ISRCTN ISRCTN10682070
DOI https://doi.org/10.1186/ISRCTN10682070
Sponsor University of Lausanne
Funder Dr Randolph Willis
Submission date
19/08/2026
Registration date
20/08/2026
Last edited
20/08/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Randolph Willis
Principal investigator

Rue de la Paix 11
Montreux
1820
Switzerland

Phone +41 (0)796689273
Email dr.willis@hin.ch
Prof Yasser Khazaal
Scientific

Polyclinique d'addictologie - Département de Psychaitrie
Rue du Bugnon 23A
1011 Lausanne
Lausanne
1011
Switzerland

Phone +41 (0)213148400
Email yasser.khazaal@unil.ch
Prof Jean-Bernard Daeppen
Public

Polyclinique d'addictologie - Département de Psychaitrie
Rue du Bugnon 23A
1011 Lausanne
Lausanne
1011
Switzerland

Phone +41 (0)213148698
Email jean-bernard.daeppen@unil.ch

Study information

Primary study designObservational
Observational study designCohort study
Scientific titleA preliminary study of sophrology: a complementary approach to health
Study objectives This study evaluates the anti-anxiety effects of sophrology on moderate anxiety in patients.
Ethics approval(s)

Approved 01/12/1994, Cantonal Hospital Service Ethical Commission Psychiatry (Commission d'éthique clinique, Route de Cery 60, Prilly, 1008, Switzerland; +41 (0)213142967; ethique@chuv.ch), ref: 01121994

Health condition(s) or problem(s) studiedAnxiety disorders
MethodologyThis pilot study was a single-group, 6-week, pretest-posttest design with multiple outcomes.

Following enrollment but prior to initiation of sophrology therapy, participants completed the Hamilton Anxiety Scale (HAM-A; 0-56 scale; higher scores indicate more anxiety) in the office of the principal investigator (RW). Over the next 7 days (week 1), participants self-administered a salivary cortisol test (0-25 mcg/dl normal range) in the morning, afternoon, and evening of each day (samples were frozen and analyzed by an independent laboratory at Cochin Hospital, Paris); at each cortisol test, participants also completed the Norris Visual Analogical Scale (NVAS) for anxiety (0-100 scale; higher scores indicate more anxiety). During weeks 2-6 participants attended weekly sophrology sessions.

During week 6, participants repeated the week 1 protocol. At the end of week 6, the HAM-A was re-administered in the office setting.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Anxiety measured using the Hamilton Anxiety Scale at before and after 4 weeks of sophrology treatment
  2. Anxiety measured using the Visual Analogue Scale for Anxiety (VAS-A) at three times per day for 7 days before and after 4 weeks of sophrology treatment
  3. Anxiety measured using salivary levels of cortisol at three times per day for 7 days before and after 4 weeks of sophrology treatment
Key secondary outcome measure(s)
Completion date11/04/2016

Eligibility

Participant type(s)
Age groupAdult
Lower age limit20 Years
Upper age limit49 Years
SexAll
Target sample size at registration20
Total final enrolment20
Key inclusion criteriaPatients with anxiety symptoms that were primarily social/situational and did not require psychotropic medication
Key exclusion criteriaPatients taking medications, abusing substances, or using medications that interfere with cortisol levels
Date of first enrolment06/01/2000
Date of final enrolment20/12/2007

Locations

Countries of recruitment

  • Switzerland

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

20/08/2026: Study's existence confirmed by the Cantonal Hospital Service Ethical Commission Psychiatry.