Internet-delivered CBT for Adolescents With GAD

Generalized Anxiety Disorder Clinical Trial

— BIPWorry  

Official title:

Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469453
• Other study ID #: EPN DNR 2017/1879-31/5
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: May 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD).

Description:

This pilot study aims to test Internet-delivered Cognitive Behavioral Therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD)

The study has a single case research design (multiple baseline) and will include 12 participants with GAD according to a semi structured diagnostic interview.

Participants will be randomized to either two, six or ten weeks baseline measurements prior to starting treatment, and will thus work as their own controls.

Primary outcome measures will be collected at 10 weeks after treatment start. Follow-up assessments will be made three month after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• A score on the Penn State Worry Questionnaire for Children (PSWQ-C) of > 30

• Fulfilling DSM-5 criteria for Generalized Anxiety Disorder

• No other disorder or symptoms present in need of more urgent treatment

• Aged between 13 and 17 years

• Ability to read and write in Swedish

• A parent or caregiver that is able to participate in the treatment

• Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

• No other ongoing psychological treatment for any disorder

Exclusion Criteria:

• The presence of symptoms suggestive of a current diagnosis of Autistic Spectrum Disorder, Schizophrenia, Bipolar Disorder, Anorexia Nervosa, Bulimia, or Substance Use Disorder

• Present risk of suicide

• Present occurrence of domestic violence

• Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Internet-Delivered Cognitive Behavioral Therapy
Therapist-supported CBT delivered online.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment credibility and expectancy scale (child and parent version)	A 5-item scale, rated from 0-10, with higher scores indicating higher treatment credibility and expectancy.	10 weeks after baseline
Other	Negative Events Questionnaire (child and parent version)	The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention.	10 weeks after baseline
Other	Client satisfaction questionnaire	Child- and parent rated treatment satisfaction is rated on an eight items scale,ange 0-3, with higher score indicating higher satisfaction..	10 weeks after baseline
Other	Internet intervention Patient Adherence Scale	Clinician rated, 5-item scale ranging from 0-4 with higher scores indicating higher participant adherence to treatment.	5 and 10 weeks after baseline
Primary	Brief Penn State Worry Questionnaire for Children	Self-assessment of excessive worry for individual analysis in multiple baseline evaluation	10 weeks after baseline
Primary	Penn State Worry Questionnaire for Children	Child and parent version, lower values indicating decrease in worry. Assessments used in group statistical analysis of clinical outcome	10, 14 and 22 weeks after baseline
Secondary	Brief Intolerance of Uncertainty Scale	Child version, lower values indicating decrease in intolerance of uncertainty	10, 14 and 22 weeks after baseline
Secondary	Brief Cognitive Avoidance Questionnaire	Child version, lower values indicating decrease in cognitive avoidance	10, 14 and 22 weeks after baseline
Secondary	Negative Problem Orientation Questionnaire, abbreviated	Child version, lower values indicating decrease in negative problem orientation	10, 14 and 22 weeks after baseline
Secondary	Revised Children's Anxiety and Depression Scale	Child and parent versions, lower values indicating decrease in anxiety and depression	10, 14 and 22 weeks after baseline
Secondary	Education, Work and Social Adjustment Scale	Child and parent versions, , lower values indicating decreased impairment due to worry	10 and 22 weeks after baseline
Secondary	Clinical Global Impression - Improvement	Clinician rated, higher values indicate larger improvement after treatment	10, 14 and 22 weeks after baseline
Secondary	Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV	Diagnostic interview	10, 14 and 22 weeks after baseline
Secondary	Clinician Severity Rating	Clinician rated severity with lower values indicating lower level of severity of a disorder	10, 14 and 22 weeks after baseline
Secondary	Children's Global Assessment Scale	Clinician rated global functioning, higher values indicate higher functioning	10, 14 and 22 weeks after baseline