Clinical Trial: Providing Tools for Effective Care and Treatment of Anxiety Disorders
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction
Brief Summary:
PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities.
It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. In order to achieve this, the investigators want to investigate the effect of extinction learning in an "intensified" psychological intervention on treatment outcome in adults and children with anxiety disorders.
The intensified psychological intervention is characterized by a higher number of exposure trials over a short time period. In the control condition the exposure trials take place in a weekly interval, analog to standard care.
Detailed Summary: Novel preclinical research evidence suggests extinction learning as the core mechanism of action of exposure-based therapies and provides according strategies to improve the effectiveness of treatment by optimized extinction. A translational research agenda is suggested to examine whether enhanced extinction learning components derived from preclinical research, applied within an "intensified" exposure-based treatment, improves outcomes. In a multicenter randomized clinical trial, linked to mechanistic subprojects, the investigators test in n=620 patients with primary AD allowing for comorbidity whether intensified psychological interventions based on augmented extinction learning (IPI) result in faster, stronger and more persistent outcomes on subjective, clinical, behavioral, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). The investigators hypothesize that (a) enhanced extinction elements (IPI) will result in higher effect sizes, faster recovery, (b) more pronounced changes in an array of systems, including elements of extinction learning and in objective behavioral measures assessed in intersession exposure trials. The investigators also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.
Sponsor: Technische Universität Dresden
Current Primary Outcome: change in somatic and psychic anxiety symptoms [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change in severity of the anxiety disorder [ Time Frame: assessed five times: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]Severity of the anxiety disorder is assessed by the clinician-rated Clinical Global Impression Scale (CGI). It is anchored for anxiety disorders.
- change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5) [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]categorical diagnoses are assessed using a German version of the Composite International Diagnostic Interview (CIDI).
- change in screened anxiety symptoms [ Time Frame: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]The DSM-5 cross-cutting symptom measure for anxiety disorders ("Cross-D") is used as a brief screener for anxiety symptoms.
- change in depressive symptoms [ Time Frame: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]depressive symptoms are assessed using the Beck Depression Inventory (BDI-II)
- change in anxiety sensitivity [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]anxiety sensitivity is assessed using the Anxiety sensitivity inventory (ASI)
- change in panic and agoraphobic symptoms [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]panic and agoraphobic symptoms are assessed using the Panic and agoraphobia scale (PAS)
- change in agoraphobic avoidance [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]agoraphobic avoidance is assessed using the Mobility Inventory (MI)
- change in symptoms of Generalized Anxiety Disorder [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]symptoms of generalized anxiety disorder (GAD)are assessed using the GAD-7
- change in social anxiety [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]social anxiety is assessed using the Liebowitz Social Anxiety Scale (LSAS)
- change in Specific Phobia symptoms [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]symptoms of specific phobia are assessed using an adapted version of the DSM-5 dimensional scale for specific phobias
- change in disability [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]Disability is assessed using the 12-item version of the World Health Organization Disability Schedule (WHODAS 2.0)
- change in quality of life [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]Quality of life is assessed using the EuroQol five-dimensional measure for quality of life (EQ5D)
- change in psychopathological symptoms [ Time Frame: assessed seven times: Baseline, therapy sessions 2 (week 1 of therapy), 4 (week 2), 7 (week 3 to 5), 10 (week 4 to 8), 11 (week 5 to 9), 12 (week 6 to 10) Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]psychopathological symptoms are assessed using the Brief Symptom Inventory (BSI), a short form of the Symptom Checklist 90 (SCL-90). At Baseline, Post and Follow Up, the 53 item Version is used, during therapy the 18 item version is used
- change in agoraphobic cognitions [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]agoraphobic cognitions are assessed using the Agoraphobic Cognitions Questionnaire (ACQ)
- fear of body sensations [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]Same as current
Information By: Technische Universität Dresden
Dates:
Date Received: August 24, 2015
Date Started: January 2016
Date Completion: January 2019
Last Updated: August 2, 2016
Last Verified: August 2016
