Relaxation for Anxiety in healthy adults

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: Relaxation training (yoga nidra), 8 week training, 2x30 min per week Of the two sessions, one session is face‐to‐face, and at least one session is received online via audio recording that can be accessed via an online link Participants will be instructed verbally by the teacher (psychologist) during the session, with no additional tools or props used The yoga nidra training uses different components, including imagery, breathing, body scan and awareness, as well as light movements Participants remain in a supine position for the relaxation intervention, using a mat, and blankets as needed to be comfortable The adherence will be monitored by attendance lists (face‐to‐face), and an online log (online sessions) The same intervention will be during the EEG (electroencephalography) sub‐study, only that it will be carried out in the EEG lab, and in a comfortable chair, where the brain activity will be measured during yoga nidra. A total of 20 participants across both groups (ideally 10 each) will participate in the EEG study. CONDITION: Mental Health ��� Anxiety subclinical anxiety; ; subclinical anxiety PRIMARY OUTCOME: Feasibility via attrition rate assessed using audit of study records[end of study] Feasibility via recruitment success assessed using audit of study recruitment records[end of enrolment] Feasibility via treatment adherence assessed using session attendance records and checklists, as well as online trackers for online components[end of interventions (8 weeks post‐baseline)] SECONDARY OUTCOME: Anxiety via Beck Anxiety Inventory (BAI)[baseline (pre‐intervention) and end of interventions (8 weeks post‐baseline)] Anxiety via PROMIS Short Form v1.0 ‐ Anxiety 8[baseline (pre‐intervention) and end of interventions (8 weeks post‐baseline)] Anxiety via State Trait Anxiety Inventory (STAI)[baseline (pre‐intervention) and end of interventions (8 weeks post‐baseline)] Meditation Depth via Meditation Depth Questionnaire (MEDEQ)[end of interventions (8 weeks post‐baseline)] Neural Activity via brain wave patterns assessed using electroencephalogram (EEG)[baseline (pre‐intervention) and end of interventions (8 weeks post‐baseline)] Safety via adverse events in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0), measured via self‐report at each contact with the investigators ; Common self‐reported adverse effects of relaxation can be emotional reactions, or drowsiness/fatigue after the training.[weekly (1‐8 weeks post baseline) ; end of interventions (8 weeks post‐baseline)] Satisfaction with interventions[end of interventions (8 weeks post‐baseline) via semi‐structured qualitative interviews one‐on‐one, and face to face with a member of the research team] Stress via Perceived Stress Scale (PSS)[baseline (pre‐intervention) and end of interventions (8 weeks post‐baseline)] Worry via Penn State Worry Questionnaire (PSWQ)[baseline (pre‐intervention) and end of interventions (8 weeks post‐baseline)] INCLUSION CRITERIA: ‐ Healthy ‐ Aged 18 or older ‐ Mild anxiety (5‐15 points on the Generalised Anxiety Disorder Scale (GAD‐7) ‐ Access to computer or smartphone for access to online session material ‐ Availability for the duration of the eight week in‐person intervention as well as availability one week before and after for pre‐screening, filling out before and after questionnaires, and completion of documents
Epistemonikos ID: 8947529408a53b570f5b1b61aafa7f214384b145
First added on: Aug 26, 2024