Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000245

Trial Description

start of 1:1-Block title

Title

Short-term psychotherapy for patients with panic disorder with or without agoraphobia - a randomised comparative study between the panic-focused psychodynamic and cognitive behavioural psychotherapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PfPP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Panic disorder is characterized by sudden and intensive anxiety and is often linked with agoraphobia, it is one of the most common mental disorders. Furthermore additional mental and physical disorders accompany panic disorder, e. g. depression, substance abuse and somatoform disorders.
Today cognitive behavioural psychotherapy (CBT) is, as far as the evaluation is concerned, the best investigated treatment. Although its high efficacy has been demonstrated, a substancial proportion of patients (38%) is still suffering from panic symptoms after treatment. Therefore, alternative psychotherapeutic treatments are needed to met the needs of these patients. Milrod et al (1997, German version Beutel et al, 2005) developed the panic-focussed psychodynamic psychotherapy for panic disorder (PFPP), a short term treatment with two session per week over three months. The efficacy of the PFPP was demonstrated in an US sample (Milrod et al, 2007). Our study investigates the generalizability and efficacy of the PFPP in a German sample.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Aim of this clinical study is to evaluate the efficacy of the manualised panic-focused psychodynamic psychotherapy for the treatment of patients with a primary panic disorder. Treatment is administered from expert clinicians working in a clinic for psychosomatic medicine or psychotherapists in private practice. The reference group is treated according to the manualised cognitive behavioural therapy for panic disorder matched for the number of sessions and duration; CBT was also administered by expert clinicians. This was done to ensure the comparability of both intervention groups. Four assessments were conducted: pre- and post treatment, as well as 6 and 24 months later, to test whether the effects are enduring.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000245
  •   2009/12/08
  •   [---]*
  •   yes
  •   Approved
  •   837.317.05 (4975), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1112-4245 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F40.01 -  [generalization F40.0: Agoraphobia]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   PfPP (panic-focused psychodynamic psychotherapy for patients with panic disorder)
    25 sessions in three months
  •   CBT (cognitive behavioral therapy)
    25 sessions in three months
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   assessor
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Principal outcome criterion is the reduction of panic-related symptoms at the follow-up 6-months after treatment. Panic-related symptoms are measured with standardized questionnaires and interviews, e. g. the AKV-MI/BSQ/ACQ questionnaires, the Hamilton Anxiety Scale, HAMA, and the Panic Disorder Severity scale, PDSS. To test the hypothized equivalence of both interventional arms adequate statistical procedures will be used.
All questionnaires and interviews were conducted at all occasions of mneasurement.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Severity of the panic-related symptoms at the follow up 24-months after treatment.
Security of Attachment (Adult Attachment Projective, Adult Attachment Scale), Levels of emotional Awareness (LEAS) and panic-specific reflective functioning (RF) are secondary targets of analyses. Furthermore additional questionnaires and interviews were conducted (e.g. STAI and SPAI for anxiety, BDI for depression, SCL-90 for general psychopathology, CDS for depersonalisation, IIP-D for interpersonal integration, GAF, BIKEP measuring satisfaction with therapy, and manual-adherence of all therapists). With the exception of the SCID and the BIKEPs all test and interviews were conducted at all occasions of measurement.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2006/01/27
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Agoraphobia with Panic Disorder (F40.01) or Panic Disorder(F 41.0)
Current symptoms (at least one panic attack within the last 4 weeks)
Informed consent
Sufficient command of the German language

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Schizophrenia or affective psychosis.
Current severe depression.
Borderline personality disorder.
Severe neurological or internal diseases.
Substance addiction.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie der Universitätsmedizin Mainz, K. ö. R.
    • Mr.  Prof. Dr. med.  Manfred  Beutel 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Ms.  Dr.  Claudia  Subic-Wrana 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Ms.  PD Dr.  Claudia  Subic-Wrana 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Mainzer Forschungsförderungsprogramm MAIFOR Ressort Forschung und Lehre Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Obere Zahlbacher Str. 63
    • 55131  Mainz
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2011/05/29
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Subic-Wrana C, Knebel A, Maucher V, Beutel ME (März 2008). Die Mainzer PFPP-Studie: Vergleich einer psychoanalytischen und einer verhaltenstherapeutischen Kurzzeitpsychotherapie der Panikstörung. Vortrag bei der DKPM/ DGPM-Tagung: Freiburg, Breisgau. Psychologische Medizin, Sonderheft DKPM/ DGPM-Tagung: p. 56.
  •   Subic-Wrana C, Knebel A, Wiltink J, Beutel ME (2010, July). The Mainz PFPP-Study:
    An RCT comparing a Psychodynamic
    and a Cognitive-Behavioral Short-Term
    Psychotherapy for Panic Disorder. Lecture presented at the 41st Annual Meeting SPR, Asilomar, California.
  •   Beutel, M.E.; Scheurich, V.; Knebel, A.; Michal, M.; Wiltink, J.; Graf-Morgenstern, M.; Tschan, R.; Milrod, B.; Wellek, S.; Subic-Wrana, C. Implementing Panic-focused Psychodynamic Psychotherapy into clinical practice. The Canadian Journal of Psychiatry/La Revue canadienne de psychiatrie (in review)
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.