Providing Tools for Effective Care and Treatment of Anxiety Disorders

Panic Disorder Clinical Trial

— PROTECT-AD  

Official title:

Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605668
• Other study ID #: 01EE1402A
• Secondary ID: DRKS00008743
• Status: Completed
• Phase: N/A
• Start date: December 12, 2015
• Est. completion date: July 24, 2019

Study information

• Verified date: September 2019
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 726
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Disease
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder
• Specific Phobias

Intervention

Behavioral:
• Intensified psychological 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)
• Standard intervention
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)

Locations

Country	Name	City	State
Germany	Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy	Dresden	Sachsen

Sponsors (8)

Lead Sponsor	Collaborator
Technische Universität Dresden	Charite University, Berlin, Germany, Philipps University Marburg Medical Center, Ruhr University of Bochum, University Medicine Greifswald, University of Wuerzburg, Westfälische Wilhelms-Universität Münster, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Heinig I, Pittig A, Richter J, Hummel K, Alt I, Dickhöver 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, Ströhle 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). doi: 10.1002/mpr.1560. Epub 2017 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)
Secondary	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.	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)
Secondary	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).	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	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.	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)
Secondary	change in depressive symptoms	depressive symptoms are assessed using the Beck Depression Inventory (BDI-II)	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)
Secondary	change in anxiety sensitivity	anxiety sensitivity is assessed using the Anxiety sensitivity inventory (ASI)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in panic and agoraphobic symptoms	panic and agoraphobic symptoms are assessed using the Panic and agoraphobia scale (PAS)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in agoraphobic avoidance	agoraphobic avoidance is assessed using the Mobility Inventory (MI)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in symptoms of Generalized Anxiety Disorder	symptoms of generalized anxiety disorder (GAD)are assessed using the GAD-7	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in social anxiety	social anxiety is assessed using the Liebowitz Social Anxiety Scale (LSAS)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in Specific Phobia symptoms	symptoms of specific phobia are assessed using an adapted version of the DSM-5 dimensional scale for specific phobias	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in disability	Disability is assessed using the 12-item version of the World Health Organization Disability Schedule (WHODAS 2.0)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	change in quality of life	Quality of life is assessed using the EuroQol five-dimensional measure for quality of life (EQ5D)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	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	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)
Secondary	change in agoraphobic cognitions	agoraphobic cognitions are assessed using the Agoraphobic Cognitions Questionnaire (ACQ)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Secondary	fear of body sensations	fear of body sensations is assessed using the Body Sensations Questionnaire (BSQ)	assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)