Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Dr Hans-Ulrich Wittchen (PI) / Mr Thomas Lang


Contact details

Technische Universität Dresden
Institute for Clinical Psychology and Psychotherapy
Chemnitzer Str. 46
+49 (0)351 463 369 72

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Cognitive Behavioural Therapy (CBT) is effective in the psychological treatment of Panic Disorder (PD) and Agoraphobia (AG). However, CBT refers to a heterogeneous group of interventions, including psychoeducation, cognitive restructuring and exposure. The main active ingredients of CBT for panic disorder are yet not determined. Although exposure components appear essential to effective treatment of PD/AG, the debate related to the duration and format of exposure persist.

The current study compares two formats of a manualised CBT for panic disorder that differ only in the implementation of exposure therapy:
1. CbT refers to an exposure homework (only) condition; the therapist only assigns exposure.
2. cBT refers to exposure that is therapist-guided; the therapist will accompany the patients in the exposure situation.

Hypotheses are:
1. Both Cognitive Behavioural Therapy (CBT) groups will be significantly superior to the wait-list control group in all primary outcome measures.
2. The “in-vivo-cBT" group will be significantly better than the “only-CbT” group at post-treatment and at follow-up.

Ethics approval

The study was approved by the Ethics Committee of the Medical Faculty, Technical University Dresden on the 1st December 2006 (ref: EK 164082006).

Study design

Randomised clinical trial, intervention study with two active arms and a wait-list control group

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Panic disorder with and without agoraphobia


Two treatment conditions are compared, both of them state-of-the-art-CBT:
Condition A: CBT for panic disorder with therapist-guided in-vivo exposure exercises (in-vivo cBT-group)
Condition B: CBT for panic disorder with exposure elements as an homework assignment, only (only-CbT group)

Intervention type



Not Specified

Drug names

Primary outcome measures

1. Number of panic attacks/month
2. Aggregated Panic Disorder Scale and Mobility Inventory (PDS-MI) score (panic severity plus avoidance)
3. Hamilton Anxiety Rating Scale

Secondary outcome measures

1. Depressive symptoms
2. Anticipatory anxiety in dark room-challenge and time in darkroom
3. Psychophysiological parameters
4. Neuroimaging parameters
5. Ecological Momentary Assessment (EMA) parameters

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Outpatients
2. 18 to 65 years old
3. Meet current Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria of panic disorder with/without agoraphobia
4. Hamilton Anxiety Scale (HAMA) score more than or equal to 18 and a Clinical Global Impressions scale (CGI) score more than or equal to four
5. Able to attend clinic on his/her own or accompanied by significant others
6. Informed consent to participate and follow study procedures

Participant type


Age group



Not Specified

Target number of participants

450 (375 completers)

Participant exclusion criteria

1. DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II of borderline personality disorder
2. DSM-IV Axis I disorders (other than panic disorder and agoraphobia) currently treated either by medications or non-pharmacological intervention
3. Acute suicidality (Composite International Diagnostic Interview [CIDI] scale 2+)
4. General medical contraindications

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Technische Universität Dresden

Sponsor information


German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)

Sponsor details

Heinrich-Konen-Str. 1
+49 (0)228 3821 118

Sponsor type




Funder type


Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GV0615)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in
2. 2011 results in
3. 2012 additional results regarding the impact of depression on CBT in
4. 2013 results in

Publication citations

  1. Protocol

    Gloster AT, Wittchen HU, Einsle F, Höfler M, Lang T, Helbig-Lang S, Fydrich T, Fehm L, Hamm AO, Richter J, Alpers GW, Gerlach AL, Ströhle A, Kircher T, Deckert J, Zwanzger P, Arolt V, Mechanism of action in CBT (MAC): methods of a multi-center randomized controlled trial in 369 patients with panic disorder and agoraphobia., Eur Arch Psychiatry Clin Neurosci, 2009, 259 Suppl 2, S155-66, doi: 10.1007/s00406-009-0065-6.

  2. Results

    Gloster AT, Wittchen HU, Einsle F, Lang T, Helbig-Lang S, Fydrich T, Fehm L, Hamm AO, Richter J, Alpers GW, Alpers GW, Gerlach AL, Ströhle A, Kircher T, Deckert J, Zwanzger P, Höfler M, Arolt V, Psychological treatment for panic disorder with agoraphobia: a randomized controlled trial to examine the role of therapist-guided exposure in situ in CBT., J Consult Clin Psychol, 2011, 79, 3, 406-420, doi: 10.1037/a0023584.

  3. Additional results regarding the impact of depression on CBT

    Emmrich A, Beesdo-Baum K, Gloster AT, Knappe S, Höfler M, Arolt V, Deckert J, Gerlach AL, Hamm A, Kircher T, Lang T, Richter J, Ströhle A, Zwanzger P, Wittchen HU, Depression does not affect the treatment outcome of CBT for panic and agoraphobia: results from a multicenter randomized trial., Psychother Psychosom, 2012, 81, 3, 161-172, doi: 10.1159/000335246.

  4. Results

    Kircher T, Arolt V, Jansen A, Pyka M, Reinhardt I, Kellermann T, Konrad C, Lueken U, Gloster AT, Gerlach AL, Ströhle A, Wittmann A, Pfleiderer B, Wittchen HU, Straube B, Effect of cognitive-behavioral therapy on neural correlates of fear conditioning in panic disorder., Biol. Psychiatry, 2013, 73, 1, 93-101, doi: 10.1016/j.biopsych.2012.07.026.

Additional files

Editorial Notes