Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Örebro County Council.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sara Larsson, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01571089
First received: March 26, 2012
Last updated: April 2, 2012
Last verified: April 2012
  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: 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 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A structural interview assessing axis-I disorders. This instrument is used to evaluate changes in axis-I disorders in the patients.


Estimated Enrollment: 8
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571089

Locations
Sweden
Psychiatric Clinic Recruiting
Hallsberg, Örebro County, Sweden, 694 36
Contact: Sara Larsson, Doctoral student    +4619 301266    sara.larsson@oru.se   
Contact: Fredrik Hollandare, PhD    +46737 600700    fredrik.hollandare@orebroll.se   
Principal Investigator: Sara Larsson, Doctoral student         
Sponsors and Collaborators
Örebro County Council
  More Information

No publications provided

Responsible Party: Sara Larsson, Doctoral student & Clinical psychologist, Örebro County Council
ClinicalTrials.gov Identifier: NCT01571089     History of Changes
Other Study ID Numbers: OLL-189011
Study First Received: March 26, 2012
Last Updated: April 2, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 25, 2014