Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)

Study Overview
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Brief Summary
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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).

Official Title
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Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT) - An Alternative for Patients Who Previously Received Exposure-based Treatment for Anxiety Without Sustained Improvements.

Conditions
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Treatment Resistant Anxiety Disorders

Intervention / Treatment
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* Behavioral: DBT-inspired anxiety treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBT-inspired exposure treatment<br>DBT-inspired exposure treatment. | Behavioral: DBT-inspired anxiety treatment<br>* 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.<br>|

What is the study measuring?
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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). | 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). | 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). | 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). | 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). | 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). | 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. | 
| WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004). | 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. | 
| 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. | Pre- and post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialectical behavior therapy, cognitive behavioral therapy, emotion regulation, emotion dysregulation, anxiety disorders, skills training