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)

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) - PROTECT-AD subproject P4

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009687

Enrollment

400

Registered

2015-11-18

Start date

2015-12-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F40.1 F40.2 F40.00 F40.01 F41.0

Interventions

Group 1: Intensified psychological intervention, based on optimized extinction learning (IPI) 12 sessions a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per we

Healthy control group

Two measurement points correspondent to baseline and post-assessment (12 weeks)

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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. 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: 1. Fear extinction paradigm, 2. Emotional reactivity paradigm (face matching task). Additionally a resting state activity and a structural scan will be accessed at Baseline and Post-treatment.	—

Measure

Time frame

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. 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: 1. Fear extinction paradigm, 2. Emotional reactivity paradigm (face matching task). Additionally a resting state activity and a structural scan will be accessed at Baseline and Post-treatment.

—

Secondary

Measure	Time frame
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).	—

Countries

Germany

Contacts

Public ContactKatrin Wambach

Klinische Psychologie und Psychotherapie, Fachbereich Psychologie

wambach@staff.uni-marburg.de+49 (0)6421 282-3681

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026