Treatment Resistant Anxiety DisordersNCT01571089
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)
A study testing DBT-inspired anxiety treatment in people with Treatment Resistant Anxiety Disorders, run by Örebro County Council at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Treatment Resistant Anxiety Disorders
- What is being tested?
- DBT-inspired anxiety treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Severe depression.
- Psychotic disorder.
- A documented neuropsychiatric diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Treatment Resistant Anxiety Disorders
- Being tested
- DBT-inspired anxiety treatment
- Keywords
- Dialectical behavior therapy, cognitive behavioral therapy, emotion regulation, emotion dysregulation, anxiety disorders, skills training
- Medical subject headings
- Emotional Regulation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-inspired anxiety treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DBT-inspired exposure treatment | Experimental | DBT-inspired exposure treatment. Receives: Behavioral: DBT-inspired anxiety treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Difficulties in Emotion Regulation Scale (DERS), (Gratz & Roemer, 2004).
A 36-item self-report instrument that measure changes in difficulties in emotion regulation.
Measured: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
Five Fazet Mindfulness Questionnaire (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006).
A 39-item questionnaire measuring changes in different aspects of mindfulness.
Measured: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
WHOQOL-BREF (Skevington, Lofty, O´Connel & WHOQOL Group, 2004).
A 26-item self-report instrument that measure changes in quality of life.
Measured: Five times total. Pre baseline, post baseline/post treatment, after 14 weeks of treatment, post treatment and at 6 mo. follow-up.
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.
Measured: Pre- and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sara Edlund, Örebro County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571089
- Sponsor's protocol ID
- OLL-189011
- Status last verified
- May 2015
- First submitted
- 26 Mar 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01571089
- Acronym / sponsor ID
- OLL-189011
- Conditions
- Treatment Resistant Anxiety Disorders
- Keywords
- Dialectical behavior therapy, cognitive behavioral therapy, emotion regulation, emotion dysregulation, anxiety disorders, skills training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT-inspired exposure treatment | Experimental | Behavioral: DBT-inspired anxiety treatmentDBT-inspired exposure treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Severe depression.
- Psychotic disorder.
- A documented neuropsychiatric diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT-inspired anxiety treatmentIn 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. | Behavioural | DBT-inspired exposure treatment |
Primary outcome
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.
7 secondary outcomes
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.
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.
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.
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.
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.
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.
Structured Clinical Interview for DSM-IV-I (SCID-I), (First, Spitzer, Gibbon, & Williams, 2001).
Time frame: Pre- and post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-inspired anxiety treatment in people with Treatment Resistant Anxiety Disorders, run by Örebro County Council at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.