Treatment Resistant Anxiety Disorders Clinical Trial
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.
| Verified date | May 2015 |
| Source | Örebro County Council |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Psychiatric Clinic | Hallsberg | Örebro County |
| Lead Sponsor | Collaborator |
|---|---|
| Örebro County Council |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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. | No |
| Secondary | 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. | 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. | No |
| Secondary | 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. | 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. | No |
| Secondary | 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. | 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. | No |
| Secondary | Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004). | A 36-item self-report instrument that measure changes in difficulties in emotion regulation. | Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up. | No |
| Secondary | Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). | A 39-item questionnaire measuring changes in different aspects of mindfulness. | Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up. | No |
| Secondary | WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004). | A 26-item self-report instrument that measure changes in quality of life. | Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up. | No |
| Secondary | 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. | Pre- and post treatment | No |