Clinical trial NCT03986827: Cognitive Behavioral Therapy for Adolescents With Social Anxiety Disorder
Official title: A Disorder Specific Group Cognitive Behavior Therapy for Social Anxiety Disorder in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social anxiety disorder
Social phobia
Youth
Cognitive behavioral therapy
Adolescents
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2019-06-14
Enrollment: 96
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled superiority trial comparing two active groups of treatment: 1) Cool Kids Anxiety Program - Social Enhanced (CK-E), 2) Cool Kids Anxiety Program (CK). The study design is a mixed between-within design, with data points pre- and post-treatment, and at 3- and 12-month follow-ups.
Primary purpose: TREATMENT

Brief summary: The main aim of the present study is to investigate the effectiveness of a disorder specific group cognitive behavior therapy (G-CBT) program for youth SAD, the, Cool Kids Anxiety Program - Social Enhanced (CK-E), developed at Macquarie University, Sidney, Australia.

Furthermore, the study will examine how well this program fares against generic CBT treatment.

Detailed description: The main aim of the study is to investigate the effectiveness of a disorder specific G-CBT program for youth SAD compared to a generic G-CBT program for anxiety disorders.

Reduction in anxiety symptoms is expected for both treatment conditions although we hypothesize better outcome for the enhanced treatment condition.

Approximately 96 adolescents aged 12 to 17 years will be included with data points at pre- and post-treatment, and at 3-month and 1-year follow-ups.

Eligibility criteria: Inclusion Criteria:

* Youth between 12 and 17 years of age.
* Social anxiety disorder as the primary disorder measured using the Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P).

Exclusion Criteria:

* A diagnosed autism spectrum disorder (ASD).
* Untreated Attention Deficit Hyperactivity Disorder (ADHD).
* Psychotic symptoms.
* Current severe self-harm or suicidal ideation.
* Current eating disorder.
* CSR\>5 on depression.
* Received prior CK treatment within the last two years.

Primary outcomes:
measure: Change in social anxiety disorder symptoms - measured using Anxiety Disorder Interview Schedule for DSM-IV, Child and Parent Version (ADIS-IV C/P)
timeFrame: Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-up 3-month after session 10.
measure: Change in social anxiety disorder symptoms - measured using The Social Phobia Inventory (SPIN)
timeFrame: Baseline, post-treatment (after session 10 = 10-14 weeks after baseline interview) and follow-ups at 3- month and 1-year after session 10.
measure: Change in social anxiety disorder symptoms - measured using Spence Children's Anxiety Scale (SCAS and SCAS-P)
timeFrame: Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
Secondary outcomes:
measure: The Child Anxiety Life Inference Scale (CALIS)
timeFrame: Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
measure: The Short version of the Mood and Feelings Questionnaire (S-MFQ)
timeFrame: Baseline, post-treatment (10-14 weeks), and 3-month follow-up
measure: The Negative Effects Questionnaire (NEQ)
timeFrame: posttreatment (10-14 weeks)
measure: The Child Health Utility 9D (CHU 9D)
timeFrame: posttreatment (10-14 weeks)
Other outcomes:
measure: Background information
timeFrame: Baseline, post-treatment (10-14 weeks), 3-month follow-up and 1-year follow-up
measure: Credibility/expectation questionnaire (CEQ )
timeFrame: CEQ will be completed after session 1 (week one)
measure: Experience of Service Questionnaire (ESQ)
timeFrame: posttreatment (10-14 weeks)
measure: Depression Anxiety Stress Scales (DASS)
timeFrame: Baseline, post-treatment (10-14 weeks), 3-month follow-up
measure: Mini-SPIN
timeFrame: In the current study mini-SPIN will be used as a severity measure rated by the adolescents prior to session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
measure: Postevent version of the Thoughts Questionnaire (PTQ)
timeFrame: Assessed after session session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
measure: Focus of Attention Questionnaire (FAQ)
timeFrame: Adolescents complete FAQ after session session 1 (week one), 4 (week four), 7 (week seven) and 10 (week 10-14)
measure: Subtle Avoidance Frequency Examination (SAFE)
timeFrame: Baseline, post-treatment (10-14 weeks), 3-month follow-up
measure: The Children's Automatic Thoughts Scale (CATS)
timeFrame: Baseline, post-treatment (10-14 weeks), 3-month follow-up
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Psychology and Behavioural Sciences
Study officials:
affiliation: University of Aarhus
name: Mikael Thastum, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lassen NF, Hougaard E, Arendt KB, Thastum M. A disorder-specific group cognitive behavior therapy for social anxiety disorder in adolescents: study protocol for a randomized controlled study. Trials. 2019 Dec 21;20(1):757. doi: 10.1186/s13063-019-3885-3.