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Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571089
First Posted: April 4, 2012
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sara Edlund, Örebro County Council
  Purpose
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).

Condition Intervention
Treatment Resistant Anxiety Disorders Behavioral: DBT-inspired anxiety treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sara Edlund, Örebro County Council:

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). [ 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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 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.

  • 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.

  • 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.


Enrollment: 5
Study Start Date: March 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBT-inspired exposure treatment
DBT-inspired exposure treatment.
Behavioral: DBT-inspired anxiety 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571089


Locations
Sweden
Psychiatric Clinic
Hallsberg, Örebro County, Sweden, 694 36
Sponsors and Collaborators
Örebro County Council
  More Information

Responsible Party: Sara Edlund, Doctoral student & Clinical psychologist, Örebro County Council
ClinicalTrials.gov Identifier: NCT01571089     History of Changes
Other Study ID Numbers: OLL-189011
First Submitted: March 26, 2012
First Posted: April 4, 2012
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Sara Edlund, Örebro County Council:
Dialectical behavior therapy
cognitive behavioral therapy
emotion regulation
emotion dysregulation
anxiety disorders
skills training

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders


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