Type D PersonalityNCT03568591
The Efficacy of a Psychosomatic Intervention
A study testing Psychosensory Therapy in people with Type D Personality and Trauma, Psychological, run by Cardiff Metropolitan University at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type D Personality, Trauma, Psychological
- What is being tested?
- Psychosensory Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2016to 1 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- Cognisant adults living in the United Kingdom.
- Will have self-referred for Havening Techniques trauma therapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel-Group Controlled Trial Examining 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).
Read the 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).
- Conditions
- Type D Personality, Trauma, Psychological
- Being tested
- Psychosensory Therapy
- Keywords
- Psychosensory Therapy, Trauma, Psychological, DS14, CD-RISC, Resilience, Psychosomatic Medicine, Type D Personality, Salivary Cortisol, Blood Pressure, Havening Techniques
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosensory TherapyProcedure or surgery
Also called Havening Techniques, Psychosomatic Intervention
Havening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Treatment) | Experimental | A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques). Receives: Procedure: Psychosensory Therapy |
| Control Group (Waiting List) | No intervention | Self-referral waiting list cohort (usual care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Repeat assessment of co-primary outcome measure 1.
Measured: 1 month post intervention (Time point 3)
Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.
Repeat assessment of co-primary outcome measure 2.
Measured: 1 month post intervention (Time point 3)
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).
Measured: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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).
Measured: 1 month post intervention (Time point 3)
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).
Measured: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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).
Measured: 1 month post intervention (Time point 3)
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).
Measured: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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).
Measured: 1 month post intervention (Time point 3)
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.
Measured: 24 hours post intervention (Time point 2) versus pre-intervention (Time point 1)
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.
Measured: 1 month post intervention (Time point 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start11 Jun 2016
- Primary completion31 Oct 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type D PersonalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Principal investigator, Kirsty Hodgson, Cardiff Metropolitan University
- Investigators
- Kirsty Hodgson, Principal investigator, Psychology Department, Cardiff Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568591
- Sponsor's protocol ID
- LMT1131992C
- Status last verified
- Jun 2018
- First submitted
- 21 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15673629Connor 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.
PubMed 12964174
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-Group Controlled Trial Examining the Efficacy of a Psychosomatic Intervention
- ClinicalTrials.gov ID
- NCT03568591
- Acronym / sponsor ID
- LMT1131992C
- Conditions
- Type D Personality, Trauma, Psychological
- Keywords
- Psychosensory Therapy, Trauma, Psychological, DS14, CD-RISC, Resilience, Psychosomatic Medicine, Type D Personality, Salivary Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Cardiff Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 11 Jun 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Treatment) | Experimental | Procedure: Psychosensory TherapyA treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques). |
| Control Group (Waiting List) | No intervention | –Self-referral waiting list cohort (usual care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide informed consent.
- Cognisant adults living in the United Kingdom.
- Will have self-referred for Havening Techniques trauma therapy.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosensory TherapyAlso: Havening Techniques, Psychosomatic InterventionHavening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011). | Procedure or surgery | Intervention Group (Treatment) |
Primary outcome
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).
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).
10 secondary outcomes
Change in the DS14 measure of Type D personality score at time point 3.
Time frame: 1 month post intervention (Time point 3)
Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3.
Time frame: 1 month post intervention (Time point 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)
Change in Systolic Blood Pressure at time point 3.
Time frame: 1 month post intervention (Time point 3)
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)
Change in Diastolic Blood Pressure at time point 3.
Time frame: 1 month post intervention (Time point 3)
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)
Change in Heart Rate at time point 3.
Time frame: 1 month post intervention (Time point 3)
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)
Change in Salivary Cortisol Levels at time point 3.
Time frame: 1 month post intervention (Time point 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 15673629Denollet 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.
- Background: PubMed 12964174Connor 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.
- Ruden, R. (2011) When the Past is Always Present - Emotional Traumatisation, Causes, and Cures. USA: Routledge.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Hodgson principal investigator
Psychology Department, Cardiff Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosensory Therapy in people with Type D Personality and Trauma, Psychological, run by Cardiff Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.