Effectiveness of sophrology (a mind-body method) on patients with anxiety

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Patients are randomly assigned into two groups of 35 participants following simple randomization. Following the list of selected patients, every multiple of seven is called by telephone (patient 7,14, 21, etc) and alternately assigned to the intervention group or the control group until the number of 35 participants is reached for each group. The sample size is based on medical and statistical considerations. The sophrology group receive the structured Sophrologie & wellbeing (SW) intervention for 4 consecutive weeks at a rate of two weekly sessions of 1 hour each (theory and practical). The first half of the program is dedicated to a theoretical part (50%) and the other half to practising sophrology techniques (50%), which consist of training in relaxation techniques, breathing exercises, as well as imaging and mental programming techniques (for the past, present, future and personal values). At the end of each session the group receive a summary of the theoretical part and a digital recording of the practised sophrology technique. They are motivated to train daily and to apply what they learn in everyday life and are instructed to know how to manage stress properly and develop a more serene and positive attitude. The control group receive the exclusively theory‐based Healthy Habit Program (HHP) intervention for 4 weeks, also with two 1‐hour sessions per week. The program consists of a theoretical part similar to the SW program, and a more interactive part on promoting healthy habits in the face of stress. This interactive part consists of informative videos and/or specialized lectures on the topics covered in the theoretical part. At the beginning of the intervention, participants are informed of the possibility to continue with the sophrology program once the HHP CONDITION: Moderate and high anxiety levels ; Mental and Behavioural Disorders PRIMARY OUTCOME: 1. Anxiety and depression symptoms measured using the Hospital Anxiety Depression Scale (HADS) at baseline and after 4 consecutive weeks; 2. State and trait anxiety levels measured using the State‐Trait Anxiety Inventory (STAI) at baseline and after 4 consecutive weeks SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. Scored =8 points on the HAD‐Anxiety subscale 2. Older than 18 years and younger than 70 years 3. Expressed a formal wish to take part in the research 4. Not presenting any of the exclusion criteria 5. Read and signed an informed consent document
Epistemonikos ID: 0450f599cc0429b8b5dfab369075c23525c505ba
First added on: Aug 25, 2024