Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders

NCT06368557 | Recruiting DMC

• 1 other identifier: 22/59602
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
2. 2.What effect different degrees of therapist support have on the treatment.

Conditions

Anxiety Disorders

Keywords

Adolescents; Anxiety Disorders; Cognitive behavioral therapy; Internet-based; Digital health

Outcome Measures

Primary Outcomes (2)

• The Youth Online Diagnostic Assessment - Child and Parent Versions

  An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias based on the Anxiety and Related Disorders Interview Schedule for DSM-5, which is considered the golden standard.

  Pre-treatment, immediately after treatment and at 3-month follow-up

• Spence Children's Anxiety Scale- Child and Parent Versions

  A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV. The responses are scored on a 4 point scale ranging from 0 to 3, with a minimum score of 0 and a maximum score of 114, higher scores mean a higher level of anxiety.

  Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up

Secondary Outcomes (4)

• Child Anxiety Life Interference Scale- Child and Parent Version

  Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up

• The Mood and Feelings Questionnaire- Child and Parent Version

  Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up

• Working Alliance Inventory - Short Form

  Immediately after treatment and every 14 days during the treatment period

• Working Alliance Inventory for Online Interventions

  Immediately after treatment

Other Outcomes (11)

• Children´s Anxiety Scale

  weekly questionnaire

• The Short Mood and Feelings questionnaire

  Weekly questionnaire

• EuroQol-5 Dimension Youth

  Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up

Study Arms (3)

iCBT with planned feedback

EXPERIMENTAL

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.

Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)

iCBT with on-demand feedback

EXPERIMENTAL

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.

Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)

waitlist control

NO INTERVENTION

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.

Interventions

CoolMinds: Internet-based cognitive behavioral therapy (iCBT) 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; iCBT with planned feedback

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region of Southern Denmark: lead
• University of Aarhus: collaborator

Study Sites (1)

Centre for Digital Psychiatry

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Related Publications (43)

• 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.

  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.

  PMID: 25445085 BACKGROUND

• Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.

  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.

  PMID: 19716988 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.

  PMID: 32587533 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.

  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.

  PMID: 16171696 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.

  PMID: 16930387 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.

  PMID: 30130708 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.

  PMID: 21192795 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.

  PMID: 32854381 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

  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.

  PMID: 33196111 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.

  PMID: 30241993 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.

  PMID: 1644719 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.

  PMID: 15939837 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.

  PMID: 20873909 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.

  PMID: 11556941 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.

  PMID: 35943064 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.

  PMID: 18794187 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.

  PMID: 32440754 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.

  PMID: 20855043 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.

  PMID: 21156268 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.

  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.

  PMID: 24725765 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.

  PMID: 29800758 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.

  PMID: 33978699 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.

  PMID: 25649325 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.

  PMID: 31410579 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.

  PMID: 7973856 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.

  PMID: 17908023 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.

  PMID: 21744945 BACKGROUND

• 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.

  PMID: 27988427 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.

  PMID: 16822117 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.

  PMID: 32847246 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.

  PMID: 31532802 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.

  PMID: 26366886 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.

  PMID: 26649465 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.

  PMID: 32677216 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.

  PMID: 18188443 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.

  PMID: 22365462 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.

  PMID: 30383099 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.

  PMID: 39396991 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kim Mathiasen, P.hd

  Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene Skaarnes, MSc (Psych.)

CONTACT

0045 2964 9702; helene.skaarnes@rsyd.dk

Nikita M Sørensen, MSc (Psych.)

CONTACT

0045 87159439; nikita@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: April 16, 2024
• Study Start: October 10, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data is available for researchers from Aarhus University, center for psychological treatment of children and adolescents during and after the study is finished. For other the data will become available after the study is finished
• Access Criteria: There have been made an data sharing agreement between Aarhus University, center for psychological treatment of children and adolescents and the region of southern Denmark, the agreement must be followed Restrictions apply to the availability of data and approval is needed from Danish Data Protection Agency and or The Danish National Archives.

Locations

DK (1)