Clinical trial NCT01571089: 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
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Anxiety Disorders
Keywords: Dialectical behavior therapy
cognitive behavioral therapy
emotion regulation
emotion dysregulation
anxiety disorders
skills training
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2012-04-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in anxiety (Clark, D. M., Ehlers, A., McManus, F., Hackmann, A., Fennell, M., Campbell, H., Flower, T., Davenport, C., Louis, B., 2003).
timeFrame: 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 outcomes:
measure: Positive Negative Affect Scale (PANAS), (Watson, Clark & Tellegan, 1988).
timeFrame: 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.
measure: Overall Anxiety Severity and Impairment Scale (OASIS), (Barlow, 2011).
timeFrame: 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.
measure: Overall Depression Severity and Impairment Scale (ODSIS), (Barlow, 2011).
timeFrame: 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.
measure: Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004).
timeFrame: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
measure: Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006).
timeFrame: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
measure: WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004).
timeFrame: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
measure: Structured Clinical Interview for DSM-IV-I (SCID-I), (First, Spitzer, Gibbon, & Williams, 2001).
timeFrame: Pre- and post treatment
Other outcomes:
Locations:
city: Hallsberg
country: Sweden
facility: Psychiatric Clinic
state: Örebro County
Study officials:
References: