The Efficacy of a Psychosomatic Intervention

June 14, 2018 updated by: Kirsty Hodgson, Cardiff Metropolitan University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF5 2YB
        • Psychology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
Time Frame: 1 month post intervention (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.
Time Frame: 1 month post intervention (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.
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).
24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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).
1 month post intervention (Time point 3)
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).
24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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).
1 month post intervention (Time point 3)
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).
24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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).
1 month post intervention (Time point 3)
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.
24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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.
1 month post intervention (Time point 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff Metropolitan University

Collaborators

University of East Anglia

Investigators

  • Principal Investigator: Kirsty Hodgson, Psychology Department, Cardiff Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2016

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMT1131992C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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