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The Efficacy of a Psychosomatic Intervention

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ClinicalTrials.gov Identifier: NCT03568591
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
University of East Anglia
Information provided by (Responsible Party):
Kirsty Hodgson, Cardiff Metropolitan University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Type D Personality Trauma, Psychological Procedure: Psychosensory Therapy Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Coded-analysis group allocation and database - blind to allocation.
Primary Purpose: Treatment
Official Title: A Parallel-Group Controlled Trial Examining the Efficacy of a Psychosomatic Intervention
Actual Study Start Date : June 11, 2016
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : November 1, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group (Treatment)
A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques).
 Procedure: Psychosensory 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).
Other Names:
  • Havening Techniques
  • Psychosomatic Intervention
No Intervention: Control Group (Waiting List)
Self-referral waiting list cohort (usual care).


Outcome Measures
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Primary Outcome Measures :
  1. Change from the baseline DS14 measure of Type D personality scores at time point 2. [ Time Frame: 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).

  2. Change from the baseline Connor-Davidson Resilience Scale (CD-RISC) scores at time point 2. [ Time Frame: 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 :
  1. Change in the DS14 measure of Type D personality score at time point 3. [ Time Frame: 1 month post intervention (Time point 3) ]
    Repeat assessment of co-primary outcome measure 1.

  2. Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3. [ Time Frame: 1 month post intervention (Time point 3) ]
    Repeat assessment of co-primary outcome measure 2.

  3. Change in Systolic Blood Pressure from baseline to time point 2. [ Time Frame: 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).

  4. Change in Systolic Blood Pressure at time point 3. [ Time Frame: 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).

  5. Change in Diastolic Blood Pressure from baseline to time point 2. [ Time Frame: 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).

  6. Change in Diastolic Blood Pressure at time point 3. [ Time Frame: 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).

  7. Change in Heart Rate from baseline to time point 2. [ Time Frame: 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).

  8. Change in Heart Rate at time point 3. [ Time Frame: 1 month post intervention (Time point 3) ]
    Heart rate will be assessed following rest in a sitting position (using an Omron hem 722c device).

  9. Change in Salivary Cortisol levels from baseline to time point 2. [ Time Frame: 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.

  10. Change in Salivary Cortisol Levels at time point 3. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568591


Locations
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United Kingdom
Psychology Department
Cardiff, Wales, United Kingdom, CF5 2YB
Sponsors and Collaborators
Cardiff Metropolitan University
University of East Anglia
Investigators
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Principal Investigator: Kirsty Hodgson Psychology Department, Cardiff Metropolitan University
More Information
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Additional Information:

Publications:

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Responsible Party: Kirsty Hodgson, Principal Investigator - Research Lead, Cardiff Metropolitan University
ClinicalTrials.gov Identifier: NCT03568591    
Other Study ID Numbers: LMT1131992C
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirsty Hodgson, Cardiff Metropolitan University:
Psychosensory Therapy
Trauma, Psychological
DS14
CD-RISC
Resilience
 Psychosomatic Medicine
Type D Personality
Salivary Cortisol
Blood Pressure
Havening Techniques
Additional relevant MeSH terms:
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Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders