Providing Tools for Effective Care and Treatment of Anxiety Disorders (PROTECT-AD)

Technische Universität Dresden

Status

Completed

Conditions

Panic Disorder

Specific Phobias

Social Anxiety Disorder

Agoraphobia

Treatments

Behavioral: Intensified psychological intervention

Behavioral: Standard intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02605668

DRKS00008743 (Registry Identifier)

01EE1402A

Details and patient eligibility

About

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.

Full 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.

Enrollment

726 patients

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 15 - 70 years
one or more of the following DSM-IV/5 anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
HAMA - Score > 18
CGI - Score > 3
Can attend therapy regularly (with or without support)
Informed Consent

Exclusion criteria

Every reason the protocol may not be upheld (e.g. planned hospitalization within study time frame, planning to move away, etc.)
Current suicidal tendency
DSM-5 Bipolar Disorder
DSM-5 Psychotic Disorder
DSM-5 Borderline Personality Disorder
Current treatment of other mental disorder (drugs, psychotherapy)
Current Alcohol, Benzodiazepine or other Substance Use Disorders
Severe medical illness/condition (every serious physical illness, including cardiovascular, kidney, endocrinological and neurological conditions, Hepatitis or other clinical findings that suggest a severe illness and may affect participation in the study)