Providing Tools for Effective Care and Treatment of Anxiety Disorders
Condition: Panic Disorder; Agoraphobia; Specific Phobias; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): Intensified psychological intervention; Standard intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety Disorders; Extinction Learning; Optimized Extinction; Behavioral Therapy; Massed Confrontation; Social Anxiety Disorder; Specific Phobia; Panic Disorder; Agoraphobia