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Completed

NCT Number: NCT03469453

Internet-delivered CBT for Adolescents With GAD

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).

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet-delivered cognitive behavioral therapy

Behavioral

Therapist-supported CBT delivered online.

Other names: ICBT

Primary outcomes

  1. Brief Penn State Worry Questionnaire for Children

    Time frame: 10 weeks after baseline

    Self-assessment of excessive worry for individual analysis in multiple baseline evaluation

  2. Penn State Worry Questionnaire for Children

    Time frame: 10, 14 and 22 weeks after baseline

    Child and parent version, lower values indicating decrease in worry. Assessments used in group statistical analysis of clinical outcome

Secondary outcomes

  1. Brief Intolerance of Uncertainty Scale

    Time frame: 10, 14 and 22 weeks after baseline

    Child version, lower values indicating decrease in intolerance of uncertainty

  2. Brief Cognitive Avoidance Questionnaire

    Time frame: 10, 14 and 22 weeks after baseline

    Child version, lower values indicating decrease in cognitive avoidance

  3. Negative Problem Orientation Questionnaire, abbreviated

    Time frame: 10, 14 and 22 weeks after baseline

    Child version, lower values indicating decrease in negative problem orientation

  4. Revised Children's Anxiety and Depression Scale

    Time frame: 10, 14 and 22 weeks after baseline

    Child and parent versions, lower values indicating decrease in anxiety and depression

  5. Education, Work and Social Adjustment Scale

    Time frame: 10 and 22 weeks after baseline

    Child and parent versions, , lower values indicating decreased impairment due to worry

  6. Clinical Global Impression - Improvement

    Time frame: 10, 14 and 22 weeks after baseline

    Clinician rated, higher values indicate larger improvement after treatment

  7. Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV

    Time frame: 10, 14 and 22 weeks after baseline

    Diagnostic interview

  8. Clinician Severity Rating

    Time frame: 10, 14 and 22 weeks after baseline

    Clinician rated severity with lower values indicating lower level of severity of a disorder

  9. Children's Global Assessment Scale

    Time frame: 10, 14 and 22 weeks after baseline

    Clinician rated global functioning, higher values indicate higher functioning

Other outcomes

  1. Treatment credibility and expectancy scale (child and parent version)

    Time frame: 10 weeks after baseline

    A 5-item scale, rated from 0-10, with higher scores indicating higher treatment credibility and expectancy.

  2. Negative Events Questionnaire (child and parent version)

    Time frame: 10 weeks after baseline

    The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention.

  3. Client satisfaction questionnaire

    Time frame: 10 weeks after baseline

    Child- and parent rated treatment satisfaction is rated on an eight items scale,ange 0-3, with higher score indicating higher satisfaction..

  4. Internet intervention Patient Adherence Scale

    Time frame: 5 and 10 weeks after baseline

    Clinician rated, 5-item scale ranging from 0-4 with higher scores indicating higher participant adherence to treatment.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

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

Acronym: BIPWorry

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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