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| Name | Class |
|---|---|
| University of East Anglia | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Treatment) | Experimental | A treatment group cohort who have self-referred for the psychosensory therapy intervention (Havening Techniques). |
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| Control Group (Waiting List) | No Intervention | Self-referral waiting list cohort (usual care). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in the Connor-Davidson Resilience Scale (CD-RISC) score at time point 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsty Hodgson | Psychology Department, Cardiff Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychology Department | Cardiff | Wales | CF5 2YB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15673629 | Background | 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. | |
| 12964174 | 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. |
| Label | URL |
|---|---|
| Ruden, R. (2011) When the Past is Always Present - Emotional Traumatisation, Causes, and Cures. USA: Routledge. | View source |
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| ID | Term |
|---|---|
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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A researcher-blind parallel-group controlled psychosomatic therapy intervention trial.
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Coded-analysis group allocation and database - blind to allocation.
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Repeat assessment of co-primary outcome measure 2.
| 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 1 month post intervention (Time point 3) |