The effectiveness of cognitive behavioural therapy versus interpersonal psychotherapy in panic disorder with agoraphobia
| ISRCTN | ISRCTN95465806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95465806 |
| Secondary identifying numbers | NL639, NTR699 |
- Submission date
- 19/07/2006
- Registration date
- 19/07/2006
- Last edited
- 08/01/2021
- 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 Linsey Diels
Scientific
Scientific
University Maastricht (UM)
P.O.Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3881264 |
|---|---|
| L.Diels@dmkep.unimaas.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The effectiveness of cognitive behavioural therapy versus interpersonal psychotherapy in panic disorder with agoraphobia |
| Study objectives | In this study, we will test the effectiveness of Cognitive Behavioural Therapy (CBT) versus Interpersonal PsychoTherapy (IPT) in panic disorder with agoraphobia. |
| Ethics approval(s) | Ethics Board of the Community Mental Health Centre Maastricht, ethic approval granted on the 30th September 1996 (ref: GWA 96.070) |
| Health condition(s) or problem(s) studied | Panic disorder, agoraphobia |
| Intervention | Patients will receive 12 therapeutic sessions of either cognitive behavioural therapy (CBT) or interpersonal psychotherapy (IPT), one session per week, each session takes one hour. |
| Intervention type | Other |
| Primary outcome measure | 1. Panic free status (defined with panic diaries) 2. Performance on a behavioural test (three situations) Panic diaries are completed at zero months (pre-treatment), during treatment, three months (post treatment), four months (follow up one) and nine months (follow up two). Performance on the behavioural test is assessed at zero months (pre-treatment), four months (follow up one) and nine months (follow up two). |
| Secondary outcome measures | 1. A composite measure of panic and agoraphobic measures (the Fear Questionnaire [FQ v+a], main phobia, Anxiety Sensitivity Index [ASI], Fear Of Fear [FOF], etc.,) 2. A composite measure of cognitive measures (e.g. Body Sensations Interpretation Questionnaire [BSIQ-14], Agoraphobic Cognitions Questionnaire [ACQ]) 3. An interpersonal measure (the Inventory of Interpersonal Problems [IIP]) 4. A composite measure of general psychopathology (the Symptom CheckList-90-R [SCL-90], State-Trait Anxiety Inventory [STAI]) The outcomes are assessed at zero months (pre-treatment), three months (post treatment), four months (follow up one) and nine months (follow up two). |
| Overall study start date | 18/09/1996 |
| Completion date | 23/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 92 |
| Total final enrolment | 91 |
| Key inclusion criteria | 1. Main diagnosis panic disorder with moderate/severe agoraphobia 2. Aged between 18 and 60 |
| Key exclusion criteria | 1. Co-morbid psychosis or bipolar disorder 2. The use of psychoactive drugs 3. Intelligence Quotient (IQ) less than 80 4. Insufficient knowledge of the Dutch language 5. Previous formal IPT or CBT received (for the same complaint in the past year) 6. Alcohol or drugs dependency 7. Cardiovascular disease 8. Respiratory disease 9. Epilepsy |
| Date of first enrolment | 18/09/1996 |
| Date of final enrolment | 23/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht (UM)
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
Research Institute Experimental Psychopathology (EPP) (The Netherlands)
Research organisation
Research organisation
Department of Clinical, Medical, and Experimental Psychology
P.O.Box 616
Maastricht
6200 MD
Netherlands
"ROR" |
https://ror.org/02jz4aj89 |
|---|
Funders
Funder type
University/education
University Maastricht (UM), Research Institute Experimental Psychopathology (EPP), Department of Clinical, Medical, and Experimental Psychology (The Netherlands)
No information available
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 | 01/12/2012 | 08/01/2021 | Yes | No |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
