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Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Guided-ICBT for adolescents with anxiety
Guided-ICBT with chat
Guided-ICBT with learning support
Guided-ICBT with learning support and chat
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Learning Support, Chat, Adolescents

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linköping University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

ICBT standard

ICBT chat

ICBT learning support

ICBT with learning support and chat

Arm Description

Internet-based cognitive behavioural therapy with therapeutic guidance through mail

Internet-based cognitive behavioural therapy with therapeutic guidance through chat

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail

Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat

Outcomes

Primary Outcome Measures

Beck Anxiety Inventory (BAI)
Measures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Beck Depression Inventory - II (BDI-II)
Measures clinical depression. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

Secondary Outcome Measures

Penn State Worry Questionnaire for Children (PSWQ - C)
Measures 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.
Generalised Anxiety Disorder (GAD-7)
Measures severity of generalised anxiety.
Mini-Social Phobia Inventory (MINI-SPIN)
Measures clinical social phobia. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Agoraphobic Cognitions Questionnaire (ACQ)
Measures 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)
Measures 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.
Rosenberg Self-Esteem Scale (RSES)
Evaluates 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.
Alcohol Use Disorders Identification Test (AUDIT)
Measures 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)
A 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.

Full Information

First Posted
February 14, 2018
Last Updated
August 8, 2018
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT03441490
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
May 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Learning Support, Chat, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICBT standard
Arm Type
Active Comparator
Arm Description
Internet-based cognitive behavioural therapy with therapeutic guidance through mail
Arm Title
ICBT chat
Arm Type
Experimental
Arm Description
Internet-based cognitive behavioural therapy with therapeutic guidance through chat
Arm Title
ICBT learning support
Arm Type
Experimental
Arm Description
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail
Arm Title
ICBT with learning support and chat
Arm Type
Experimental
Arm Description
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat
Intervention Type
Behavioral
Intervention Name(s)
Guided-ICBT for adolescents with anxiety
Intervention Description
Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Guided-ICBT with chat
Intervention Description
Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Guided-ICBT with learning support
Intervention Description
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Guided-ICBT with learning support and chat
Intervention Description
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Description
Measures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Beck Depression Inventory - II (BDI-II)
Description
Measures clinical depression. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Secondary Outcome Measure Information:
Title
Penn State Worry Questionnaire for Children (PSWQ - C)
Description
Measures 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.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Generalised Anxiety Disorder (GAD-7)
Description
Measures severity of generalised anxiety.
Time Frame
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.
Title
Mini-Social Phobia Inventory (MINI-SPIN)
Description
Measures clinical social phobia. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Agoraphobic Cognitions Questionnaire (ACQ)
Description
Measures 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.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Satisfaction With Life Scale (SWLS)
Description
Measures 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.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Rosenberg Self-Esteem Scale (RSES)
Description
Evaluates 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.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Measures alcohol consumption, drinking behaviors, and alcohol-related problems. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Title
Knowledge of CBT strategies (developed by the research group)
Description
A 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.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

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