Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction Learning (MRI subproject P4: Neural response and Fear Circuitry Activity Related to Extinction Learning and Outcome)

Not Applicable

• Conditions: F40.1; F40.2; F40.00; F40.01; F41.0; Social phobias; Specific (isolated) phobias; Panic disorder [episodic paroxysmal anxiety]

• Registration Number: DRKS00009687
• Lead Sponsor: Technische Universität Dresden, Institut für Klinische Psychologie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-18
• Study Completion: 2019-07-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

• on or more of the following DSM-V Anxiety Disorders: Panic disorder, Agoraphobia, Social
Anxiety Disorder, Specific Phobia
• HAMA – Score = 18
• CGI – Score = 3
• Can attend Therapie regularly (with or without suppot)
• Informed Consent

• Healthy control group: • No DSM-5 Diagnosis • 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-V Bipolar Disorder
• DSM-V Psychotic Disorder
• DSM-V Borderline PD
• 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)
• Pregnancy
• MRI exclusion criteria (e.g., metal in body)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROTECT-AD: Stronger reduction of anxiety symptoms in the IPI group than in the TAU group, Anxiety symptoms are assessed using the HAM-A at Baseline, Post/after session twelve and Follow up/after six months.<br><br>PROTECT-AD subproject P4: Stronger changes in neural activation (measured using functional magnetic resonance imaging; fMRI) of fear network regions (amygdala, hippocampus, ACC, insula) in the IPI group than in the TAU group from Baseline to Post/after session twelve. The following experimental fMRI paradigms will be applied: <br>1. Fear extinction paradigm,<br>2. Emotional reactivity paradigm (face matching task).<br><br>Additionally a resting state activity and a structural scan will be accessed at Baseline and Post-treatment.

Secondary Outcome Measures

Name	Time	Method
Consideration of whole brain data, functional connectivity (predominantly ACC and amygdala) and brain structure (T1). Consideration of behavioural, physiological and clinical measures of PROTECT-AD (DRKS00008743).