ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)NCT06661460
Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
A study testing Internet-Delivered Cognitive Behavioral Therapy in people with ANXIETY DISORDERS (or Anxiety and Phobic Neuroses) and Specific Phobia, run by Lund University at 1 site in Sweden.
Trial summary
The goal of this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Specific Phobia, Social Anxiety Disorder
- What is being tested?
- Internet-Delivered Cognitive Behavioral Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 12 Dec 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1) 8 to <18 years of age.
- Confirmed by the child/caregiver and subsequently by the medical record system. 2) A principal DSM-5-TR anxiety disorder of specific phobia, separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder or agoraphobia.
- Confirmed by the Diagnostic Interview for Anxiety, Mood, and OCD and related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID).
- 3) Child and caregiver able to read, write and communicate in Swedish.
- Confirmed by the child/caregiver. 4) An available caregiver who can support the child in treatment.
- Confirmed by the caregiver. 5) Access to a smartphone, tablet, or laptop/desktop device, and the internet.
- Confirmed by the child/caregiver.
Who cannot join
- 1) Principal DSM-5-TR anxiety disorder of specific phobia concerning the domain of blood-injection-injury (due to the ICBT program not including relevant information on applied-tension techniques to avoid fainting during exposure exercises).
- Confirmed by a blood-injection-injury phobia being classified as the principal anxiety disorder as assessed by the DIAMOND-KID.
- 2) Established or suspected intellectual disability.
- Confirmed by the caregiver (through previous diagnosis) and/or by attending a special needs school for learning difficulties.
- 3) Another mental disorder in more immediate need of management than an anxiety disorder (e.g., schizophrenia spectrum and other psychotic disorders, bipolar disorder, anorexia nervosa, substance use disorders).
- According to the DIAMOND-KID and/or other available sources. 4) Social/familial/educational difficulties in more immediate need of management than an anxiety disorder.
Show all 14Show fewer
- Confirmed by the assessor through information from the child/caregiver and/or other available sources.
- 5) Immediate risk to self or others that require urgent attention, such as acute suicidality.
- Confirmed by the assessor through information from the child/caregiver and other available sources.
- 6) Previous CBT for an anxiety disorder, defined as five or more sessions with a certified CBT therapist within the 12 months prior to assessment.
- Confirmed by the child/caregiver or the medical record system. 7) Ongoing psychological treatment for an anxiety disorder.
- Confirmed by the child/caregiver or the medical record system. 8) Initiation or adjustment of any psychotropic medication for anxiety (i.e., selective serotonin reuptake inhibitors, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor or antipsychotics) within 8 weeks prior to assessment.
- Confirmed by the child/caregiver or the medical record system. 9) Participation in user involvement sessions in the present study.
- Confirmed by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Barn- och ungdomshälsan, Länssjukhuset
Kalmar, Region Kalmar Län, 391 85
Sandra Andrekson, Lic. psychologist, +46 73-595 38 31, sandra.andrekson@med.lu.se
About this study
Official title: Development and Preliminary Evaluation of a New Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
The goal of this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public representatives, and conduct a preliminary evaluation of the treatment effects in an open clinical trial.
The primary objective of the study is:
Read more
- To evaluate the preliminary efficacy of a newly developed ICBT intervention for children and adolescents with anxiety disorders in reducing anxiety severity, as measured by the Pediatric Anxiety Rating Scale (PARS).
Secondary objectives of the study are:
- To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment.
- To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention.
- To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome.
- To examine how the ICBT intervention can be improved (e.g., treatment content and technical delivery) for future use.
Participants will:
- Undergo ICBT treatment for anxiety disorders during 12 weeks
- Complete questionnaires at multiple time points throughout the study
- Participate in follow-ups post-treatment and 3 months post-treatment
- A selection of participants will also be invited to focus group interviews with the aim to generate ideas on how the intervention may be improved for future use
Read the detailed description
A detailed description is available in the full study protocol. All full study protocol versions may be accessed at the Open Science Framework (https://osf.io/fdnga/).
- Conditions
- ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Specific Phobia, Social Anxiety Disorder, Separation Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder
- Being tested
- Internet-Delivered Cognitive Behavioral Therapy
- Keywords
- Anxiety disorders, Children, Adolescents, Cognitive Behavioral Therapy, Remote delivery, Internet, Internet-delivered cognitive behavioral therapy
- Medical subject headings
- Anxiety Disorders, Phobic Disorders, Phobia, Specific, Phobia, Social, Anxiety, Separation, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Delivered Cognitive Behavioral TherapyBehavioural
The intervention is a therapist-guided, internet-delivered cognitive behavioral therapy (ICBT) program primarily based on exposure therapy, involving the gradual confrontation of feared situations and/or stimuli. Treatment is accessed through a smartphone, tablet or laptop/desktop device. The 12-week intervention is available in two different versions depending on the participant's age: one for 8-12-year-olds and one for 13-17-year-olds. Each version consists of separate logins to 12 modules (chapters) for the child/adolescent and 12 modules for the caregivers. Both the child/adolescent and caregiver have individual contact with a trained therapist over the internet platform. The therapist provides feedback, responds to questions and sends reminders to complete the next module if required. Communication is carried out via text messages in the platform, via telephone (if deemed justified) and through a scheduled telephone or videoconference call approximately 4-5 weeks into treatment.
| Study group | Role | What they receive |
|---|---|---|
| Internet-Delivered Cognitive-Behavioral Therapy | Experimental | Includes the intervention Internet-Delivered Cognitive-Behavioral Therapy. Receives: Behavioral: Internet-Delivered Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anxiety Rating Scale (PARS)
Used to assess anxiety severity. Clinician-rated. The scale yields a score of 0 to 35, with higher scores indicating more severe anxiety.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Secondary outcomes (31)
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID)
Used to assess anxiety disorders and psychiatric comorbidity at baseline and anxiety disorders and major depression at follow-ups. Clinician-rated.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Clinical Global Impression Scale - Severity (CGI-S)
Used to assess overall anxiety severity. Clinician-rated. Ratings are reported on a seven-graded scale from 1 ("Normal, not at all ill") to 7 ("Among the most extremely ill patients").
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Clinical Global Impression Scale - Improvement (CGI-I)
Used to assess level of improvement compared to admission. Clinician-rated. This single item scale ranges from 1 ("Very much improved") to 7 ("Very much worse").
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Children's Global Assessment Scale (CGAS)
Used to assess global impairment. Clinician-rated. The CGAS is a single item scale that ranges from 1 to 100, with a higher value indicating better functioning.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Therapist time
Therapist time: preparation time, support time in platform, support time via telephone, support time via videoconference, and documentation time. Reported in minutes per participant per week for each variable as well as combined.
Measured: Consecutively throughout the 12 week treatment period.
Module completion
Completion of modules in the internet platform for each child/adolescent and each caregiver. Ranges from 0 to 12 modules. Reported separately for children, adolescents, caregivers of children, and caregivers of adolescents.
Measured: Consecutively throughout the 12 week treatment period.
Number of participants with concomitant interventions
Used to assess potential other treatments during the study period. Clinician-rated.
Measured: Post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Revised Child Anxiety and Depression Scale - Child version (RCADS-C)
Used to assess anxiety symptoms. Child/adolescent-reported. The RCADS version used in the present study is the 47-item version which ranges from 0 to 141 points, with higher scores indicating more severe internalizing symptoms.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)
Used to assess life interference and impairment associated with childhood anxiety. The scale ranges from 0 to 36 points, with higher scores indicating higher interference and impairment. Child/adolescent-reported.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Patient Health Questionnaire-2 (PHQ-2)
Used to assess mood and anhedonia symptoms. Child/adolescent-reported. Scores range from 0 to 6 points, with higher scores indicating more severe internalizing symptoms.
Measured: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Generalized Anxiety Disorder-2 (GAD-2)
Used to assess anxiety symptoms. Child/adolescent-reported. Scores range from 0 to 6 points, with higher scores indicating more severe anxiety.
Measured: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Well-being
Used to assess well-being, operationalized as satisfaction with life, overall happiness, and how much the person would change about their life if they could. Child/adolescent-reported. Scores range from 3 to 33 points, with higher scores indicating higher well-being.
Measured: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Mood and Feelings Questionnaire (MFQ) - Suicidality item
Single item taken from the Mood and Feelings Questionnaire (MFQ) used to assess suicidal ideation. Child/adolescent-reported. Scores range from 0 to 3 points, with higher scores indicating higher suicidal ideation.
Measured: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Experiences of CBT - Child version
Used to assess experiences of receiving CBT. Child/adolescent-reported. The scale consists of 7 items (baseline), 12 items (3, 6, and 9 weeks into treatment; post-treatment). The baseline version consists of two separate scores ranging from 5 to 50 points (higher scores indicate a better treatment experience) and from 2 to 20 points (higher scores indicate a higher level of distress and interference). The mid- and post-treatment versions consist of three separate scores ranging from 9 to 90 points (higher scores indicate a better treatment experience), from 2 to 20 points (higher scores indicate a higher level of distress and interference), and from 1 to 6 points (higher scores indicate more time spent on treatment).
Measured: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Working alliance - Child version
Used to assess the participant's perceived working alliance with their therapist. Child/adolescent-reported. The scale ranges from 0 to 36 points, with higher scores indicating better working alliance.
Measured: 3, 6, and 9 weeks into treatment.
Adverse events questionnaire - Child version (AEQ-C)
Used to assess adverse events/effects. Child/adolescent-reported. The scale consists of 22 yes/no items (score range 0-22 points) with higher scores indicating more present adverse events. For each adverse event that is present, there is also a rating of whether the adverse event is thought to be related to the provided treatment (yes or no).
Measured: 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Client Satisfaction Questionnaire - Child version (CSQ-8-C)
Used to assess treatment satisfaction. Child/adolescent-reported. The scale ranges from 9 to 36 points, with higher scores indicating greater satisfaction.
Measured: Post-treatment (window of 12 to 18 weeks post-enrollment).
Need for treatment - Child version
Used to assess the need of treatment for anxiety symptoms. Child/adolescent-reported. This single item scale ranges from 0 to 5 points, with higher scores indicating a higher need for treatment.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)
Used to assess anxiety symptoms. Caregiver-reported. The RCADS version used in the present study is the 47-item version which ranges from 0 to 141 points, with higher scores indicating more severe internalizing symptoms.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)
Used to assess life interference and impairment associated with childhood anxiety. Caregiver-reported. The scale ranges from 0 to 36 points, with higher scores indicating higher interference and impairment.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Experiences of CBT - Parent version
Used to assess experiences of receiving CBT. Child/adolescent-reported. The scale consists of 7 items (baseline), 12 items (3, 6, and 9 weeks into treatment; post-treatment). The baseline version consists of two separate scores ranging from 5 to 50 points (higher scores indicate a better treatment experience) and from 2 to 20 points (higher scores indicate a higher level of distress and interference). The mid- and post-treatment versions consist of three separate scores ranging from 9 to 90 points (higher scores indicate a better treatment experience), from 2 to 20 points (higher scores indicate a higher level of distress and interference), and from 1 to 6 points (higher scores indicate more time spent on treatment).
Measured: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Working alliance - Parent version
Used to assess the caregiver's perceived working alliance with their therapist. Caregiver-reported. The scale ranges from 0 to 36 points, with higher scores indicating better working alliance.
Measured: 3, 6, and 9 weeks into treatment.
Adverse events questionnaire - Parent version (AEQ-P)
Used to assess adverse events/effects. Parent-reported. The scale consists of 22 yes/no items (score range 0-22 points) with higher scores indicating more present adverse events. For each adverse event that is present, there is also a rating of whether the adverse event is thought to be related to the provided treatment (yes or no).
Measured: 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Client Satisfaction Questionnaire - Parent version (CSQ-8-P)
Used to assess treatment satisfaction. Caregiver-reported. The scale ranges from 9 to 36 points, with higher scores indicating greater satisfaction.
Measured: Post-treatment (window of 12 to 18 weeks post-enrollment).
Need for treatment - Parent version
Used to assess the need of treatment for anxiety symptoms. Caregiver-reported. This single item scale ranges from 0 to 5 points, with higher scores indicating a higher need for treatment.
Measured: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
Used to assess psychological inflexibility. Child/adolescent-reported. The scale ranges from 0 to 32 points, with higher scores indicating greater psychological inflexibility.
Measured: Baseline.
The Cognitive-attentional Syndrome Questionnaire (CAS-1)
Used to assess dysfunctional metacognitive beliefs. Child/adolescent-reported. The questionnaire consists of four domains. Each item of the three first domains is scored on a 0-8 point scale. Each item of the fourth domain is score on 0-100 scale. Higher scores indicates more dysfunctional metacognitive beliefs.
Measured: Baseline.
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
Used to assess attention difficulties, hyperactivity, impulsivity, and oppositional symptoms. Caregiver-reported. Each item is scored from 0 to 3 points. The item scores are then summarized in domains: inattention (items 1-9), hyperactivity-impulsivity (items 11-19) and oppositional (items 21-28). Items 10, 20 and 29 are not included in any of the domains. Higher scores indicate greater attention difficulties, hyperactivity, impulsivity, and oppositional symptoms.
Measured: Baseline.
Core autism traits - Child version
Used to assess core autism traits. Child/adolescent-reported. The scale ranges from 0 to 36 points, with higher scores indicating greater autism traits.
Measured: Baseline.
Core autism traits - Parent version
Used to assess core autism traits. Caregiver-reported. The scale ranges from 0 to 36 points, with higher scores indicating greater autism traits.
Measured: Baseline.
Focus groups
Qualitative data will be gathered through focus group interviews with the aim of generating novel ideas on how to enhance the ICBT intervention to better suit its target group. Four different types of focus groups will be compiled from the open clinical trial participants: children aged 8-12 years, b) caregivers of these children; c) adolescents aged 13-17 years; and d) caregivers of these adolescents.
Measured: From week 12 and onwards (no specified end date in the study protocol).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start12 Dec 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Studies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Andrén, PhD, Principal investigator, Department of Clinical Sciences, Lund, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661460
- Sponsor's protocol ID
- 2024-04296-01
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data are pseudonymized according to national (Swedish) and European Union legislation and cannot be anonymized and published in an open repository. Participants in the study consent for their data to be shared with other international researchers for research purposes. The data can be made available upon reasonable request on a case-by-case basis according to the current legislation and ethical permits.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Preliminary Evaluation of a New Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06661460
- Acronym / sponsor ID
- 2024-04296-01
- Conditions
- ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Specific Phobia, Social Anxiety Disorder, Separation Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder
- Keywords
- Anxiety disorders, Children, Adolescents, Cognitive Behavioral Therapy, Remote delivery, Internet, Internet-delivered cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Oct 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 this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public representatives, and conduct a preliminary evaluation of the treatment effects in an open clinical trial.
The primary objective of the study is:
- To evaluate the preliminary efficacy of a newly developed ICBT intervention for children and adolescents with anxiety disorders in reducing anxiety severity, as measured by the Pediatric Anxiety Rating Scale (PARS).
Secondary objectives of the study are:
- To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment.
- To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention.
- To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome.
- To examine how the ICBT intervention can be improved (e.g., treatment content and technical delivery) for future use.
Participants will:
- Undergo ICBT treatment for anxiety disorders during 12 weeks
- Complete questionnaires at multiple time points throughout the study
- Participate in follow-ups post-treatment and 3 months post-treatment
- A selection of participants will also be invited to focus group interviews with the aim to generate ideas on how the intervention may be improved for future use
Detailed description
A detailed description is available in the full study protocol. All full study protocol versions may be accessed at the Open Science Framework (https://osf.io/fdnga/).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-Delivered Cognitive-Behavioral Therapy | Experimental | Behavioral: Internet-Delivered Cognitive Behavioral TherapyIncludes the intervention Internet-Delivered Cognitive-Behavioral Therapy. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 1) 8 to <18 years of age.
- Confirmed by the child/caregiver and subsequently by the medical record system. 2) A principal DSM-5-TR anxiety disorder of specific phobia, separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder or agoraphobia.
- Confirmed by the Diagnostic Interview for Anxiety, Mood, and OCD and related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID).
- 3) Child and caregiver able to read, write and communicate in Swedish.
- Confirmed by the child/caregiver. 4) An available caregiver who can support the child in treatment.
Key exclusion criteria (14 listed)
- 1) Principal DSM-5-TR anxiety disorder of specific phobia concerning the domain of blood-injection-injury (due to the ICBT program not including relevant information on applied-tension techniques to avoid fainting during exposure exercises).
- Confirmed by a blood-injection-injury phobia being classified as the principal anxiety disorder as assessed by the DIAMOND-KID.
- 2) Established or suspected intellectual disability.
- Confirmed by the caregiver (through previous diagnosis) and/or by attending a special needs school for learning difficulties.
- 3) Another mental disorder in more immediate need of management than an anxiety disorder (e.g., schizophrenia spectrum and other psychotic disorders, bipolar disorder, anorexia nervosa, substance use disorders).
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 |
|---|---|---|
| Internet-Delivered Cognitive Behavioral TherapyThe intervention is a therapist-guided, internet-delivered cognitive behavioral therapy (ICBT) program primarily based on exposure therapy, involving the gradual confrontation of feared situations and/or stimuli. Treatment is accessed through a smartphone, tablet or laptop/desktop device. The 12-week intervention is available in two different versions depending on the participant's age: one for 8-12-year-olds and one for 13-17-year-olds. Each version consists of separate logins to 12 modules (chapters) for the child/adolescent and 12 modules for the caregivers. Both the child/adolescent and caregiver have individual contact with a trained therapist over the internet platform. The therapist provides feedback, responds to questions and sends reminders to complete the next module if required. Communication is carried out via text messages in the platform, via telephone (if deemed justified) and through a scheduled telephone or videoconference call approximately 4-5 weeks into treatment. | Behavioural | Internet-Delivered Cognitive-Behavioral Therapy |
Primary outcome
Pediatric Anxiety Rating Scale (PARS)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Used to assess anxiety severity. Clinician-rated. The scale yields a score of 0 to 35, with higher scores indicating more severe anxiety.
31 secondary outcomes
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Clinical Global Impression Scale - Severity (CGI-S)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Children's Global Assessment Scale (CGAS)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Therapist time
Time frame: Consecutively throughout the 12 week treatment period.
Module completion
Time frame: Consecutively throughout the 12 week treatment period.
Number of participants with concomitant interventions
Time frame: Post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Revised Child Anxiety and Depression Scale - Child version (RCADS-C)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Generalized Anxiety Disorder-2 (GAD-2)
Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Well-being
Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Mood and Feelings Questionnaire (MFQ) - Suicidality item
Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Experiences of CBT - Child version
Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Working alliance - Child version
Time frame: 3, 6, and 9 weeks into treatment.
Adverse events questionnaire - Child version (AEQ-C)
Time frame: 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Client Satisfaction Questionnaire - Child version (CSQ-8-C)
Time frame: Post-treatment (window of 12 to 18 weeks post-enrollment).
Need for treatment - Child version
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Experiences of CBT - Parent version
Time frame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Working alliance - Parent version
Time frame: 3, 6, and 9 weeks into treatment.
Adverse events questionnaire - Parent version (AEQ-P)
Time frame: 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
Client Satisfaction Questionnaire - Parent version (CSQ-8-P)
Time frame: Post-treatment (window of 12 to 18 weeks post-enrollment).
Need for treatment - Parent version
Time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
Time frame: Baseline.
The Cognitive-attentional Syndrome Questionnaire (CAS-1)
Time frame: Baseline.
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
Time frame: Baseline.
Core autism traits - Child version
Time frame: Baseline.
Core autism traits - Parent version
Time frame: Baseline.
Focus groups
Time frame: From week 12 and onwards (no specified end date in the study protocol).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- All full study protocol versions are published at the Open Science Framework (OSF).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The data are pseudonymized according to national (Swedish) and European Union legislation and cannot be anonymized and published in an open repository. Participants in the study consent for their data to be shared with other international researchers for research purposes. The data can be made available upon reasonable request on a case-by-case basis according to the current legislation and ethical permits.
Related trials for ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Virtual Reality for Pain and Well-Being in Older Adults
Chronic Pain, Kinesiophobia (Fear of Movement)
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Active, not recruiting
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
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.
Per Andrén, PhD principal investigator
Department of Clinical Sciences, Lund, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Delivered Cognitive Behavioral Therapy in people with ANXIETY DISORDERS (or Anxiety and Phobic Neuroses) and Specific Phobia, run by Lund University at 1 site in Sweden.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Andrén, PhD (+46 70-435 17 40, per.andren@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anxiety Rating Scale (PARS) (time frame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.