Determining the effectiveness of a structured group dynamic relaxation-training programme on reducing anxiety and depression symptoms
| ISRCTN | ISRCTN81798627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81798627 |
- Submission date
- 01/04/2019
- Registration date
- 08/04/2019
- Last edited
- 20/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Studies have persistently shown that anxiety disorders cause morbidity, increased use of health care services, decreased work productivity, work absence and will possibly be one of the leading causes of disability in the twenty-first century. In the treatment of anxiety disorders, psychopharmacological interventions with benzodiazepines and selective serotonin reuptake inhibitors (SSRI) have shown their efficacy. Non-pharmacologic interventions may be proposed as an alternative option, with the aim to reduce perceived anxiety and stress and to increase the sense of well being in the general population and relaxation – meditation techniques represent one of the most important alternatives in anxiety intervention worldwide.
The aim of the present study is to determine the effectiveness of an intensive four-week structured group relaxation-training program (sophrology’s dynamic relaxation) on anxiety and depression symptoms in primary care patients with moderate and high anxiety levels.
Who can participate?
Patients with moderate and high anxiety levels aged between 18 and 70 years.
What does the study involve?
Participants attend 12 one-hour sessions over a 4 week period. The intervention group will participate in the dynamic relaxation program called “well-being and sophrology” and the control group will participate in a cognitive program based on physical and mental health recommendations.
What are the possible benefits and risks of participating?
Possible benefits are the improvement of anxiety and depression symptoms. No risks expected as a result of participation.
Where is the study run from?
Medical Health Care Centre “Serraparera”, Cerdanyola, Barcelona.
When is the study starting and how long is it expected to run for?
May 2015.
Who is funding the study?
Investigator-initiated and funded.
Who is the main contact?
Koen van Rangelrooij
koen@sofrologia.com
Contact information
Scientific
Sofrocay
Balmes 177 pral 2
Barcelona
08006
Spain
| Phone | +34934511636 |
|---|---|
| koen@sofrologia.com |
Study information
| Study design | Interventional and experimental study design, single centre, randomized controlled trial, |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of a structured group relaxation-training programme based on sophrology’s dynamic relaxation techniques for primary care patients with moderate and high anxiety levels: a randomised controlled trial |
| Study objectives | The Dynamic relaxation programme (sophrology) is more effective than a physical and mental health recommendations programme in patients with moderate and high anxiety levels. |
| Ethics approval(s) | Approved 20/10/2015, the University Review Board of the Autonomous University of Barcelona (CEIm – Parc de Salut MAR, Dr. Aiguader, 88, 08003, Barcelona; 93 316 06 77; ceic-psmar@imim.es), ref: 2015/6141/I. |
| Health condition(s) or problem(s) studied | Anxiety |
| Intervention | Both programs covered a total of 12 one-hour sessions over 4 weeks (3 sessions a week). The intervention group followed the structured dynamic relaxation program called “well-being and sophrology” and the control group a cognitive program based on physical and mental health recommendations (PMHR). Simple random sampling was used. Two physicians, two nurses and a psychologist from the Medical Health Care Centre guided both the sophrology intervention and the PMHR (Physical and Mental Health Recommendations) control programme. |
| Intervention type | Behavioural |
| Primary outcome measure | Anxiety was measured using the Hospital Anxiety Depression Scale (HADS) and the State-Trait Anxiety Inventory (STAI) at the beginning of the first and the last session of the training programme. |
| Secondary outcome measures | N/A |
| Overall study start date | 16/03/2015 |
| Completion date | 19/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 patients |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. A score >7 for the Hospital Anxiety Depression Scale - anxiety subscale 2. 18 to 70 years of age |
| Key exclusion criteria | 1. Initiated or changed pharmacological, behavioural or any other therapy during the programme 2. Presented uncontrolled mental illness 3. Planned to participate in other therapies or similar programmes such as Yoga, Mindfulness, meditation, acupuncture, or other 4. During the programme suffered from important stressful life events 5. Not able to participate for linguistic, cultural or physical problems 6. Could not attend sessions regularly (<80% attendance) |
| Date of first enrolment | 04/05/2015 |
| Date of final enrolment | 22/05/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
Cerdanyola del Valles
08290
Spain
Sponsor information
University/education
Plaza Cívica.
08193 Bellaterra (Cerdanyola del Vallès)
Bellaterra
08193
Spain
| Phone | +34 93 581 11 11 |
|---|---|
| informacio@uab.cat | |
| Website | www.uab.cat |
"ROR" |
https://ror.org/052g8jq94 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in the “Journal of Psychosomatic Research”, the Spanish journal “Psiquiatría y Salud Mental” or another high impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2020 | 20/09/2021 | Yes | No |
Editorial Notes
20/09/2021: Publication reference added.
12/04/2019: Internal review.
08/04/2019: Trial's existence confirmed by the Ethical Committee for Clinical Research MAR Health Park.
