Excessive WorryBiPOroNCT02978963
CBT for Adolescents With Excessive Worry
A study testing Cognitive behavioral therapy in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Excessive Worry
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioral Therapy for Adolescents With Excessive Worry - a Case Series
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.
Read the 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.
- Conditions
- Excessive Worry
- Being tested
- Cognitive behavioral therapy
- Keywords
- Excessive worry, Worry, Adolescents, Intolerance of uncertainty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Also called CBT
CBT focused on reducing intolerance of uncertainty
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | All participants will receive cognitive behavioral therapy for excessive worry. Focus in treatment will be on reducing participants' intolerance uncertainty through in vivo and imaginary exposure to uncertainty inducing situations and thoughts. Treatment will also contain psycho education about anxiety and worry, as well as planning for maintenance of treatment gains. Parents of the participants will receive support and education about worry through an internet-delivered program. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire for Children (PSWQ-C)
Child and parent version
Measured: At 12 weeks after treatment starts
Secondary outcomes (10)
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Diagnostic interview
Measured: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Clinical Global Impression - Severity (CGI-S)
Clinician rated severity of symptoms
Measured: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Clinical Global Impression - Improvement (CGI-I)
Clinician rated improvement after treatment
Measured: At 12 weeks after start of treatment and three month after treatment has ended.
Children's Global Assessment Scale (CGAS)
Clinician rated global functioning
Measured: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Brief Intolerance of Uncertainty Scale (Brief IUS)
Self rated tolerance to treatment
Measured: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Brief Cognitive Avoidance Questionnaire (Brief CAQ)
Self rated cognitive avoidance
Measured: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Brief Why Worry-II (Brief WW2)
Self rated positive assumptions of worry
Measured: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Negative Problem Orientation Questionnaire (NPOQ)
Self rated negative problem orientation
Measured: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Revised Children´s Anxiety and Depression Scale (RCADS-C)
Child and parent version.
Measured: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Education, Work and Social Adjustment Scale (EWSAS)
Child and parent version.
Measured: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive WorryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- Eva Serlachius, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978963
- Sponsor's protocol ID
- EPN DNR 2016/1408-31/5
- Acronym
- BiPOro
- Status last verified
- Dec 2017
- First submitted
- 13 Nov 2016
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Adolescents With Excessive Worry - a Case Series
- ClinicalTrials.gov ID
- NCT02978963
- Acronym / sponsor ID
- BiPOro / EPN DNR 2016/1408-31/5
- Conditions
- Excessive Worry
- Keywords
- Excessive worry, Worry, Adolescents, Intolerance of uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive behavioral therapyAll participants will receive cognitive behavioral therapy for excessive worry. Focus in treatment will be on reducing participants' intolerance uncertainty through in vivo and imaginary exposure to uncertainty inducing situations and thoughts. Treatment will also contain psycho education about anxiety and worry, as well as planning for maintenance of treatment gains. Parents of the participants will receive support and education about worry through an internet-delivered program. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyAlso: CBTCBT focused on reducing intolerance of uncertainty | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Penn State Worry Questionnaire for Children (PSWQ-C)
Time frame: At 12 weeks after treatment starts
Child and parent version
10 secondary outcomes
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.
Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Clinical Global Impression - Improvement (CGI-I)
Time frame: At 12 weeks after start of treatment and three month after treatment has ended.
Children's Global Assessment Scale (CGAS)
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
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
Brief Cognitive Avoidance Questionnaire (Brief CAQ)
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Brief Why Worry-II (Brief WW2)
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Negative Problem Orientation Questionnaire (NPOQ)
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
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.
Education, Work and Social Adjustment Scale (EWSAS)
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Serlachius, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Excessive Worry, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire for Children (PSWQ-C) (time frame: At 12 weeks after treatment starts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.