Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
NCT ID: NCT06368557
Last Updated: 2024-04-16
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
RECRUITING
Clinical Phase
NA
Total Enrollment
168 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-10
Study Completion Date
2025-06-30
Brief Summary
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The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the
Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:
1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
2. What effect different degrees of therapist support have on the treatment.
Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.
Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment.
Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:
1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
2. What effect different degrees of therapist support have on the treatment.
Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.
Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment.
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Detailed Description
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Introduction
Among children and adolescents the most prevalent mental health conditions are anxiety disorders, with around 5-12% of youth in western countries fulfilling the criteria for an anxiety diagnosis. Evidence points to an increase in the prevalence of anxiety disorders during the transition from childhood to adolescence and from adolescence to adulthood up to age 30. Untreated anxiety disorders tend to chronify or become recurrent in the developmental course and persist into adulthood.
Cognitive behavioral therapy (CBT), in both individual and group format, is effective in treating young people with anxiety. Despite the existence of effective treatment options and the possible long-term consequences associated with untreated anxiety disorders in youth, it is estimated that less than 25% of children and adolescents with anxiety disorders receive professional help, with fewer receiving evidence-based treatment. Frequently mentioned barriers for adolescents opting to seek treatment include social stigma, shyness and fear of peer rejection, preference for self-reliance, confidentiality, privacy and anonymity concerns, worries concerning treatment costs, transportation or waiting times and limited availability of psychological treatment. Thus, it is of the utmost importance to consider these barriers when developing interventions to overcome these and thus increase treatment accessibility.
Internet-based cognitive behavioral therapy (iCBT) may be an effective alternative to face-to-face treatment, that can address some of the aforementioned barriers to treatment by providing greater flexibility, greater autonomy, reduced expenses, and eliminate travel time. To date, fourteen randomized controlled trials (RCTs) have evaluated iCBT programs in both children and adolescents with anxiety disorders. Four of these included predominantly or only adolescents and showed promising results with between group effect sizes ranging from d = 0.65-1.04 at follow-up.
Objectives
The primary aim of the present study is to examine the efficacy of an internet-delivered cognitive behavioral therapy intervention, CoolMinds, in adolescents aged 12-17 years, when delivered with planned feedback or on-demand feedback from a therapist compared to a waitlist control. Additionally, the study will explore the efficacy of delivering one booster session compared to none. It is hypothesized that:
1. CoolMinds will lead to a greater reduction in anxiety symptoms compared to the waitlist control.
2. The effect of CoolMinds will be independent of the degree of therapist support.
Design:
The study is designed as a superiority randomized controlled trial with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally all participants that are active in the program for the first 8 weeks, will be randomized to receive or not receive a booster session 10 weeks after finishing the intervention with an allocation ratio of 1:1.
The study will be conducted at Center for Digital Psychiatry, an online clinic and research facility that is part of the psychiatric hospital in the region of southern Denmark, and at Center for Psychological Treatment of Children and Adolescents, a research and teaching center at Aarhus university, Denmark. All data will be collected from these two centers in Denmark.
Participants and recruitment:
All participants will have to register through a website to participate in the project. As part of the registration, the participants will have to fill out an initial screening questionnaire that assesses exclusion criteria. If an exclusion criteria is met, the participant will automatically be informed within the questionnaire that they are unable to participate and is given the choice to continue or discontinue their answering.
Data will be collected with a parent and adolescent questionnaire at five points: pre-treatment (T1), post-treatment (T2) and at follow-ups after 3, 6 and 12 months (T3, T4, T5). Participants in the waitlist control group will be offered guided iCBT with planned feedback at post-treatment (T2).
Among children and adolescents the most prevalent mental health conditions are anxiety disorders, with around 5-12% of youth in western countries fulfilling the criteria for an anxiety diagnosis. Evidence points to an increase in the prevalence of anxiety disorders during the transition from childhood to adolescence and from adolescence to adulthood up to age 30. Untreated anxiety disorders tend to chronify or become recurrent in the developmental course and persist into adulthood.
Cognitive behavioral therapy (CBT), in both individual and group format, is effective in treating young people with anxiety. Despite the existence of effective treatment options and the possible long-term consequences associated with untreated anxiety disorders in youth, it is estimated that less than 25% of children and adolescents with anxiety disorders receive professional help, with fewer receiving evidence-based treatment. Frequently mentioned barriers for adolescents opting to seek treatment include social stigma, shyness and fear of peer rejection, preference for self-reliance, confidentiality, privacy and anonymity concerns, worries concerning treatment costs, transportation or waiting times and limited availability of psychological treatment. Thus, it is of the utmost importance to consider these barriers when developing interventions to overcome these and thus increase treatment accessibility.
Internet-based cognitive behavioral therapy (iCBT) may be an effective alternative to face-to-face treatment, that can address some of the aforementioned barriers to treatment by providing greater flexibility, greater autonomy, reduced expenses, and eliminate travel time. To date, fourteen randomized controlled trials (RCTs) have evaluated iCBT programs in both children and adolescents with anxiety disorders. Four of these included predominantly or only adolescents and showed promising results with between group effect sizes ranging from d = 0.65-1.04 at follow-up.
Objectives
The primary aim of the present study is to examine the efficacy of an internet-delivered cognitive behavioral therapy intervention, CoolMinds, in adolescents aged 12-17 years, when delivered with planned feedback or on-demand feedback from a therapist compared to a waitlist control. Additionally, the study will explore the efficacy of delivering one booster session compared to none. It is hypothesized that:
1. CoolMinds will lead to a greater reduction in anxiety symptoms compared to the waitlist control.
2. The effect of CoolMinds will be independent of the degree of therapist support.
Design:
The study is designed as a superiority randomized controlled trial with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally all participants that are active in the program for the first 8 weeks, will be randomized to receive or not receive a booster session 10 weeks after finishing the intervention with an allocation ratio of 1:1.
The study will be conducted at Center for Digital Psychiatry, an online clinic and research facility that is part of the psychiatric hospital in the region of southern Denmark, and at Center for Psychological Treatment of Children and Adolescents, a research and teaching center at Aarhus university, Denmark. All data will be collected from these two centers in Denmark.
Participants and recruitment:
All participants will have to register through a website to participate in the project. As part of the registration, the participants will have to fill out an initial screening questionnaire that assesses exclusion criteria. If an exclusion criteria is met, the participant will automatically be informed within the questionnaire that they are unable to participate and is given the choice to continue or discontinue their answering.
Data will be collected with a parent and adolescent questionnaire at five points: pre-treatment (T1), post-treatment (T2) and at follow-ups after 3, 6 and 12 months (T3, T4, T5). Participants in the waitlist control group will be offered guided iCBT with planned feedback at post-treatment (T2).
Conditions
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Anxiety Disorders
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
The RCT is designed as a superiority RCT with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design.
Study Groups
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iCBT with planned feedback
Participants in this iCBT condition will receive written feedback from their therapist on assignments weekly. The participants will also be able to contact their assigned therapist through messages within the program and receive asynchronous support if needed. Participant depression and suicidality will also be continuously monitored using weekly questionnaires.
Group Type
EXPERIMENTAL
CoolMinds: Internet-based cognitive behavioral therapy (iCBT)
Intervention Type
BEHAVIORAL
The intervention consists of 14 weeks of iCBT, where the main treatment components are psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program comprises eleven sessions for adolescents and ten sessions for parents to be completed simultaneously. The participants will have the opportunity to get therapist feedback during the treatment period, the therapist may spend a maximum of 15 minutes giving feedback per week per participant.
iCBT with on-demand feedback
Participants in the on-demand iCBT condition will not receive any planned contact with the therapist. However, the participants will be able to contact the therapist through messages within the program and receive asynchronous support if needed. The therapist will also be monitoring the participants' answers on questionnaires and assignments to ensure progress. Participant depression and suicidality will also be continuously monitored using weekly questionnaires.
Group Type
EXPERIMENTAL
CoolMinds: Internet-based cognitive behavioral therapy (iCBT)
Intervention Type
BEHAVIORAL
The intervention consists of 14 weeks of iCBT, where the main treatment components are psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program comprises eleven sessions for adolescents and ten sessions for parents to be completed simultaneously. The participants will have the opportunity to get therapist feedback during the treatment period, the therapist may spend a maximum of 15 minutes giving feedback per week per participant.
waitlist control
A waitlist control is included to compare the treatment conditions to a no-treatment condition and serves as a control for the effects of time and assessment on efficacy. Participants in the waitlist condition will be instructed to wait 14 weeks. After the 14-week period, participants will be offered iCBT treatment with planned therapist feedback and with elective modules. If participants do not wish to receive the iCBT treatment, they will receive help in finding another relevant treatment if needed.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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CoolMinds: Internet-based cognitive behavioral therapy (iCBT)
The intervention consists of 14 weeks of iCBT, where the main treatment components are psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program comprises eleven sessions for adolescents and ten sessions for parents to be completed simultaneously. The participants will have the opportunity to get therapist feedback during the treatment period, the therapist may spend a maximum of 15 minutes giving feedback per week per participant.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Between 12 and 17 years of age.
* Have a principal anxiety diagnosis according to DSM-5 criteria.
* The ability to read and write Danish.
* Internet access.
* A parent able to participate in treatment alongside the adolescent.
* Have a principal anxiety diagnosis according to DSM-5 criteria.
* The ability to read and write Danish.
* Internet access.
* A parent able to participate in treatment alongside the adolescent.
Exclusion Criteria
* Autism spectrum disorder.
* Attention deficit hyperactivity disorder.
* Psychotic symptoms.
* Bipolar disorder.
* Current suicidal ideation or self-mutilating behavior.
* Current alcohol or substance abuse.
* A score of 5 or above on ADIS
* Current eating disorder.
* Received CBT for an anxiety disorder within the past 12 months.
* Attention deficit hyperactivity disorder.
* Psychotic symptoms.
* Bipolar disorder.
* Current suicidal ideation or self-mutilating behavior.
* Current alcohol or substance abuse.
* A score of 5 or above on ADIS
* Current eating disorder.
* Received CBT for an anxiety disorder within the past 12 months.
Minimum Eligible Age
12 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Aarhus
OTHER
Sponsor Role
collaborator
Region of Southern Denmark
OTHER
Sponsor Role
lead
Responsible Party
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Kim Mathiasen
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kim Mathiasen, P.hd
Role: PRINCIPAL_INVESTIGATOR
Region of Southern Denmark
Locations
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Centre for Digital Psychiatry
Odense, Region Syddanmark, Denmark
Site Status
RECRUITING
Countries
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Denmark
Central Contacts
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Facility Contacts
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References
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Spence SH, Donovan CL, March S, Kenardy JA, Hearn CS. Generic versus disorder specific cognitive behavior therapy for social anxiety disorder in youth: A randomized controlled trial using internet delivery. Behav Res Ther. 2017 Mar;90:41-57. doi: 10.1016/j.brat.2016.12.003. Epub 2016 Dec 8.
Reference Type
BACKGROUND
Spence SH, Holmes JM, March S, Lipp OV. The feasibility and outcome of clinic plus internet delivery of cognitive-behavior therapy for childhood anxiety. J Consult Clin Psychol. 2006 Jun;74(3):614-21. doi: 10.1037/0022-006X.74.3.614.
Reference Type
BACKGROUND
Stallard P, Velleman S, Richardson T. Computer Use and Attitudes Towards Computerised Therapy Amongst Young People and Parents Attending Child and Adolescent Mental Health Services. Child Adolesc Ment Health. 2010 May;15(2):80-84. doi: 10.1111/j.1475-3588.2009.00540.x. Epub 2009 Sep 24.
Reference Type
BACKGROUND
Stjerneklar S, Hougaard E, McLellan LF, Thastum M. A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders. PLoS One. 2019 Sep 18;14(9):e0222485. doi: 10.1371/journal.pone.0222485. eCollection 2019.
Reference Type
BACKGROUND
Storch EA, Salloum A, King MA, Crawford EA, Andel R, McBride NM, Lewin AB. A RANDOMIZED CONTROLLED TRIAL IN COMMUNITY MENTAL HEALTH CENTERS OF COMPUTER-ASSISTED COGNITIVE BEHAVIORAL THERAPY VERSUS TREATMENT AS USUAL FOR CHILDREN WITH ANXIETY. Depress Anxiety. 2015 Nov;32(11):843-52. doi: 10.1002/da.22399. Epub 2015 Sep 14.
Reference Type
BACKGROUND
Vigerland S, Ljotsson B, Thulin U, Ost LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Behav Res Ther. 2016 Jan;76:47-56. doi: 10.1016/j.brat.2015.11.006. Epub 2015 Nov 19.
Reference Type
BACKGROUND
Nordh M, Wahlund T, Jolstedt M, Sahlin H, Bjureberg J, Ahlen J, Lalouni M, Salomonsson S, Vigerland S, Lavner M, Ost LG, Lenhard F, Hesser H, Mataix-Cols D, Hogstrom J, Serlachius E. Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jul 1;78(7):705-713. doi: 10.1001/jamapsychiatry.2021.0469.
Reference Type
BACKGROUND
Polanczyk GV, Salum GA, Sugaya LS, Caye A, Rohde LA. Annual research review: A meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015 Mar;56(3):345-65. doi: 10.1111/jcpp.12381. Epub 2015 Feb 3.
Reference Type
BACKGROUND
Reardon T, Harvey K, Creswell C. Seeking and accessing professional support for child anxiety in a community sample. Eur Child Adolesc Psychiatry. 2020 May;29(5):649-664. doi: 10.1007/s00787-019-01388-4. Epub 2019 Aug 13.
Reference Type
BACKGROUND
Rickwood DJ, Braithwaite VA. Social-psychological factors affecting help-seeking for emotional problems. Soc Sci Med. 1994 Aug;39(4):563-72. doi: 10.1016/0277-9536(94)90099-x.
Reference Type
BACKGROUND
Rickwood DJ, Deane FP, Wilson CJ. When and how do young people seek professional help for mental health problems? Med J Aust. 2007 Oct 1;187(S7):S35-9. doi: 10.5694/j.1326-5377.2007.tb01334.x.
Reference Type
BACKGROUND
Angold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research.
Reference Type
BACKGROUND
Arendt K, Hougaard E, Thastum M. Psychometric properties of the child and parent versions of Spence children's anxiety scale in a Danish community and clinical sample. J Anxiety Disord. 2014 Dec;28(8):947-56. doi: 10.1016/j.janxdis.2014.09.021. Epub 2014 Oct 16.
Reference Type
BACKGROUND
Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.
Reference Type
BACKGROUND
Beesdo K, Knappe S, Pine DS. Anxiety and anxiety disorders in children and adolescents: developmental issues and implications for DSM-V. Psychiatr Clin North Am. 2009 Sep;32(3):483-524. doi: 10.1016/j.psc.2009.06.002.
Reference Type
BACKGROUND
Berg M, Rozental A, de Brun Mangs J, Nasman M, Stromberg K, Viberg L, Wallner E, Ahman H, Silfvernagel K, Zetterqvist M, Topooco N, Capusan A, Andersson G. The Role of Learning Support and Chat-Sessions in Guided Internet-Based Cognitive Behavioral Therapy for Adolescents With Anxiety: A Factorial Design Study. Front Psychiatry. 2020 Jun 10;11:503. doi: 10.3389/fpsyt.2020.00503. eCollection 2020.
Reference Type
BACKGROUND
Brooke, J. (1996). SUS: A "quick and dirty" usability scale. In J. B. W. Thomas, B. (Ed.), Usability evaluation in industry (pp. 189-194). London, UK: Taylor & Francis.
Reference Type
BACKGROUND
Costello EJ, Egger HL, Angold A. The developmental epidemiology of anxiety disorders: phenomenology, prevalence, and comorbidity. Child Adolesc Psychiatr Clin N Am. 2005 Oct;14(4):631-48, vii. doi: 10.1016/j.chc.2005.06.003.
Reference Type
BACKGROUND
Daviss WB, Birmaher B, Melhem NA, Axelson DA, Michaels SM, Brent DA. Criterion validity of the Mood and Feelings Questionnaire for depressive episodes in clinic and non-clinic subjects. J Child Psychol Psychiatry. 2006 Sep;47(9):927-34. doi: 10.1111/j.1469-7610.2006.01646.x.
Reference Type
BACKGROUND
Eg J, Bilenberg N, Costello EJ, Wesselhoeft R. Self- and parent-reported depressive symptoms rated by the mood and feelings questionnaire. Psychiatry Res. 2018 Oct;268:419-425. doi: 10.1016/j.psychres.2018.07.016. Epub 2018 Jul 22.
Reference Type
BACKGROUND
Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry. 2010 Dec 30;10:113. doi: 10.1186/1471-244X-10-113.
Reference Type
BACKGROUND
Herrero R, Vara MD, Miragall M, Botella C, Garcia-Palacios A, Riper H, Kleiboer A, Banos RM. Working Alliance Inventory for Online Interventions-Short Form (WAI-TECH-SF): The Role of the Therapeutic Alliance between Patient and Online Program in Therapeutic Outcomes. Int J Environ Res Public Health. 2020 Aug 25;17(17):6169. doi: 10.3390/ijerph17176169.
Reference Type
BACKGROUND
Hvidt, J. C. S., Christensen, L. F., Sibbersen, C., Helweg-Jørgensen, S., Hansen, J. P., & Lichtenstein, M. B. (2020). Translation and Validation of the System Usability Scale in a Danish Mental Health Setting Using Digital Technologies in Treatment Interventions. International journal of human-computer interaction, 36(8), 709-716. doi:10.1080/10447318.2019.1680922
Reference Type
BACKGROUND
James AC, Reardon T, Soler A, James G, Creswell C. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD013162. doi: 10.1002/14651858.CD013162.pub2.
Reference Type
BACKGROUND
Jolstedt M, Wahlund T, Lenhard F, Ljotsson B, Mataix-Cols D, Nord M, Ost LG, Hogstrom J, Serlachius E, Vigerland S. Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial. Lancet Child Adolesc Health. 2018 Nov;2(11):792-801. doi: 10.1016/S2352-4642(18)30275-X. Epub 2018 Sep 18.
Reference Type
BACKGROUND
Keller MB, Lavori PW, Wunder J, Beardslee WR, Schwartz CE, Roth J. Chronic course of anxiety disorders in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1992 Jul;31(4):595-9. doi: 10.1097/00004583-199207000-00003.
Reference Type
BACKGROUND
Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
Reference Type
BACKGROUND
Khanna MS, Kendall PC. Computer-assisted cognitive behavioral therapy for child anxiety: results of a randomized clinical trial. J Consult Clin Psychol. 2010 Oct;78(5):737-45. doi: 10.1037/a0019739.
Reference Type
BACKGROUND
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Reference Type
BACKGROUND
Leigh E, Clark DM. Internet-delivered therapist-assisted cognitive therapy for adolescent social anxiety disorder (OSCA): a randomised controlled trial addressing preliminary efficacy and mechanisms of action. J Child Psychol Psychiatry. 2023 Jan;64(1):145-155. doi: 10.1111/jcpp.13680. Epub 2022 Aug 9.
Reference Type
BACKGROUND
March S, Spence SH, Donovan CL. The efficacy of an internet-based cognitive-behavioral therapy intervention for child anxiety disorders. J Pediatr Psychol. 2009 Jun;34(5):474-87. doi: 10.1093/jpepsy/jsn099. Epub 2008 Sep 15.
Reference Type
BACKGROUND
McLellan LF, Kangas M, Rapee RM, Iverach L, Wuthrich VM, Hudson JL, Lyneham HJ. The Youth Online Diagnostic Assessment (YODA): Validity of a New Tool to Assess Anxiety Disorders in Youth. Child Psychiatry Hum Dev. 2021 Apr;52(2):270-280. doi: 10.1007/s10578-020-01007-3.
Reference Type
BACKGROUND
Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.
Reference Type
BACKGROUND
Merikangas KR, He JP, Burstein M, Swendsen J, Avenevoli S, Case B, Georgiades K, Heaton L, Swanson S, Olfson M. Service utilization for lifetime mental disorders in U.S. adolescents: results of the National Comorbidity Survey-Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):32-45. doi: 10.1016/j.jaac.2010.10.006. Epub 2010 Dec 3.
Reference Type
BACKGROUND
Messer, S. C., Angold, A., Costello, E. J., Loeber, R., Van Kammen, W., & Stouthamer-Loeber, M. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents: Factor composition and structure across development. International Journal of Methods in Psychiatric Research, 5, 251-262.
Reference Type
BACKGROUND
Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health--attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014 Apr 11;14:109. doi: 10.1186/1471-244X-14-109.
Reference Type
BACKGROUND
Nearchou FA, Bird N, Costello A, Duggan S, Gilroy J, Long R, McHugh L, Hennessy E. Personal and perceived public mental-health stigma as predictors of help-seeking intentions in adolescents. J Adolesc. 2018 Jul;66:83-90. doi: 10.1016/j.adolescence.2018.05.003. Epub 2018 May 23.
Reference Type
BACKGROUND
Spence SH, Donovan CL, March S, Gamble A, Anderson RE, Prosser S, Kenardy J. A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety. J Consult Clin Psychol. 2011 Oct;79(5):629-42. doi: 10.1037/a0024512.
Reference Type
BACKGROUND
Waite P, Marshall T, Creswell C. A randomized controlled trial of internet-delivered cognitive behaviour therapy for adolescent anxiety disorders in a routine clinical care setting with and without parent sessions. Child Adolesc Ment Health. 2019 Sep;24(3):242-250. doi: 10.1111/camh.12311. Epub 2019 Mar 6.
Reference Type
BACKGROUND
Wang PS, Angermeyer M, Borges G, Bruffaerts R, Tat Chiu W, DE Girolamo G, Fayyad J, Gureje O, Haro JM, Huang Y, Kessler RC, Kovess V, Levinson D, Nakane Y, Oakley Brown MA, Ormel JH, Posada-Villa J, Aguilar-Gaxiola S, Alonso J, Lee S, Heeringa S, Pennell BE, Chatterji S, Ustun TB. Delay and failure in treatment seeking after first onset of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry. 2007 Oct;6(3):177-85.
Reference Type
BACKGROUND
Wuthrich VM, Rapee RM, Cunningham MJ, Lyneham HJ, Hudson JL, Schniering CA. A randomized controlled trial of the Cool Teens CD-ROM computerized program for adolescent anxiety. J Am Acad Child Adolesc Psychiatry. 2012 Mar;51(3):261-70. doi: 10.1016/j.jaac.2011.12.002. Epub 2012 Jan 21.
Reference Type
BACKGROUND
Zhou X, Zhang Y, Furukawa TA, Cuijpers P, Pu J, Weisz JR, Yang L, Hetrick SE, Del Giovane C, Cohen D, James AC, Yuan S, Whittington C, Jiang X, Teng T, Cipriani A, Xie P. Different Types and Acceptability of Psychotherapies for Acute Anxiety Disorders in Children and Adolescents: A Network Meta-analysis. JAMA Psychiatry. 2019 Jan 1;76(1):41-50. doi: 10.1001/jamapsychiatry.2018.3070.
Reference Type
BACKGROUND
Skaarnes H, Sorensen NM, Wisnewski AH, Lomholt JJ, Thastum M, McLellan L, Mathiasen K. Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial. Trials. 2024 Oct 13;25(1):674. doi: 10.1186/s13063-024-08511-0.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22/59602
Identifier Type: -
Identifier Source: org_study_id
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