Clinical trial NCT03441490: Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
Official title: Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Learning Support
Chat
Adolescents
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2018-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Design is a two-by-two factorial randomized trial with four intervention groups: 1, ICBT with therapeutic guidance through mail. 2, ICBT with therapeutic guidance through chat. 3, ICBT with learning support and terapeutic guidance through mail. 4. ICBT with learning support and terapeutic guidance through chat.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of learning support and chat on treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for adolescents with anxiety.

Detailed description: The study is set up as a factorial design with two independent variables: 1: Learning support and 2: chat-sessions in real time. The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform. Participants in the study are recruited from the general public via social media. The intervention is in Swedish.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 15-19 years old
* Have symptoms of anxiety, anxiety disorder

Exclusion Criteria:

* Suicidal ideation
* Alcohol addiction
* other major primary psychiatric disorder
* Ongoing psychological treatment
* recent (during last 4 weeks) change in psychiatric medication

Primary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Secondary outcomes:
measure: Penn State Worry Questionnaire for Children (PSWQ - C)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Generalised Anxiety Disorder (GAD-7)
timeFrame: First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.
measure: Mini-Social Phobia Inventory (MINI-SPIN)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
measure: Knowledge of CBT strategies (developed by the research group)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: