The Efficacy of a Psychosomatic Intervention

NCT ID: NCT03568591

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-11

Study Completion Date

2016-11-01

Brief Summary

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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

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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).

Conditions

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Type D Personality Trauma, Psychological

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Coded-analysis group allocation and database - blind to allocation.

Study Groups

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Intervention Group (Treatment)

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

Group Type EXPERIMENTAL

Psychosensory Therapy

Intervention Type 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).

Control Group (Waiting List)

Self-referral waiting list cohort (usual care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type PROCEDURE

Other Intervention Names

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Havening Techniques Psychosomatic Intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role collaborator

Cardiff Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Kirsty Hodgson

Principal Investigator - Research Lead

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirsty Hodgson

Role: PRINCIPAL_INVESTIGATOR

Psychology Department, Cardiff Metropolitan University

Locations

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Psychology Department

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 15673629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12964174 (View on PubMed)

Related Links

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https://www.routledge.com/When-the-Past-Is-Always-Present-Emotional-Traumatization-Causes-and/Ruden/p/book/9780415875646

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

Other Identifiers

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LMT1131992C

Identifier Type: -

Identifier Source: org_study_id

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