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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
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 26, 2012
Last Updated
May 19, 2015
Sponsor
Örebro County Council
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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

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Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)

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