The Efficacy of a Psychosomatic Intervention

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Parallel-Group Controlled Trial Examining the Efficacy of a Psychosomatic Intervention

Conditions
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Type D Personality, Trauma, Psychological

Intervention / Treatment
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* Procedure: Psychosensory Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (Treatment)<br>A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques). | Procedure: Psychosensory Therapy<br>* Havening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011).<br>* Other names: Psychosomatic Intervention;|
| No Intervention: Control Group (Waiting List)<br>Self-referral waiting list cohort (usual care). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the DS14 measure of Type D personality score at time point 3. | Repeat assessment of co-primary outcome measure 1. | 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. | 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). | 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1) | 
| 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). | 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). | 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). | 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). | 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). | 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. | 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. | 1 month post intervention (Time point 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosensory Therapy, Trauma, Psychological, DS14, CD-RISC, Resilience, Psychosomatic Medicine, Type D Personality, Salivary Cortisol, Blood Pressure, Havening Techniques