Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety

Anxiety Disorders Clinical Trial

Official title:

Development, Feasibility and Acceptability of an Internet-based Cognitive Behavioral (iCBT) Intervention for Adolescents With Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06076954
• Other study ID #: CM1
• Status: Completed
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: September 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• CoolMinds
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.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Region Of Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire-8 (CSQ-8)	An 8-item questionnaire used to measure general satisfaction with a received treatment. Satisfaction is reported using a 4-point scale ranging from 1 (lowest degree of satisfaction) to 4 (highest degree of satisfaction). A summed score of all items is used to indicate level of satisfaction (min = 8; max. = 32). The scale has shown high internal consistency and concurrent validity.	Post-intervention (12 weeks after commencing treatment)
Other	EuroQol-5 Dimension Youth (EQ-5D-5L)	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. Each domain is assigned a score from 1 (no health problems) to 3 (a lot of health problems) and based on these scores, a unique health state can be identified for each participant.	Pre-intervention, post-intervention (12 weeks after commencing treatment)
Other	Negative Effects Questionnaire (NEQ)	A 20-item questionnaire used to monitor the occurrence of negative effects in psychological treatments. Participants are asked to report whether specific things have occurred or not during treatment, how negatively it affected them, and whether the negative affect is attributed to the received treatment or other circumstances. The items can be summed together in order to get a frequency measure of the number of negative effects the respondents have experienced, divided by treatment or other circumstances. NEQ shows acceptable psychometric properties.	Post-intervention (12 weeks after commencing treatment)
Other	Systems Usability Scale (SUS)	A 10-item questionnaire used to assess the subjective experience of usability of a computer system. Participants are asked to score 10 different statements about the computer system on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree). A higher summed score indicates greater comfortability with the computer system. A Danish version of the SUS has been validated in a mental health care setting.	Post-intervention (12 weeks after commencing treatment)
Other	Engagement with the program: Wordcount	Number of words in the in-program text modules and number of words in messages sent by both participant and therapist.	Post-intervention (12 weeks after commencing treatment)
Other	Engagement with the program: number of logins	Number of logins in the digital platform.	Post-intervention (12 weeks after commencing treatment)
Other	Engagement with the program: Time spent on feedback	Therapist time spent giving feedback reported in minutes.	Post-intervention (12 weeks after commencing treatment)
Other	Demography	Sociodemographic measures include participants' age and gender, and parents' level of education, and primary caregiver in case of single parents.	Pre-intervention
Primary	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.	Pre-intervention, post-intervention (12 weeks after commencing treatment)
Primary	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	Pre-intervention, post-intervention (12 weeks after commencing treatment)
Secondary	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.	Pre-intervention, post-intervention (12 weeks after commencing treatment)
Secondary	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.	Pre-intervention, post-intervention (12 weeks after commencing treatment)