Clinical trial NCT06661460: Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
Official title: Development and Preliminary Evaluation of a New Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Specific Phobia
Social Anxiety Disorder
Separation Anxiety Disorder
Generalized Anxiety Disorder
Panic Disorder
Agoraphobia
Keywords: Anxiety disorders
Children
Adolescents
Cognitive Behavioral Therapy
Remote delivery
Internet
Internet-delivered cognitive behavioral therapy
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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:

1. To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment.
2. To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention.
3. To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome.
4. 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/).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.
* 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.

Primary outcomes:
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: 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:
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version (DIAMOND-KID)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Therapist time
timeFrame: Consecutively throughout the 12 week treatment period.
measure: Module completion
timeFrame: Consecutively throughout the 12 week treatment period.
measure: Number of participants with concomitant interventions
timeFrame: Post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Revised Child Anxiety and Depression Scale - Child version (RCADS-C)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: 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).
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: 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).
measure: Well-being
timeFrame: 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).
measure: Mood and Feelings Questionnaire (MFQ) - Suicidality item
timeFrame: 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).
measure: Experiences of CBT - Child version
timeFrame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
measure: Working alliance - Child version
timeFrame: 3, 6, and 9 weeks into treatment.
measure: Adverse events questionnaire - Child version (AEQ-C)
timeFrame: 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
measure: Client Satisfaction Questionnaire - Child version (CSQ-8-C)
timeFrame: Post-treatment (window of 12 to 18 weeks post-enrollment).
measure: Need for treatment - Child version
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Experiences of CBT - Parent version
timeFrame: Baseline; 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
measure: Working alliance - Parent version
timeFrame: 3, 6, and 9 weeks into treatment.
measure: Adverse events questionnaire - Parent version (AEQ-P)
timeFrame: 3, 6, and 9 weeks into treatment; post-treatment (window of 12 to 18 weeks post-enrollment).
measure: Client Satisfaction Questionnaire - Parent version (CSQ-8-P)
timeFrame: Post-treatment (window of 12 to 18 weeks post-enrollment).
measure: Need for treatment - Parent version
timeFrame: Baseline; post-treatment (window of 12 to 18 weeks post-enrollment); 3-months post-treatment (window of 23 to 31 weeks post-enrollment).
measure: Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
timeFrame: Baseline.
measure: The Cognitive-attentional Syndrome Questionnaire (CAS-1)
timeFrame: Baseline.
measure: Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
timeFrame: Baseline.
measure: Core autism traits - Child version
timeFrame: Baseline.
measure: Core autism traits - Parent version
timeFrame: Baseline.
measure: Focus groups
timeFrame: From week 12 and onwards (no specified end date in the study protocol).
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Barn- och ungdomshälsan, Länssjukhuset
state: Region Kalmar Län
Study officials:
affiliation: Department of Clinical Sciences, Lund, Lund University
name: Per Andrén, PhD
role: PRINCIPAL_INVESTIGATOR
References: