Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Koen van Rangelrooij
ORCID ID
Contact details
Sofrocay
Balmes 177 pral 2
Barcelona
08006
Spain
+34934511636
koen@sofrologia.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
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
Acronym
Study hypothesis
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
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.
Study design
Interventional and experimental study design, single centre, randomized controlled trial,
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
16/03/2015
Overall trial end date
19/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A score >7 for the Hospital Anxiety Depression Scale - anxiety subscale
2. 18 to 70 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70 patients
Total final enrolment
70
Participant 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)
Recruitment start date
04/05/2015
Recruitment end date
22/05/2015
Locations
Countries of recruitment
Spain
Trial participating centre
Medical Health Care Centre “Serraparera”
Carrer Diagonal, s/n,
Cerdanyola del Valles
08290
Spain
Sponsor information
Organisation
Autonomous university Barcelona
Sponsor details
Plaza Cívica.
08193 Bellaterra (Cerdanyola del Vallès)
Bellaterra
08193
Spain
+34 93 581 11 11
informacio@uab.cat
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement: the data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
15/04/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list