Trauma, Psychological, Type D Personality
Conditions
Keywords
Psychosensory Therapy, Trauma, Psychological, DS14, CD-RISC, Resilience, Psychosomatic Medicine, Type D Personality, Salivary Cortisol, Blood Pressure, Havening Techniques
Brief summary
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).
Detailed description
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).
Interventions
PROCEDUREPsychosensory Therapy
Havening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011).
Sponsors
University of East Anglia
Cardiff Metropolitan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Coded-analysis group allocation and database - blind to allocation.
Intervention model description
A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent. * Cognisant adults living in the United Kingdom. * Will have self-referred for Havening Techniques trauma therapy.
Exclusion criteria
* Receiving any other therapeutic or pharmaceutical intervention in parallel. * For the psychobiological evaluation subgroup: a history of HIV, Tuberculosis or Hepatitis B due to laboratory regulations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from the baseline DS14 measure of Type D personality scores at time point 2. | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | 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). |
| Change from the baseline Connor-Davidson Resilience Scale (CD-RISC) scores at time point 2. | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure from baseline to time point 2. | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | Systolic blood pressure will be assessed following rest in a sitting position (using an Omron hem 722c device). |
| Change in Systolic Blood Pressure at time point 3. | 1 month post intervention (Time point 3) | Systolic blood pressure will be assessed following rest in a sitting position (using an Omron hem 722c device). |
| Change in Diastolic Blood Pressure from baseline to time point 2. | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | Diastolic blood pressure and heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device). |
| Change in Diastolic Blood Pressure at time point 3. | 1 month post intervention (Time point 3) | Diastolic blood pressure and heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device). |
| Change in the DS14 measure of Type D personality score at time point 3. | 1 month post intervention (Time point 3) | Repeat assessment of co-primary outcome measure 1. |
| Change in Heart Rate at time point 3. | 1 month post intervention (Time point 3) | Heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device). |
| Change in Salivary Cortisol levels from baseline to time point 2. | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | 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. |
| Change in Salivary Cortisol Levels at time point 3. | 1 month post intervention (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. |
| Change in Heart Rate from baseline to time point 2. | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | Heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device). |
| Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3. | 1 month post intervention (Time point 3) | Repeat assessment of co-primary outcome measure 2. |
Countries
United Kingdom
Outcome results
None listed