Condition category
Mental and Behavioural Disorders
Date applied
15/12/2006
Date assigned
21/02/2007
Last edited
20/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.panik-netz.de

Contact information

Type

Scientific

Primary contact

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

ORCID ID

Contact details

Technische Universität Dresden
Institute for Clinical Psychology and Psychotherapy
Chemnitzer Str. 46
Dresden
01187
Germany
+49 (0)351 463 369 72
lang@psychologie.tu-dresden.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

040203-17

Study information

Scientific title

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Panic disorder with and without agoraphobia

Intervention

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

Other

Phase

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

01/05/2007

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

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

01/05/2007

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Technische Universität Dresden
Dresden
01187
Germany

Sponsor information

Organisation

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

Sponsor details

Heinrich-Konen-Str. 1
Bonn
53227
Germany
+49 (0)228 3821 118
detlef.boecking@dlr.de

Sponsor type

Government

Website

http://www.bmbf.de/en/index.php

Funders

Funder type

Government

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

Location

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 http://www.ncbi.nlm.nih.gov/pubmed/19876674
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21534651
3. 2012 additional results regarding the impact of depression on CBT in http://www.ncbi.nlm.nih.gov/pubmed/22399019
4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22921454

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