Condition category
Mental and Behavioural Disorders
Date applied
01/04/2019
Date assigned
08/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

N/A

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

www.uab.cat

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

Publication citations

Additional files

Editorial Notes

12/04/2019: Internal review. 08/04/2019: Trial's existence confirmed by the Ethical Committee for Clinical Research MAR Health Park.