The Efficacy of a Psychosomatic Intervention
- Conditions
- Type D PersonalityTrauma, Psychological
- Interventions
- Procedure: Psychosensory Therapy
- Registration Number
- NCT03568591
- Lead Sponsor
- Cardiff Metropolitan University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Able to provide informed consent.
- Cognisant adults living in the United Kingdom.
- Will have self-referred for Havening Techniques trauma therapy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (Treatment) Psychosensory Therapy A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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 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 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.
Trial Locations
- Locations (1)
Psychology Department
🇬🇧Cardiff, Wales, United Kingdom