This study examines the efficacy of a psychosensory intervention in relation to: Resilience, Type D personality, and physiological effects (on blood pressure, heart rate and salivary cortisol) in a group of people who have self-referred for the trauma resolution psychosensory therapy - Havening Techniques (HT).
This study utilizes a single blind (researcher blind) comparison of the psychosensory therapy Havening Techniques (treatment) versus waiting list (no treatment). Participants will be assessed using resilience testing (CD-RISC), and Type D measure of personality (DS14). A subgroup of the treatment arm will be assessed for the biomarkers of blood pressure, heart rate and cortisol. This parallel-group controlled trial will examine the efficacy of Havening Techniques at 3 timepoints; baseline (Time point 1), twenty-four hours post (Time point 2) and one month later (Time point 3).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
125
Havening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011).
Psychology Department
Cardiff, Wales, United Kingdom
Change from the baseline DS14 measure of Type D personality scores at time point 2.
Co-primary outcome measure: The DS14 measure of Type D personality is a 14-item questionnaire that uses a 5-point likert scale, each item weighted from 0 to 4. The DS14 incorporates the two 7-item subscales measuring the negative affect and social inhibition constituents of Type D personality (Denollet, 2005).
Time frame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Change from the baseline Connor-Davidson Resilience Scale (CD-RISC) scores at time point 2.
Co-primary outcome measure: The Connor-Davidson Resilience Scale (CD-RISC) assesses resilience and constitutes a 25=item questionnaire scored on a 5-point likert scale (rated 0-4). This scale has been successfully applied to evaluate change in intervention studies targeted at resilience (Connor and Davidson, 2003).
Time frame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Change in the DS14 measure of Type D personality score at time point 3.
Repeat assessment of co-primary outcome measure 1.
Time frame: 1 month post intervention (Time point 3)
Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.
Repeat assessment of co-primary outcome measure 2.
Time frame: 1 month post intervention (Time point 3)
Change in Systolic Blood Pressure from baseline to time point 2.
Systolic blood pressure will be assessed following rest in a sitting position (using an Omron hem 722c device).
Time frame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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Change in Systolic Blood Pressure at time point 3.
Systolic blood pressure will be assessed following rest in a sitting position (using an Omron hem 722c device).
Time frame: 1 month post intervention (Time point 3)
Change in Diastolic Blood Pressure from baseline to time point 2.
Diastolic blood pressure and heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device).
Time frame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Change in Diastolic Blood Pressure at time point 3.
Diastolic blood pressure and heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device).
Time frame: 1 month post intervention (Time point 3)
Change in Heart Rate from baseline to time point 2.
Heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device).
Time frame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Change in Heart Rate at time point 3.
Heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device).
Time frame: 1 month post intervention (Time point 3)
Change in Salivary Cortisol levels from baseline to time point 2.
Salivette recordings taken at identical times of day (to avoid circadian influences) following rest in a sitting position. Dietary consistency and avoidance of alcohol advised to avoid confounding variables. Samples to be analysed by the clinical laboratory.
Time frame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Change in Salivary Cortisol Levels at time point 3.
Salivette recordings taken at identical times of day (to avoid circadian influences) following rest in a sitting position. Dietary consistency and avoidance of alcohol advised to avoid confounding variables. Samples to be analysed by the clinical laboratory.
Time frame: 1 month post intervention (Time point 3)