disorder, dysthymia and depressive disorder NOS in outpatient clinic of child and adolescent psychiatry and we will advertise for recruitment of subjects in community. The study protocol will be approved by the Institutional Review Board of the Hallym university sacred heart hospital. Well- trained interviewers will conduct the assessments of participants and their parents or guardians. The assessment included the diagnostic interview, demographic characteristics, depressive symptom severity scale , Columbia suicide severity rating scale, questionnaire about abuse histories.

We decided the number of participants of 164, because in previous studies, web- based cognitive behavioral therapy showed mild to moderate effect size (effect size = 0.43). So for examining the hypothesis, we will recruit 164 adolescents by calculating the number of participants using G power program version 3.1.3. (level of significance = 5%, power of a hypothesis test = 80%, drop out rate = 20%)

And we will conduct randomized controlled trial for examining the efficacy of web- based cognitive behavioral therapy. Our hypothesis is web- based cognitive behavioral is more effective than supportive psychotherapy, so we will deliver web- based cognitive behavioral therapy program to cognitive behavioral therapy group for 8 weeks(once in a week), and supportive psychotherapy to supportive psychotherapy group for 8 weeks(once in a week) We will exclude the participant if the participant has severe depressive symptoms, definite suicidal idea, plan and attempt, psychotic symptoms, bipolar disorders, sexual abuse histories, other neurological diseases or received cognitive behavioral therapy, pharmacotherapy or interpersonal psychotherapy.

We will analyze the intent- to- treat population. For each individual, missing values are replaced by the last observed value of that variable. And we will use Chi square test or repeated measure-ANOVA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of major depressive disorder, dysthymic disorder and depressive disorder NOS

• participants and their parents both agree informed consents

Exclusion Criteria:

• participants have psychotic symptoms, developmental disorders,

• participants are diagnosed by bipolar disorder

• participants are current high risk of suicide

• participants have psychiatric and physical symptoms need urgent medicine treatment

• participants have a history of sexual abuse

• participants have cognitive behavioral therapy or interpersonal psychotherapy within 3 months

• participants have a history of brain injury or a neurological disorder such as seizure disorder, or severe physical disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Depression
• Mental Disorder in Adolescence
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• web-based CBT
A cognitive behavioral program in 8 weeks that will provide participants with the following: online interactive tools to do their homeworks and guidance on using cognitive and behavioral strategies to help reduce depressive symptoms, information about the depressive symptoms and cognitive behavioral therapy
• supportive care
supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks with the following: psychoeducation about depression, stigma of mental illness, distraction technique, emotional regulation, active scheduling.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang -si	Gyeonggi-do
Korea, Republic of	Inje university ilsan paik hospital	Goyang -si	Gyeonggi-do
Korea, Republic of	National health insurance service ilsan hospital	Goyang -si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960. — View Citation

Angold A, Messer SC, Stangl D, Farmer EM, Costello EJ, Burns BJ. Perceived parental burden and service use for child and adolescent psychiatric disorders. Am J Public Health. 1998 Jan;88(1):75-80. — View Citation

Birmaher B, Brent D; AACAP Work Group on Quality Issues, Bernet W, Bukstein O, Walter H, Benson RS, Chrisman A, Farchione T, Greenhill L, Hamilton J, Keable H, Kinlan J, Schoettle U, Stock S, Ptakowski KK, Medicus J. Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 2007 Nov;46(11):1503-26. — View Citation

Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996 Nov;35(11):1427-39. Review. — View Citation

Bostwick JM, Pankratz VS. Affective disorders and suicide risk: a reexamination. Am J Psychiatry. 2000 Dec;157(12):1925-32. — View Citation

Brent DA, Perper JA, Goldstein CE, Kolko DJ, Allan MJ, Allman CJ, Zelenak JP. Risk factors for adolescent suicide. A comparison of adolescent suicide victims with suicidal inpatients. Arch Gen Psychiatry. 1988 Jun;45(6):581-8. — View Citation

Calear AL, Christensen H, Mackinnon A, Griffiths KM, O'Kearney R. The YouthMood Project: a cluster randomized controlled trial of an online cognitive behavioral program with adolescents. J Consult Clin Psychol. 2009 Dec;77(6):1021-32. doi: 10.1037/a0017391. — View Citation

March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. — View Citation

Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. — View Citation

Van Voorhees BW, Fogel J, Reinecke MA, Gladstone T, Stuart S, Gollan J, Bradford N, Domanico R, Fagan B, Ross R, Larson J, Watson N, Paunesku D, Melkonian S, Kuwabara S, Holper T, Shank N, Saner D, Butler A, Chandler A, Louie T, Weinstein C, Collins S, Baldwin M, Wassel A, Vanderplough-Booth K, Humensky J, Bell C. Randomized clinical trial of an Internet-based depression prevention program for adolescents (Project CATCH-IT) in primary care: 12-week outcomes. J Dev Behav Pediatr. 2009 Feb;30(1):23-37. doi: 10.1097/DBP.0b013e3181966c2a. — View Citation

Van Voorhees BW, Vanderplough-Booth K, Fogel J, Gladstone T, Bell C, Stuart S, Gollan J, Bradford N, Domanico R, Fagan B, Ross R, Larson J, Watson N, Paunesku D, Melkonian S, Kuwabara S, Holper T, Shank N, Saner D, Butler A, Chandler A, Louie T, Weinstein C, Collins S, Baldwin M, Wassel A, Reinecke MA. Integrative internet-based depression prevention for adolescents: a randomized clinical trial in primary care for vulnerability and protective factors. J Can Acad Child Adolesc Psychiatry. 2008 Nov;17(4):184-96. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Center for Epidemiological Studies of Depression (CES-D) Scale	Change in CESD from baseline Change in CESD scale between and within groups across the 8 weeks and for each assessment point	0, 4, 8 weeks	Yes
Primary	Subjective depressed mood scale	Change in Subjective depressed mood scale from baseline Change in Subjective depressed mood scale scale within web CBT groups across the 8 week	each week during 8 weeks	Yes
Primary	The Korean youth self report (K-YSR)	Change in K-YSR from baseline Change in K-YSR scale between and within groups across the 8 weeks	0, 8 weeks	Yes
Secondary	Acceptability and adherence of Web-based cognitive behavioral treatment program for adolescents with depression	After treatment, we will check out how many the participants complete the session.	8 weeks	No
Secondary	satisfaction of Web-based cognitive behavioral treatment program of both adolescents with depression and their parents	After treatment, we will check out how the participants and their parent feel satisfaction about treatment	8 week	No
Secondary	Columbia suicide severity rating scale	Change in CSSRS from baseline Change in CSSRS scale between and within groups across the 8 weeks and for each assessment point	0, 4 8 weeks after baseline assessment	Yes
Secondary	Adolescent's characteristics that moderate the impact of the program	we will find out adolescent's characteristics that moderate the impact of the program	0, 4 and 8 weeks after baseline assessment	No