Clinical trial NCT02605668: Providing Tools for Effective Care and Treatment of Anxiety Disorders
Official title: Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Agoraphobia
Specific Phobias
Social Anxiety Disorder
Keywords: Anxiety Disorders
Extinction Learning
Optimized Extinction
Behavioral Therapy
Massed Confrontation
Social Anxiety Disorder
Specific Phobia
Panic Disorder
Agoraphobia
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
name: University Medicine Greifswald
name: Charite University, Berlin, Germany
name: University of Wuerzburg
name: Philipps University Marburg
name: Wuerzburg University Hospital
name: Universität Münster
First posted: 2015-11-16
Enrollment: 726
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: change in somatic and psychic anxiety symptoms
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)
Secondary outcomes:
measure: change in severity of the anxiety disorder
timeFrame: 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)
measure: change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5)
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in screened anxiety symptoms
timeFrame: 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)
measure: change in depressive symptoms
timeFrame: 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)
measure: change in anxiety sensitivity
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in panic and agoraphobic symptoms
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in agoraphobic avoidance
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in symptoms of Generalized Anxiety Disorder
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in social anxiety
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in Specific Phobia symptoms
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in disability
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in quality of life
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: change in psychopathological symptoms
timeFrame: 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)
measure: change in agoraphobic cognitions
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
measure: fear of body sensations
timeFrame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy
state: Sachsen
Study officials:
affiliation: Technische Universität Dresden
name: Hans-Ulrich Wittchen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heinig I, Pittig A, Richter J, Hummel K, Alt I, Dickhover K, Gamer J, Hollandt M, Koelkebeck K, Maenz A, Tennie S, Totzeck C, Yang Y, Arolt V, Deckert J, Domschke K, Fydrich T, Hamm A, Hoyer J, Kircher T, Lueken U, Margraf J, Neudeck P, Pauli P, Rief W, Schneider S, Straube B, Strohle A, Wittchen HU. Optimizing exposure-based CBT for anxiety disorders via enhanced extinction: Design and methods of a multicentre randomized clinical trial. Int J Methods Psychiatr Res. 2017 Jun;26(2):e1560. doi: 10.1002/mpr.1560. Epub 2017 Mar 21.