Anxiety DisordersNCT06368557
Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
A study testing CoolMinds: Internet-based cognitive behavioral therapy (iCBT) in people with Anxiety Disorders, run by Region of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- CoolMinds: Internet-based cognitive behavioral therapy (iCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Autism spectrum disorder.
- Attention deficit hyperactivity disorder.
- Psychotic symptoms.
- Bipolar disorder.
- Current suicidal ideation or self-mutilating behavior.
- Current alcohol or substance abuse.
Show all 9Show fewer
- A score of 5 or above on ADIS
- Current eating disorder.
- Received CBT for an anxiety disorder within the past 12 months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Centre for Digital Psychiatry
Odense, Region Syddanmark, 5000
Helene Skaarnes, MSc (psych)), +4529649702, helene.skaarnes@rsyd.dk
Kim Mathiasen, Ph.d., +4561677747, kmathiasen@health.sdu.dk
About this study
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:
Read more
- If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
- 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.
Read the detailed description
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:
- CoolMinds will lead to a greater reduction in anxiety symptoms compared to the waitlist control.
- 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
- Anxiety Disorders
- Being tested
- CoolMinds: Internet-based cognitive behavioral therapy (iCBT)
- Keywords
- Adolescents, Anxiety Disorders, Cognitive behavioral therapy, Internet-based, Digital health
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolMinds: Internet-based cognitive behavioral therapy (iCBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
A 10-item self-report questionnaire assessing the impact of youth anxiety on various areas of life functioning such as school, extracurricular activities, family life and friendships. The responses are scored on a likert scale ranging from 0 to 4, with higher scores indicating higher anxiety life interference, minimum score is 0, maximum score is 36.
Measured: Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
The Mood and Feelings Questionnaire- Child and Parent Version
A 33-item self-report questionnaire assessing depression in youth, The responses are scored from 0 to 2, with higher scores suggest more severe depressive symptoms. Minimum score is 0, maximum score is 66.
Measured: Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
Working Alliance Inventory - Short Form
A 12-item self-report questionnaire assessing the therapeutic alliance, the responses are scored from 1 to 7, minimum total score 12 to maximum total score of 84, higher scores reflect a more positive rating of working alliance.
Measured: Immediately after treatment and every 14 days during the treatment period
Working Alliance Inventory for Online Interventions
A 36- items self-report questionnaire assessing the technical alliance, the responses are scored from 1 to 7, minimum total score 36 to maximum total score of 252, higher scores reflect a more positive rating of working alliance.
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start10 Oct 2023
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Kim Mathiasen, Region of Southern Denmark
- Investigators
- Kim Mathiasen, P.hd, Principal investigator, Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368557
- Sponsor's protocol ID
- 22/59602
- Status last verified
- Apr 2024
- First submitted
- 16 Oct 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for researches at Aarhus University, center for psychological treatment of children and adolescents. They will have access to study protocol, statistical analysis plan, informed consent form, clinical study report and analytical code. Data will also be stored on a server located in the Region of Southern Denmark. When the study is finished the data will be transferred to The Danish National Archives. Data are available upon reasonable request. Restrictions apply to the availability of data and approval is needed from Danish Data Protection Agency and or The Danish National Archives.
Publications
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.
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.
PubMed 25445085Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.
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.
PubMed 19716988Berg 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.
PubMed 32587533Brooke, 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.
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.
PubMed 16171696Daviss 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.
PubMed 16930387Eg 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.
PubMed 30130708Gulliver 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.
PubMed 21192795Herrero 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.
PubMed 32854381Hvidt, 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
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.
PubMed 33196111Jolstedt 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.
PubMed 30241993Keller 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.
PubMed 1644719
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06368557
- Acronym / sponsor ID
- 22/59602
- Conditions
- Anxiety Disorders
- Keywords
- Adolescents, Anxiety Disorders, Cognitive behavioral therapy, Internet-based, Digital health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
- 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.
Detailed description
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:
- CoolMinds will lead to a greater reduction in anxiety symptoms compared to the waitlist control.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| iCBT with planned feedback | Experimental | Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)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. |
| iCBT with on-demand feedback | Experimental | Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)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. |
| 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Autism spectrum disorder.
- Attention deficit hyperactivity disorder.
- Psychotic symptoms.
- Bipolar disorder.
- Current suicidal ideation or self-mutilating behavior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | iCBT with on-demand feedback, iCBT with planned feedback |
Primary outcome
The Youth Online Diagnostic Assessment - Child and Parent Versions
Time frame: Pre-treatment, immediately after treatment and at 3-month follow-up
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.
Spence Children's Anxiety Scale- Child and Parent Versions
Time frame: Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
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.
4 secondary outcomes
Child Anxiety Life Interference Scale- Child and Parent Version
Time frame: Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
The Mood and Feelings Questionnaire- Child and Parent Version
Time frame: Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
Working Alliance Inventory - Short Form
Time frame: Immediately after treatment and every 14 days during the treatment period
Working Alliance Inventory for Online Interventions
Time frame: Immediately after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- BackgroundAngold, 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: PubMed 25445085Arendt 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.
- BackgroundAttkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.
- Background: PubMed 19716988Beesdo 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.
- Background: PubMed 32587533Berg 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.
- BackgroundBrooke, 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: PubMed 16171696Costello 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.
- Background: PubMed 16930387Daviss 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.
- Background: PubMed 30130708Eg 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.
- Background: PubMed 21192795Gulliver 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.
- Background: PubMed 32854381Herrero 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.
- BackgroundHvidt, 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
- Individual participant dataSharing planned: Yes. Data will be available for researches at Aarhus University, center for psychological treatment of children and adolescents. They will have access to study protocol, statistical analysis plan, informed consent form, clinical study report and analytical code. Data will also be stored on a server located in the Region of Southern Denmark. When the study is finished the data will be transferred to The Danish National Archives. Data are available upon reasonable request. Restrictions apply to the availability of data and approval is needed from Danish Data Protection Agency and or The Danish National Archives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Mathiasen, P.hd principal investigator
Region of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoolMinds: Internet-based cognitive behavioral therapy (iCBT) in people with Anxiety Disorders, run by Region of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helene Skaarnes, MSc (Psych.) (0045 2964 9702, helene.skaarnes@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Youth Online Diagnostic Assessment - Child and Parent Versions (time frame: Pre-treatment, immediately after treatment and at 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368557, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.