An interventional study of Internet-Delivered Cognitive Behavioral Therapy in ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Specific Phobia and Social Anxiety Disorder, sponsored by Lund University. Recruiting at 1 site in Sweden. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
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:
1. 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:
Participants will:
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/).
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 48 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) 8 to \<18 years of age.
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.
Exclusion Criteria:
1) Principal 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).
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Includes the intervention Internet-Delivered Cognitive-Behavioral Therapy.
Behavioral: Internet-Delivered Cognitive Behavioral Therapy
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.
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.
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).
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.
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)
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").
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)
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").
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)
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.
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
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.
Time frame: 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.
Time frame: 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.
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)
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.
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)
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.
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)
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.
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)
Used to assess anxiety symptoms. Child/adolescent-reported. Scores range from 0 to 6 points, with higher scores indicating more severe anxiety.
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
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.
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
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.
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
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).
Time frame: 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.
Time frame: 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).
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)
Used to assess treatment satisfaction. Child/adolescent-reported. The scale ranges from 9 to 36 points, with higher scores indicating greater satisfaction.
Time frame: 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.
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)
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.
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)
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.
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
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).
Time frame: 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.
Time frame: 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).
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)
Used to assess treatment satisfaction. Caregiver-reported. The scale ranges from 9 to 36 points, with higher scores indicating greater satisfaction.
Time frame: 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.
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)
Used to assess psychological inflexibility. Child/adolescent-reported. The scale ranges from 0 to 32 points, with higher scores indicating greater psychological inflexibility.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From week 12 and onwards (no specified end date in the study protocol).
Plan to share: 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.
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