Investigating the efficacy of self-guided digital treatment with virtual reality for panic disorder and agoraphobia
| ISRCTN | ISRCTN10661970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10661970 |
- Submission date
- 11/01/2022
- Registration date
- 17/01/2022
- Last edited
- 23/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People with panic disorder interpret thoughts and bodily sensations as dangerous or even life-threatening, leading to sudden and intense fear reactions. These panic attacks are often experienced as overwhelming. In agoraphobia, patients have panic-like attacks in places in which the access to help is limited or areas that are difficult to oversee. Avoidance behavior is a consequence that is common in both disorders, causing impairment and distress for troubled individuals.
Cognitive behavioral therapy (CBT) is the first-line treatment for patients with panic disorder and agoraphobia. Yet, many patients remain untreated due to limited treatment resources. Digital self-guided short-term treatment applications may help to overcome this issue. While some therapeutic applications are already supported by health insurance companies, data on their efficacy is limited. The current study aims at providing insights on the efficacy of short-term treatment applications including psychoeducation and self-guided virtual reality exposure therapy.
Who can participate?
People, who meet the diagnostic criteria for agoraphobia, unspecified (ICD-10 F40.00), agoraphobia with panic disorder (ICD-10 F40.01), agoraphobia without panic disorder (ICD-10 F40.02), and panic disorder (ICD-10 F41.00) can participate.
What does the study involve?
Patients diagnosed with panic disorder and agoraphobia will be randomly assigned to either the experimental (EG) or the control group (CG). Participants of both groups will undergo baseline diagnostics in the first two sessions. The subsequent treatment for the EG consists of a self-guided six-week phase of application-based psychoeducation, one therapy session preparing for the virtual reality exposure therapy (VRET), and four weeks of application based self-guided VRET. To control for potential effects of the therapy session with the therapist, the CG will receive relaxation training instead. All patients will then undergo a closing session which terminates with the post-assessment and a follow up assessment six weeks following the closing session.
What are the possible benefits and risks of participating?
A possible benefit is that the patient profits from the proposed intervention. No significant risks are linked to the participation in this study.
Where is the study run from?
University of Siegen (Germany)
When is the study starting and how long is it expected to run for?
April 2021 to March 2024
Who is funding the study?
DFG-Research Training Group 2493: Consequences of Social Work
University of Siegen (Germany)
Who is the main contact?
Jari Planert, M.Sc., jari.planert@uni-siegen.de
Contact information
Scientific
DFG-Research Training Group 2493
Hölderlinstr. 3
Siegen
57076
Germany
 ORCID ID |
0000-0002-8088-2511 |
|---|---|
| Phone | +49(0) 271-740-3887 |
| jari.planert@uni-siegen.de |
Study information
| Study design | Single center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial |
| Study objectives | 1. We expect that patients in the experimental condition experience a significant decline in severy of panic and agoraphobic symptoms compared to the control condition. 2. The secondary hypothesis is that at follow-up, significantly fewer participants in the experimental condition will meet the diagnostic criteria for panic disorder, agoraphobia, and panic disorder with agoraphobia, compared to the control condition. |
| Ethics approval(s) | Approved 11/04/2021, Siegen University Council for Research Ethics (Adolf-Reichwein Str. 2a, 57076 Siegen, Germany; +49(0) 271 / 740-4311; ethikrat@uni-siegen.de), ref: ER_48_2021 |
| Health condition(s) or problem(s) studied | Self-guided treatment for patients with panic disorder and agoraphobia |
| Intervention | First, all patients will have two psychotherapeutic sessions during which their symptoms will be assessed. At the end of the second session, random allocation to the research conditions will take place. The scheme that determines a patients’ allocation will be generated before study initiation using R.4.1.4. At this point, patients in the experimental group (EG) will receive access to the psychoeducational part of the self-guided digital treatment, for which they have six weeks to complete. Then, during the next session, patients in the EG will be prepared for the virtual reality part of the self-guided digital treatment, while patients in the control group (CG) receive relaxation training instead. Then, the EG has four weeks to complete the virtual reality part of the self-guided digital treatment. After that time, both groups will have a closing session, which will be used for the consolidation of learned behavior and relapse prevention. A follow-up session will take place six weeks after the closing session. |
| Intervention type | Behavioural |
| Primary outcome measure | Panic disorder and agoraphobia symptoms are measured using the German version of the Panic and Agoraphobia Scale (PAS) at baseline, interim (6 weeks), post-treatment (10 weeks), and follow-up (16 weeks) |
| Secondary outcome measures | Remission measured using the Mini-DIPS at baseline and follow-up (16 weeks) |
| Overall study start date | 11/04/2021 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 (20 per group) |
| Key inclusion criteria | One of the following diagnostic criteria: - Agoraphobia, unspecified (ICD-10 F40.00) - Agoraphobia with panic disorder (ICD-10 F40.01) - Agoraphobia without panic disorder (ICD-10 F40.02) - Panic disorder (ICD-10 F41.0) Note: All listed diagnoses can be in comorbidity with or without depression |
| Key exclusion criteria | 1. Stroke or myocardial infarction in patient history 2. Angina pectoris 3. Cardiac dysrhythmia 4. Asthma, chronic obstructive pulmonary disease 5. Pregnancy (or assumed pregnancy) 6. Severely impaired vision 7. Epilepsy or other cramp attacks in patient history 8. Psychological disorder with organic origin (f.e. dementia) 9. Dizziness or vestibular impairment 10. Psychological disorder due to use of psychoactive substances 11. Schizophrenia, schizotypal or delusional disorder 12. Severe depression 13. Acute suicidality or missing agreement in presence of suicidality |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 24/01/2024 |
Locations
Countries of recruitment
- Germany
Study participating centre
Siegen
57076
Germany
Sponsor information
University/education
Adolf-Reichwein-Straße 2
Siegen
57076
Germany
| Phone | +49 2717400 |
|---|---|
| presse@uni-siegen.de | |
| Website | https://www.uni-siegen.de/start/index.html.en?lang=en |
"ROR" |
https://ror.org/02azyry73 |
Funders
Funder type
Charity
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | 24/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the study protocol in Trials Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset will be available upon request from the corresponding author (Jari Planert; jari.planert@uni-siegen.de). The data will be available after the overall trial end. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/05/2022 | 23/05/2022 | Yes | No |
Editorial Notes
23/05/2022: Publication reference added.
25/01/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2022 to 24/01/2024.
2. The overall end date was changed from 24/01/2024 to 01/03/2024.
3. The plain English summary was updated to reflect these changes.
14/01/2022: Trial's existence confirmed by Universitat Siegen.
