The Efficacy of a Psychosomatic Intervention

Trauma, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568591
• Other study ID #: LMT1131992C
• Status: Completed
• Phase: N/A
• Start date: June 11, 2016
• Est. completion date: November 1, 2016

Study information

• Verified date: June 2018
• Source: Cardiff Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 1, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Trauma
• Trauma, Psychological
• Type D Personality

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Psychology Department	Cardiff	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff Metropolitan University	University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. — View Citation

Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Ruden, R. (2011) When the Past is Always Present - Emotional Traumatisation, Causes, and Cures. USA: Routledge.