Back to resultsThe Efficacy of a Psychosomatic Intervention
Primary Purpose
Type D Personality, Trauma, Psychological
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psychosensory Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type D Personality focused on measuring Psychosensory Therapy, Trauma, Psychological, DS14, CD-RISC, Resilience, Psychosomatic Medicine, Type D Personality, Salivary Cortisol, Blood Pressure, Havening Techniques
Eligibility Criteria
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.
Sites / Locations
- Psychology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group (Treatment)
Control Group (Waiting List)
Arm Description
A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques).
Self-referral waiting list cohort (usual care).
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Change in the DS14 measure of Type D personality score at 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.
Repeat assessment of co-primary outcome measure 2.
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).
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).
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).
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).
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).
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).
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.
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.
Full Information
NCT ID
NCT03568591
First Posted
May 21, 2018
Last Updated
June 14, 2018
Sponsor
Cardiff Metropolitan University
Collaborators
University of East Anglia
1. Study Identification
Unique Protocol Identification Number
NCT03568591
Brief Title
The Efficacy of a Psychosomatic Intervention
Official Title
A Parallel-Group Controlled Trial Examining the Efficacy of a Psychosomatic Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2016 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
November 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff Metropolitan University
Collaborators
University of East Anglia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type D Personality, Trauma, Psychological
Keywords
Psychosensory Therapy, Trauma, Psychological, DS14, CD-RISC, Resilience, Psychosomatic Medicine, Type D Personality, Salivary Cortisol, Blood Pressure, Havening Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
Coded-analysis group allocation and database - blind to allocation.
Allocation
Non-Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (Treatment)
Arm Type
Experimental
Arm Description
A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques).
Arm Title
Control Group (Waiting List)
Arm Type
No Intervention
Arm Description
Self-referral waiting list cohort (usual care).
Intervention Type
Procedure
Intervention Name(s)
Psychosensory Therapy
Other Intervention Name(s)
Havening Techniques, Psychosomatic Intervention
Intervention Description
Havening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011).
Primary Outcome Measure Information:
Title
Change from the baseline DS14 measure of Type D personality scores at time point 2.
Description
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)
Title
Change from the baseline Connor-Davidson Resilience Scale (CD-RISC) scores at time point 2.
Description
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)
Secondary Outcome Measure Information:
Title
Change in the DS14 measure of Type D personality score at time point 3.
Description
Repeat assessment of co-primary outcome measure 1.
Time Frame
1 month post intervention (Time point 3)
Title
Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.
Description
Repeat assessment of co-primary outcome measure 2.
Time Frame
1 month post intervention (Time point 3)
Title
Change in Systolic Blood Pressure from baseline to time point 2.
Description
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)
Title
Change in Systolic Blood Pressure at time point 3.
Description
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)
Title
Change in Diastolic Blood Pressure from baseline to time point 2.
Description
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)
Title
Change in Diastolic Blood Pressure at time point 3.
Description
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)
Title
Change in Heart Rate from baseline to time point 2.
Description
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)
Title
Change in Heart Rate at time point 3.
Description
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)
Title
Change in Salivary Cortisol levels from baseline to time point 2.
Description
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)
Title
Change in Salivary Cortisol Levels at time point 3.
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsty Hodgson
Organizational Affiliation
Psychology Department, Cardiff Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychology Department
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF5 2YB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15673629
Citation
Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.
Results Reference
background
PubMed Identifier
12964174
Citation
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
Results Reference
background
Links:
URL
https://www.routledge.com/When-the-Past-Is-Always-Present-Emotional-Traumatization-Causes-and/Ruden/p/book/9780415875646
Description
Ruden, R. (2011) When the Past is Always Present - Emotional Traumatisation, Causes, and Cures. USA: Routledge.
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The Efficacy of a Psychosomatic Intervention
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