Condition category
Mental and Behavioural Disorders
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
15/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Franske J. Apeldoorn van

ORCID ID

Contact details

University Medical Center Groningen
P.O. Box 30.001
Groningen
9700 RB
Netherlands
-
f.j.van.apeldoorn@psy.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized, prospective, multicenter study of the effective treatments of panic disorder: cognitive behavioral therapy versus antidepressants versus combination therapy

Acronym

PD-study

Study hypothesis

In the short-term, the combined treatment is expected to be superior to either mono-treatment. In the long-term, it is expected that cognitive behavioral therapy (CBT) will prove to be more durable and that patients taking selective serotonin reuptake inhibitor (SSRI) will require more mental health care during the one-year follow-up period.

Ethics approval

Not provided at time of registration

Study design

A randomized, prospective, multicenter study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Panic disorder

Intervention

CBT: the CBT protocol is based on the work of Clark and Barlow. Patients in the CBT group received up to 21 CBT sessions each lasting approximately 50 minutes. From session 16 onwards, sessions were scheduled with five-week intermissions. CBT consisted of the following:
1. Interoceptive exposure
2. Cognitive therapy
3. Exposure-in-vivo

SSRI group: patients receiving an SSRI visited their therapist 12 times, with weekly sessions during the first month and the remaining sessions distributed evenly over the treatment period of one year. Each visit lasted approximately 20 minutes. SSRIs used: fluvoxamine, sertraline, citalopram, fluoxetine, and cipramil. Tapering started three months before post-test.

Combination therapy of CBT and SSRI group: patients received both treatments, delivered in a parallel manner by different therapists.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluvoxamine, sertraline, citalopram, fluoxetine, cipramil

Primary outcome measures

Short-term:
1. Hamilton anxiety
2. Hamilton depression
3. Frequency of panic attacks
4. Responder status
5. Symptom checklist-90 (SCL-90)
6. Fear questionnaire-subscale
7. Agoraphobia

Long-term:
1. Remitter status
2. Panic coping
3. Quality of life
4. Hamilton anxiety
5. Hamilton depression

Secondary outcome measures

1. Treatment satisfaction
2. Locus of control
3. Fear of bodily sensations
4. Anticipation anxiety
5. Negative and positive self statements

Overall trial start date

01/01/2001

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients suffering from a primary diagnosis of panic disorder (PD) with or without agoraphobia (AG) (according to Diagnostic and Statistical Manual of mental disorders [DSM-IV] classification) recruited in 11 treatment facilities throughout the Netherlands between 1 April 2001 and 1 October 2003.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Comorbid psychotic disorder
2. Drug dependence
3. Major affective disorder
4. Significant risk of suicidality
5. Pregnancy or lactation
6. Contraindications to either treatment modality

Recruitment start date

01/01/2001

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23676529
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23834587

Publication citations

  1. Results

    Van Apeldoorn FJ, Van Hout WJ, Timmerman ME, Mersch PP, den Boer JA, Rate of improvement during and across three treatments for panic disorder with or without agoraphobia: cognitive behavioral therapy, selective serotonin reuptake inhibitor or both combined., J Affect Disord, 2013, 150, 2, 313-319, doi: 10.1016/j.jad.2013.04.012.

  2. Results

    van Apeldoorn FJ, Stant AD, van Hout WJ, Mersch PP, den Boer JA, Cost-effectiveness of CBT, SSRI, and CBT+SSRI in the treatment for panic disorder, Acta Psychiatr Scand, 2014, 129, 4, 286-295, doi: 10.1111/acps.12169.

Additional files

Editorial Notes