Pilot Study: Response to Stress and Relaxation in Healthy Adults

Not Applicable

Conditions: Stress
Anxiety
Mental Health - Anxiety
Metabolic and Endocrine - Normal metabolism and endocrine development and function
Mental Health - Other mental health disorders

Registration Number: ACTRN12624000587505

Lead Sponsor: The New Zealand Institute for Plant & Food Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 16

Inclusion Criteria

Healthy males and females

Exclusion Criteria

Exclusion criteria include any serious ongoing medical conditions, low or high blood pressure (systolic less than 90 or higher than 120 or diastolic less than 60 or higher than 80), body mass index outside 19-26 kg/m2, and medication which can affect stress response including but not limited to antidepressant medication, blood pressure medication and asthma medication. Sex hormones can affect response to acute stress so women who are pregnant, lactating or using hormonal contraceptives will be excluded, and sessions will be run only during women’s luteal phase. People who work night shifts or have previously completed the Trier Social Stress Test procedure will also be excluded, as well as those with a current or prior diagnosis of Major Axis I DSM-IV disorders (American Psychiatric Association, 1994) including drug abuse or dependence, or high levels of anxiety or depression (The Hospital Anxiety and Depression Scale score above 15).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cortisol[Concentration in saliva Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions];Self-reported stress[Visual analogue scale Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions];Self-reported anxiety[The State Anxiety Inventory Questionnaire Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions]

Secondary Outcome Measures

Name	Time	Method
Cytokines (interferon-gamma (IFN-gamma), cytokine-induced neutrophil chemoattractant type-1 (CINC-1), monocyte chemoattractant protein-1 (MCP-1), tumour necrosis factor-alpha (TNF-a), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-18, IL-12p70, IL-1ß, IL-17A, IL-33, IL-1a, and IL-6) will be measured in combined samples. This is an exploratory outcome. [Concentration in saliva Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions];Heart Rate Variability[Armband heart rate monitor Baseline, following intervention, and at 20 and 40 minute post-intervention for each of the trier stress test and progressive muscle relaxation interventions]