Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)
Primary Purpose
Treatment Resistant Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
DBT-inspired anxiety treatment
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Anxiety Disorders focused on measuring Dialectical behavior therapy, cognitive behavioral therapy, emotion regulation, emotion dysregulation, anxiety disorders, skills training
Eligibility Criteria
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.
Sites / Locations
- Psychiatric Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DBT-inspired exposure treatment
Arm Description
DBT-inspired exposure treatment.
Outcomes
Primary Outcome Measures
Change in anxiety (Clark, D. M., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., Flower, T., Davenport, C., Louis, B., 2003).
A modified 6-item questionnaire measuring changes in different aspects of anxiety during the day. Originally developed to measure social anxiety.
Secondary Outcome Measures
Positive Negative Affect Scale (PANAS), (Watson, Clark & Tellegan, 1988).
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.
Overall Anxiety Severity and Impairment Scale (OASIS), (Barlow, 2011).
A 5-item questionnaire measuring different aspects of anxiety during the past week. The questionnaire is used to evaluate changes in anxiety symtoms.
Overall Depression Severity and Impairment Scale (ODSIS), (Barlow, 2011).
A 5-item questionnaire measuring different aspects of depression during the past week. The questionnaire is used to evaluate changes in depressive symtoms.
Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004).
A 36-item self-report instrument that measure changes in difficulties in emotion regulation.
Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006).
A 39-item questionnaire measuring changes in different aspects of mindfulness.
WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004).
A 26-item self-report instrument that measure changes in quality of life.
Structured Clinical Interview for DSM-IV-I (SCID-I), (First, Spitzer, Gibbon, & Williams, 2001).
A structural interview assessing axis-I disorders. This instrument is used to evaluate changes in axis-I disorders in the patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01571089
Brief Title
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)
Official Title
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT) - An Alternative for Patients Who Previously Received Exposure-based Treatment for Anxiety Without Sustained Improvements.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Anxiety Disorders
Keywords
Dialectical behavior therapy, cognitive behavioral therapy, emotion regulation, emotion dysregulation, anxiety disorders, skills training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DBT-inspired exposure treatment
Arm Type
Experimental
Arm Description
DBT-inspired exposure treatment.
Intervention Type
Behavioral
Intervention Name(s)
DBT-inspired anxiety treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety (Clark, D. M., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., Flower, T., Davenport, C., Louis, B., 2003).
Description
A modified 6-item questionnaire measuring changes in different aspects of anxiety during the day. Originally developed to measure social anxiety.
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.
Secondary Outcome Measure Information:
Title
Positive Negative Affect Scale (PANAS), (Watson, Clark & Tellegan, 1988).
Description
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.
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.
Title
Overall Anxiety Severity and Impairment Scale (OASIS), (Barlow, 2011).
Description
A 5-item questionnaire measuring different aspects of anxiety during the past week. The questionnaire is used to evaluate changes in anxiety symtoms.
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.
Title
Overall Depression Severity and Impairment Scale (ODSIS), (Barlow, 2011).
Description
A 5-item questionnaire measuring different aspects of depression during the past week. The questionnaire is used to evaluate changes in depressive symtoms.
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.
Title
Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004).
Description
A 36-item self-report instrument that measure changes in difficulties in emotion regulation.
Time Frame
Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
Title
Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006).
Description
A 39-item questionnaire measuring changes in different aspects of mindfulness.
Time Frame
Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
Title
WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004).
Description
A 26-item self-report instrument that measure changes in quality of life.
Time Frame
Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
Title
Structured Clinical Interview for DSM-IV-I (SCID-I), (First, Spitzer, Gibbon, & Williams, 2001).
Description
A structural interview assessing axis-I disorders. This instrument is used to evaluate changes in axis-I disorders in the patients.
Time Frame
Pre- and post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Psychiatric Clinic
City
Hallsberg
State/Province
Örebro County
ZIP/Postal Code
694 36
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)
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