Clinical trial NCT03568591: The Efficacy of a Psychosomatic Intervention
Official title: A Parallel-Group Controlled Trial Examining the Efficacy of a Psychosomatic Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Cardiff Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of East Anglia
First posted: 2018-06-26
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from the baseline DS14 measure of Type D personality scores at time point 2.
timeFrame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
measure: Change from the baseline Connor-Davidson Resilience Scale (CD-RISC) scores at time point 2.
timeFrame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
Secondary outcomes:
measure: Change in the DS14 measure of Type D personality score at time point 3.
timeFrame: 1 month post intervention (Time point 3)
measure: Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.
timeFrame: 1 month post intervention (Time point 3)
measure: Change in Systolic Blood Pressure from baseline to time point 2.
timeFrame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
measure: Change in Systolic Blood Pressure at time point 3.
timeFrame: 1 month post intervention (Time point 3)
measure: Change in Diastolic Blood Pressure from baseline to time point 2.
timeFrame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
measure: Change in Diastolic Blood Pressure at time point 3.
timeFrame: 1 month post intervention (Time point 3)
measure: Change in Heart Rate from baseline to time point 2.
timeFrame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
measure: Change in Heart Rate at time point 3.
timeFrame: 1 month post intervention (Time point 3)
measure: Change in Salivary Cortisol levels from baseline to time point 2.
timeFrame: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
measure: Change in Salivary Cortisol Levels at time point 3.
timeFrame: 1 month post intervention (Time point 3)
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Psychology Department
state: Wales
Study officials:
affiliation: Psychology Department, Cardiff Metropolitan University
name: Kirsty Hodgson
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.