Clinical trial NCT02978963: CBT for Adolescents With Excessive Worry
Official title: Cognitive Behavioral Therapy for Adolescents With Excessive Worry - a Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Worry
Keywords: Excessive worry
Worry
Adolescents
Intolerance of uncertainty
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2016-12-01
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Penn State Worry Questionnaire for Children (PSWQ-C)
timeFrame: At 12 weeks after treatment starts
Secondary outcomes:
measure: Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
timeFrame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: At 12 weeks after start of treatment and three month after treatment has ended.
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
measure: Brief Intolerance of Uncertainty Scale (Brief IUS)
timeFrame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
measure: Brief Cognitive Avoidance Questionnaire (Brief CAQ)
timeFrame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
measure: Brief Why Worry-II (Brief WW2)
timeFrame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
measure: Negative Problem Orientation Questionnaire (NPOQ)
timeFrame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
measure: Revised Children´s Anxiety and Depression Scale (RCADS-C)
timeFrame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
measure: Education, Work and Social Adjustment Scale (EWSAS)
timeFrame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: