Anxiety Disorders Clinical Trial
Official title:
Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
NCT number | NCT06368557 |
Other study ID # | 22/59602 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2023 |
Est. completion date | June 2025 |
The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are: 1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist. 2. 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.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Autism spectrum disorder. - Attention deficit hyperactivity disorder. - Psychotic symptoms. - Bipolar disorder. - Current suicidal ideation or self-mutilating behavior. - Current alcohol or substance abuse. - A score of 5 or above on ADIS - Current eating disorder. - Received CBT for an anxiety disorder within the past 12 months. |
Country | Name | City | State |
---|---|---|---|
Denmark | Centre for Digital Psychiatry | Odense | Region Of Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Region of Southern Denmark | University of Aarhus |
Denmark,
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Children´s Anxiety Scale | A 8-item abbreviated version of the Spence Children's Anxiety Scale containing 8 of the original 44-items. The responses are scored from 0 to 3, with a minimum total score of 0, to a maximum total score of 24. Higher scores mean a higher level of anxiety. | weekly questionnaire | |
Other | The Short Mood and Feelings questionnaire | A 13-items self-report questionnaire with an added item about suicidal thoughts and ideation will assess the level of depressive symptoms and risk of suicide. The responses are scored from 0 to 2, with a minimum total score of 0, to a maximum total score of 26. with higher scores suggest more severe depressive symptoms. | Weekly questionnaire | |
Other | EuroQol-5 Dimension Youth | A 5-item self-report questionnaire assessing quality of life and self-rated health. The items cover five domains: mobility, selfcare, usual activities, pain/discomfort, and anxiety and depression. The responses are scored from 1 to 5, with a minimum total score of 5, to a maximum total score of 25. Higher score suggest problems with the different dimensions. | Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up | |
Other | Client Satisfaction Questionnaire-8 | An 8-item questionnaire used to measure general satisfaction with a received treatment.The responses are scored from 1 to 4, with a minimum total score of 8, to a maximum total score of 32, with higher scores indicating greater satisfaction. | Immediately after treatment | |
Other | Systems Usability Scale | A 10-item questionnaire used to assess the subjective experience of usability of a higher score computer system. The responses are scored from 1 to 5, the participant´s scores for each question are converted to a new number, added together and then multiplied by 2.5 to make a scale with a minimum total score of 0, to a maximum total score of 100. A higher score indicates greater system usability. | Immediately after treatment | |
Other | Negative Effects Questionnaire | A 20-item questionnaire used to monitor the occurrence of negative effects in psychological treatments. The responses are scored from 0-4, with a minimum total score of 0, to a maximum total score of 80. A higher score indicates, more negative effects. | Immediately after treatment | |
Other | Sociodemographic measures | s will be gathered on parents regarding age, level of education, civil status, gender and primary caregiver in case of single parents. For the adolescents, information will be gathered regarding age and gender | pre-treatment | |
Other | Engagement | with the treatment will be measured objectively using the number of logins to the treatment program as well as number of words per message sent to the therapist and number of words per text box in the modules. This will be registered for both adolescents and parents. | Immediately after treatment | |
Other | Cost-effectiveness | Will be measured by self-report questionnaire about the number of days absent from school, if they have been in contact with self-paid psychiatrist or psychologist during the study and the use of communal services. | Immediately after treatment | |
Other | Cost-effectiveness | Will be measured by the time the parent and adolescent spent in the program, as well the therapists time spent on each patient. | Immediately after treatment | |
Other | The Anxiety Disorders Interview Schedule for Children | Depression will be measured oral during the clinical interview, with The Anxiety Disorders Interview Schedule for Children as The Youth Online Diagnostic Assessment depression module is not translated to Danish. | pre-treatment | |
Primary | The Youth Online Diagnostic Assessment - Child and Parent Versions | An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias based on the Anxiety and Related Disorders Interview Schedule for DSM-5, which is considered the golden standard. | Pre-treatment, immediately after treatment and at 3-month follow-up | |
Primary | Spence Children's Anxiety Scale- Child and Parent Versions | A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV. The responses are scored on a 4 point scale ranging from 0 to 3, with a minimum score of 0 and a maximum score of 114, higher scores mean a higher level of anxiety. | Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up | |
Secondary | 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. | Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up | |
Secondary | 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. | Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up | |
Secondary | 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. | Immediately after treatment and every 14 days during the treatment period | |
Secondary | 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. | Immediately after treatment |
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