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Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441490
Enrollment
120
Registered
2018-02-22
Start date
2018-02-08
Completion date
2018-06-20
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Learning Support, Chat, Adolescents

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.

Interventions

BEHAVIORALGuided-ICBT for adolescents with anxiety

Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.

BEHAVIORALGuided-ICBT with chat

Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.

BEHAVIORALGuided-ICBT with learning support

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.

BEHAVIORALGuided-ICBT with learning support and chat

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Beck Anxiety Inventory (BAI)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Beck Depression Inventory - II (BDI-II)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures clinical depression. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

Secondary

MeasureTime frameDescription
Mini-Social Phobia Inventory (MINI-SPIN)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures clinical social phobia. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Agoraphobic Cognitions Questionnaire (ACQ)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures fearful cognitions associated with panic attacks and agoraphobia. The ACQ consists of 14 items which will be scored as a total scale in this study. worry. Respondents rates each item on a 5-point Likert scale consisting of never (1), Thought never occurs (2), Thought rarely occurs (3) Thought occurs during half of the times when I am nervous (4) Thought usually occurs (5) Thought always occurs when I am nervous. ACQ can be divided into two subscales: Loss of Control and Physical Concerns. Each of the subscales consists of 7 items.The total scores (or the subscales) are calculated by averaging the responses to the individual items composing that score. Higher scores indicates higher levels of fearful cognitions. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Satisfaction With Life Scale (SWLS)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures global cognitive judgements of one's life satisfacation as a whole, on a 5-item scale. Respondants rates how much they agree or disagree on a 7-pont scale ranging from (7) strongly agree to (1) strongly disagree, where higher scores indicates higher levels of life satisfaction. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Penn State Worry Questionnaire for Children (PSWQ - C)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures the tendency of youth to engage in excessive, generalized and uncontrollable worry. Respondents rates each item on a 4-point Likert scale consisting of never (0), sometimes (1), often (2) and always (3). The scores from each item are summed together to yield a total score that ranges from 0-42, with higher scores reflecting higher levels of worry. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Alcohol Use Disorders Identification Test (AUDIT)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentMeasures alcohol consumption, drinking behaviors, and alcohol-related problems. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Knowledge of CBT strategies (developed by the research group)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentA brief 16-item questionnaire that measures explicit, declarative knowledge about core CBT-principles and therapeutic points. Higher scores indicates more knowledge. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Rosenberg Self-Esteem Scale (RSES)Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatmentEvaluates individual self-esteem. The scale is a ten item Likert scale with items answered on a four point scale, from (0) strongly agree to strongly disagree (3), where higher scores indicates higher self-esteem. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Generalised Anxiety Disorder (GAD-7)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.Measures severity of generalised anxiety.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026