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Completed

NCT Number: NCT02978963

CBT for Adolescents With Excessive Worry

This case series aims to test the feasibility and acceptability of streamlined cognitive behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses on reducing intolerance of uncertainty and the hypothesis is that this will help reduce worry.

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Key information

Conditions

Excessive Worry

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 a new form of Cognitive Behavioral Therapy for adolescents with excessive worry. The investigators will include 12 participants with excessive worry and test the treatment which focuses on reducing intolerance of uncertainty (IU) in order to reduce worry.

Participants will be randomized to either one, two or three weeks of weekly baseline measurements prior to starting treatment, and will thus work as their on controls in this case series design.

Primary outcome measures will be collected at 12 weeks after treatment start. Participants will be followed up at three months 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 PSWQ-C of at least 22
  • Age between 13 and 17 years
  • Ability to read and write in Swedish
  • A parent or caregiver that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion criteria

  • Diagnosis of autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
  • Present risk of suicide
  • Ongoing substance dependence
  • 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

Cognitive behavioral therapy

Behavioral

CBT focused on reducing intolerance of uncertainty

Other names: CBT

Primary outcomes

  1. Penn State Worry Questionnaire for Children (PSWQ-C)

    Time frame: At 12 weeks after treatment starts

    Child and parent version

Secondary outcomes

  1. Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

    Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.

    Diagnostic interview

  2. Clinical Global Impression - Severity (CGI-S)

    Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.

    Clinician rated severity of symptoms

  3. Clinical Global Impression - Improvement (CGI-I)

    Time frame: At 12 weeks after start of treatment and three month after treatment has ended.

    Clinician rated improvement after treatment

  4. Children's Global Assessment Scale (CGAS)

    Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.

    Clinician rated global functioning

  5. Brief Intolerance of Uncertainty Scale (Brief IUS)

    Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended

    Self rated tolerance to treatment

  6. Brief Cognitive Avoidance Questionnaire (Brief CAQ)

    Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended

    Self rated cognitive avoidance

  7. Brief Why Worry-II (Brief WW2)

    Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended

    Self rated positive assumptions of worry

  8. Negative Problem Orientation Questionnaire (NPOQ)

    Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended

    Self rated negative problem orientation

  9. Revised Children´s Anxiety and Depression Scale (RCADS-C)

    Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.

    Child and parent version.

  10. Education, Work and Social Adjustment Scale (EWSAS)

    Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.

    Child and parent version.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Cognitive Behavioral Therapy for Adolescents With Excessive Worry - a Case Series

Acronym: BiPOro

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Dec 22, 2017

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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