An interventional study of Intensified psychological intervention and Standard intervention in Panic Disorder, Agoraphobia and Specific Phobias, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Intensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning
Behavioral: Intensified psychological intervention
Standard intervention (Cognitive Behavioral Therapy) without optimized extinction learning
Behavioral: Standard intervention
12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6)
12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10)
change in somatic and psychic anxiety symptoms
Anxiety symptoms are assessed using the clinician-rated Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A for the HAMA). Stronger, faster and more persistent reduction of anxiety symptoms in the IPI group than in the TAU group is expected.
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)
change in severity of the anxiety disorder
Severity of the anxiety disorder is assessed by the clinician-rated Clinical Global Impression Scale (CGI). It is anchored for anxiety disorders.
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)
change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5)
categorical diagnoses are assessed using a German version of the Composite International Diagnostic Interview (CIDI).
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in screened anxiety symptoms
The DSM-5 cross-cutting symptom measure for anxiety disorders ("Cross-D") is used as a brief screener for 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)
change in depressive symptoms
depressive symptoms are assessed using the Beck Depression Inventory (BDI-II)
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)
change in anxiety sensitivity
anxiety sensitivity is assessed using the Anxiety sensitivity inventory (ASI)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in panic and agoraphobic symptoms
panic and agoraphobic symptoms are assessed using the Panic and agoraphobia scale (PAS)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in agoraphobic avoidance
agoraphobic avoidance is assessed using the Mobility Inventory (MI)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in symptoms of Generalized Anxiety Disorder
symptoms of generalized anxiety disorder (GAD)are assessed using the GAD-7
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in social anxiety
social anxiety is assessed using the Liebowitz Social Anxiety Scale (LSAS)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in Specific Phobia symptoms
symptoms of specific phobia are assessed using an adapted version of the DSM-5 dimensional scale for specific phobias
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in disability
Disability is assessed using the 12-item version of the World Health Organization Disability Schedule (WHODAS 2.0)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in quality of life
Quality of life is assessed using the EuroQol five-dimensional measure for quality of life (EQ5D)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in psychopathological symptoms
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
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)
change in agoraphobic cognitions
agoraphobic cognitions are assessed using the Agoraphobic Cognitions Questionnaire (ACQ)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
fear of body sensations
fear of body sensations is assessed using the Body Sensations Questionnaire (BSQ)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
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Technische Universität Dresden