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Completed

NCT Number: NCT03568591

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).

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Key information

Conditions

Type D Personality Mental Disorders Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychology Department

Cardiff, Wales, CF5 2YB, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychosensory Therapy

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cardiff Metropolitan University

Other

Collaborators

  • University of East Anglia

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2018
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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