Skip to main content
OpenTrials
Completed

NCT Number: NCT01571089

Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Treatment Resistant Anxiety Disorders Anxiety Disorders Behavior Emotional Regulation Mental Disorders Self-Control Social Behavior

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Clinic

Hallsberg, Örebro County, 694 36, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBT-inspired anxiety treatment

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2012
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.