Anxiety DisordersNCT06076954
Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety
A study testing CoolMinds in people with Anxiety Disorders, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- CoolMinds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2022to 30 Jul 2023
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 12 and 17 years of age
- Primary anxiety diagnosis
- Must have the ability to read and write Danish
- Must have Internet access
- Must have a parent able to participate in the treatment alongside the adolescent
Who cannot join
- Specific phobia of blood-injection-injury type
- An autism spectrum disorder
- Psychotic symptoms
- Bipolar disorder
- Current suicidal ideation or self-mutilating behavior
- Current alcohol or substance abuse
- Moderate to severe depression
- Current eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Feasibility and Acceptability of an Internet-based Cognitive Behavioral (iCBT) Intervention for Adolescents With Anxiety Disorders
The aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. The feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent RCT.
The feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week period. Participants in the guided iCBT condition will receive the new iCBT intervention with planned feedback after each completed module. Participants in the on-demand iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. In both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. Thus, data on engagement will be collected to inform how the two treatment conditions differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where the same measures will be administered as are planned in the RCT.
Read more
Acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. The interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out.
The results from the feasibility trial will be used to inform the subsequent RCT and to revise the intervention, procedures, and conditions if needed.
- Conditions
- Anxiety Disorders
- Being tested
- CoolMinds
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolMindsBehavioural
Also called Internet-based cognitive behavioral therapy, Technology-delivered cognitive behavioral therapy, iCBT
CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.
| Study group | Role | What they receive |
|---|---|---|
| Planned therapist feedback iCBT | Experimental | Participants in the planned therapist feedback iCBT condition will receive the iCBT intervention with planned feedback after each completed module. The therapist may spend a max. of 15 minutes giving feedback per module. Receives: Behavioral: CoolMinds |
| On-demand therapist feedback iCBT | Experimental | Participants in the on-demand therapist feedback iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. The therapist may spend a max. of 15 minutes giving feedback per module. Receives: Behavioral: CoolMinds |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Youth Online Diagnostic Assessment (YODA)
An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias. Each present diagnosis is assigned a clinician-rated severity score ranging from 0 (minimal/absent) to 4 (pervasive). Typically subclinical disorders would receive a rating of 0 or 1, and clinical disorders a rating of 1 to 4.
Measured: Pre-intervention, post-intervention (12 weeks after commencing treatment)
Spence Children's Anxiety Scale (SCAS-C/P)
A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV: generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. Symptoms are rated on a 4-point frequency scale ranging from 0 (never) to 3 (always) (min. = 0; max. = 114). A higher score indicates increased symptom severity. The Danish version has demonstrated good psychometric properties
Measured: Pre-intervention, post-intervention (12 weeks after commencing treatment)
Secondary outcomes (2)
Child Anxiety Life Interference Scale (CALIS)
CALIS measures the impact of youth anxiety on various areas of life functioning such as school, extracurricular activities, family life and friendships. Impact is reported on a 5-point severity scale ranging from 0 (not at all) to 4 (a lot) (min. = 0; max = 56). A summed score of all items is used to indicate level of impact, where a higher score indicates greater impairment. CALIS has shown satisfactory internal consistency and moderate test-retest reliability.
Measured: Pre-intervention, post-intervention (12 weeks after commencing treatment)
The Patient Health Questionnaire (PHQ-9)
A 9-item questionnaire used to measure youth depressive symptoms and suicidal ideation within the past 2 weeks. Symptoms are rated on a frequency scale ranging from 0 (not at all) to 3 (nearly everyday). The symptoms are evaluated independently by adolescents. A summed score of all 9 items is used to indicate symptom severity (min. = 0; max. = 27), where a higher score indicates greater severity and possible presence of a depressive disorder.
Measured: Pre-intervention, post-intervention (12 weeks after commencing treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start15 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Kim Mathiasen, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076954
- Sponsor's protocol ID
- CM1
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorensen NM, Skaarnes H, Mathiasen K, McLellan LF, Thastum M, Lomholt JJ. Internet-based cognitive behavioral therapy (ICBT) for adolescents with anxiety disorders delivered with different types of therapist support: a randomized feasibility trial. Cogn Behav Ther. 2025 Jul 3:1-24. doi: 10.1080/16506073.2025.2522995. Online ahead of print.
PubMed 40607688
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Feasibility and Acceptability of an Internet-based Cognitive Behavioral (iCBT) Intervention for Adolescents With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06076954
- Acronym / sponsor ID
- CM1
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 11 Oct 2023 (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 aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. The feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent RCT.
The feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week period. Participants in the guided iCBT condition will receive the new iCBT intervention with planned feedback after each completed module. Participants in the on-demand iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. In both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. Thus, data on engagement will be collected to inform how the two treatment conditions differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where the same measures will be administered as are planned in the RCT.
Acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. The interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out.
The results from the feasibility trial will be used to inform the subsequent RCT and to revise the intervention, procedures, and conditions if needed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned therapist feedback iCBT | Experimental | Behavioral: CoolMindsParticipants in the planned therapist feedback iCBT condition will receive the iCBT intervention with planned feedback after each completed module. The therapist may spend a max. of 15 minutes giving feedback per module. |
| On-demand therapist feedback iCBT | Experimental | Behavioral: CoolMindsParticipants in the on-demand therapist feedback iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. The therapist may spend a max. of 15 minutes giving feedback per module. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 12 and 17 years of age
- Primary anxiety diagnosis
- Must have the ability to read and write Danish
- Must have Internet access
- Must have a parent able to participate in the treatment alongside the adolescent
Key exclusion criteria (8 listed)
- Specific phobia of blood-injection-injury type
- An autism spectrum 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 |
|---|---|---|
| CoolMindsAlso: Internet-based cognitive behavioral therapy, Technology-delivered cognitive behavioral therapy, iCBTCoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer. | Behavioural | On-demand therapist feedback iCBT, Planned therapist feedback iCBT |
Primary outcome
The Youth Online Diagnostic Assessment (YODA)
Time frame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias. Each present diagnosis is assigned a clinician-rated severity score ranging from 0 (minimal/absent) to 4 (pervasive). Typically subclinical disorders would receive a rating of 0 or 1, and clinical disorders a rating of 1 to 4.
Spence Children's Anxiety Scale (SCAS-C/P)
Time frame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV: generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. Symptoms are rated on a 4-point frequency scale ranging from 0 (never) to 3 (always) (min. = 0; max. = 114). A higher score indicates increased symptom severity. The Danish version has demonstrated good psychometric properties
2 secondary outcomes
Child Anxiety Life Interference Scale (CALIS)
Time frame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
The Patient Health Questionnaire (PHQ-9)
Time frame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 40607688Sorensen NM, Skaarnes H, Mathiasen K, McLellan LF, Thastum M, Lomholt JJ. Internet-based cognitive behavioral therapy (ICBT) for adolescents with anxiety disorders delivered with different types of therapist support: a randomized feasibility trial. Cogn Behav Ther. 2025 Jul 3:1-24. doi: 10.1080/16506073.2025.2522995. Online ahead of print.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
University 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 in people with Anxiety Disorders, run by University of Aarhus 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 8 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: finished, as of the sponsor's last update on 11 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Youth Online Diagnostic Assessment (YODA) (time frame: Pre-intervention, post-intervention (12 weeks after commencing treatment)). 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 NCT06076954, which also lists 1 linked publication.
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 11 Oct 2023.