Stepped care for panic disorder [Stepped care voor paniekstoornis]
| ISRCTN | ISRCTN36376369 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36376369 |
| Secondary identifying numbers | 100003034 |
- Submission date
- 04/09/2012
- Registration date
- 09/10/2012
- Last edited
- 18/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims:
Panic disorder is a severe mental disease where patients experience (unexpected) frightful panic attacks. Most patients try to avoid these attacks by developing avoidance behaviour, e.g. they avoid crowded places. Panic disorder is also a burden for society as medical and social costs are high. Panic disorder treatment guidelines suggest cognitive behaviour therapy (CBT) or treatment with drugs, although CBT has known, longer lasting effects. Normally, CBT takes 10-12 weekly sessions, but CBT is not always easy available and waiting lists are long. Therefore, shorter and cheaper programs, such as guided self-help or internet based treatments have been tested and been successful in the treatment of panic disorder.
This study's goal is to examine whether a short program of guided self-help for panic disorder is beneficial, and only followed by more intensive treatment when necessary
Who can participate?
Patients with a panic disorder with or without agoraphobia. Either men or women, aged between 18-70 years.
What does the study involve?
130 patients (across different treatment centres) will be randomly allocated to one of two treatment conditions:
1. A brief CBT intervention (guided self-help) of 10 weeks followed by CBT (13 sessions) only when necessary
2. Treatment as usual according to the (NICE) guidelines
What are the possible benefits and risks of participating?
There are no negative risks known, since both treatment conditions are well studied and proven to be effective in the treatment for panic disorder. Benefits from enrolling in the study are the monitoring of symptoms and the adjustment of the therapy when necessary. A possible disadvantage is the extra time it may cost to fill in the extra questionnaires.
Where is the study run from?
Overwaal Nijmegen/Lent (part of ProPersona), The Netherlands (Lead Centre)
Hendriks & Roosenboom, private practice Arnhem, The Netherlands
Presenz (part of GgzIngeest), Amsterdam, The Netherlands
HSK Nijmegen en Den Bosch, The Netherlands
When is the study starting and how long is it expected to run for?
The study started in March 2009 and recruitment ended in March 2012. The last follow ups are expected at the end of 2012.
Who is funding the study?
ZONMW, The Netherlands.
Who is the main contact?
Dr Mirjam Kampman
m.kampman@propersona.nl
Contact information
Scientific
Pro Persona
Pastoor van Laakstraat 48
Lent
6663 CB
Netherlands
| Phone | +31 (0) 24 8200801 |
|---|---|
| m.kampman@propersona.nl |
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet [Dutch] |
| Scientific title | Panic disorder intervention for panic disorder with or without agoraphobia [Stepped care interventie voor patienten met paniekstoornis met en zonder agorafobie] |
| Study objectives | 1. Guided self help is an effective first step in the treatment of panic disorder, compared with treatment as usual. 2. In the second step of the stepped care intervention, manualised CBT, panic disorder symptoms will be faster in remission as compared to the treatment as usual. 3. Symptom severity, duration of panic disorder, comorbidity on axis I and II will not predict treatment results of guided self help. |
| Ethics approval(s) | Dutch Medical and Ethical Commission, Nijmegen, The Netherlands, 30 September 2008 ref: NL20312 09108 |
| Health condition(s) or problem(s) studied | Mental health, anxiety disorders, panic disorder, treatment studies |
| Intervention | This study consists of 2 conditions: 1. A first step of guided selfhelp, only when necessary followed by manualised CBT for panic disorder 2. Treatment as usual according to the NICE guidelines Cognitive behaviour therapy, guided self help, psychopharmacology (in treatment as usual). |
| Intervention type | Other |
| Primary outcome measure | 1. Panic and Agoraphobia Scale (PAS, Bandelow, 1999) 2. Outcome Questionnaire (OQ-45, Lambert and Burlingname, 2001) |
| Secondary outcome measures | 1. Agoraphobic Cognition Questionnaire (ACQ, Chambless et al., 1984) 2. Mobility Inventory (MI, Chambless, et al., 1984) 3. Body Sensations Questionnaire (BSQ, Chambless, et al., 1984) |
| Overall study start date | 15/03/2009 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 128 |
| Key inclusion criteria | 1. Participants have a present, primary diagnosis of panic disorder according to the DSM IV 2. Age between 18-70 3. Patiens give their informed consent 4. Patients are able to read and write the Dutch language |
| Key exclusion criteria | 1. A present diagnosis of schizophrenia or another psychotic disorder, according to the DSM-IV 2. Mental retardation, or another organic mental disorder 3. Suicidal ideation 4. Addiction to or abuse of drugs and/or alcohol 5. Another ongoing treatment for panic disorder (allthough the use of an SSRI or benzodiazepines is allowed in the treatment as usual condition) |
| Date of first enrolment | 15/03/2009 |
| Date of final enrolment | 01/03/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6663 CB
Netherlands
Sponsor information
Research organisation
Postbus 93 245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0) 70 3495111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
No information available
Results and Publications
| Intention to publish date | 23/07/2020 |
|---|---|
| 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/08/2020 | 18/11/2021 | Yes | No |
Editorial Notes
18/11/2021: Publication reference and total final enrolment added.
23/01/2019: Intention to publish date added.
