The Efficacy of a Psychosomatic Intervention

NCT03568591 | Completed DMC

• 1 other identifier: LMT1131992C
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• Change in the DS14 measure of Type D personality score at time point 3.

  1 month post intervention (Time point 3)

• Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.

  1 month post intervention (Time point 3)

• Change in Systolic Blood Pressure from baseline to time point 2.

  24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)

• Change in Systolic Blood Pressure at time point 3.

  1 month post intervention (Time point 3)

• Change in Diastolic Blood Pressure from baseline to time point 2.

  24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)

Study Arms (2)

Intervention Group (Treatment)

EXPERIMENTAL

A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques).

Procedure: Psychosensory Therapy

Control Group (Waiting List)

NO INTERVENTION

Self-referral waiting list cohort (usual care).

Interventions

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).

Also known as: Havening Techniques, Psychosomatic Intervention

Intervention Group (Treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent.
• Cognisant adults living in the United Kingdom.
• Will have self-referred for Havening Techniques trauma therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiff Metropolitan University: lead
• University of East Anglia: collaborator

Study Sites (1)

Psychology Department

Cardiff, Wales, CF5 2YB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 15673629 BACKGROUND

• 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.

  PMID: 12964174 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kirsty Hodgson

  Psychology Department, Cardiff Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Coded-analysis group allocation and database - blind to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Research Lead

Model Details: A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 26, 2018
• Study Start: June 11, 2016
• Primary Completion: October 31, 2016
• Study Completion: November 1, 2016
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)