A randomized, prospective, multicenter study of the effective treatments of panic disorder: cognitive behavioral therapy versus antidepressants versus combination therapy
| ISRCTN | ISRCTN08156869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08156869 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/07/2006
- Registration date
- 19/07/2006
- Last edited
- 15/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Franske J. Apeldoorn van
Scientific
Scientific
University Medical Center Groningen
P.O. Box 30.001
Groningen
9700 RB
Netherlands
| f.j.van.apeldoorn@psy.umcg.nl |
Study information
| Study design | A randomized, prospective, multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomized, prospective, multicenter study of the effective treatments of panic disorder: cognitive behavioral therapy versus antidepressants versus combination therapy |
| Study acronym | PD-study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluvoxamine, sertraline, citalopram, fluoxetine, cipramil |
| Primary outcome measure | 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 study start date | 01/01/2001 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
University/education
University/education
P.O. Box 30001
Groningen
9700 RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/09/2013 | Yes | No | |
| Results article | results | 01/04/2014 | Yes | No |
