- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01571089
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)
May 19, 2015 updated by: Sara Edlund, Örebro County Council
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT) - An Alternative for Patients Who Previously Received Exposure-based Treatment for Anxiety Without Sustained Improvements.
The main interest in this study is to investigate if it is possible to use strategies from Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive Behavioral Therapy (CBT) for patients with anxiety disorders.
For the patients included in this study, previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Örebro County
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Hallsberg, Örebro County, Sweden, 694 36
- Psychiatric Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently diagnosed with an anxiety disorder. To be included, the level of anxiety in a critical situation should be high and of a more acute type, unlike the lower more generalized anxiety in for example generalized anxiety disorder.
- Previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).
Exclusion Criteria:
- Severe depression.
- Psychotic disorder.
- A documented neuropsychiatric diagnosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DBT-inspired exposure treatment
DBT-inspired exposure treatment.
|
In short, the treatment is 24 sessions consisting of skills-training strategies and exposure strategies.
The idea is that the patient during the treatment will learn and practice the skills needed to handle exposures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety (Clark, D. M., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., Flower, T., Davenport, C., Louis, B., 2003).
Time Frame: Every day during baseline phase, an expected average of 3 weeks. Everyday during treatment, an expected duration of 24 weeks. Everyday during 6 mo. follow-up, an expected average of 3 weeks.
|
A modified 6-item questionnaire measuring changes in different aspects of anxiety during the day.
Originally developed to measure social anxiety.
|
Every day during baseline phase, an expected average of 3 weeks. Everyday during treatment, an expected duration of 24 weeks. Everyday during 6 mo. follow-up, an expected average of 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Negative Affect Scale (PANAS), (Watson, Clark & Tellegan, 1988).
Time Frame: Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.
|
A 20-item questionnaire measuring positive and negative affect during the past week.
The questionnaire is used to evaluate changes in positive and negative affect.
|
Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.
|
Overall Anxiety Severity and Impairment Scale (OASIS), (Barlow, 2011).
Time Frame: Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.
|
A 5-item questionnaire measuring different aspects of anxiety during the past week.
The questionnaire is used to evaluate changes in anxiety symtoms.
|
Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.
|
Overall Depression Severity and Impairment Scale (ODSIS), (Barlow, 2011).
Time Frame: Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.
|
A 5-item questionnaire measuring different aspects of depression during the past week.
The questionnaire is used to evaluate changes in depressive symtoms.
|
Once a week during baseline phase, an expected average of 3 weeks. Once a week during treatment, an expected duration of 24 weeks. Once a week during 6 mo. follow-up, an expected average of 3 weeks.
|
Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004).
Time Frame: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
|
A 36-item self-report instrument that measure changes in difficulties in emotion regulation.
|
Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
|
Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006).
Time Frame: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
|
A 39-item questionnaire measuring changes in different aspects of mindfulness.
|
Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
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WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004).
Time Frame: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
|
A 26-item self-report instrument that measure changes in quality of life.
|
Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
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Structured Clinical Interview for DSM-IV-I (SCID-I), (First, Spitzer, Gibbon, & Williams, 2001).
Time Frame: Pre- and post treatment
|
A structural interview assessing axis-I disorders.
This instrument is used to evaluate changes in axis-I disorders in the patients.
|
Pre- and post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
April 2, 2012
First Posted (Estimate)
April 4, 2012
Study Record Updates
Last Update Posted (Estimate)
May 20, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OLL-189011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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