Exposing Narrative Exposure Therapy
Primary Purpose
Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experimental Narrative Exposure Therapy
Sponsored by

About this trial
This is an interventional other trial for Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18-65
- Are able to give fully informed consent
- Experiencing traumatic stress resulting from multiple traumatic events (no formal diagnosis of PTSD/CPTSD is needed)
- Are able to communicate verbally and are fluent in English
- Have no on-going current trauma focused therapy
- Appropriate and ready for NET
- Referred to either Step 4 Psychological Services or Centre for Trauma
Exclusion Criteria:
- Under the age of 18.
- Above the age of 65.
- Currently experiencing an episode of psychosis.
- Have an intellectual disability.
- Are actively suicidal.
- Are non-fluent in English.
- Are currently abusing substances.
Sites / Locations
- The University of Nottingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Narrative Exposure Therapy
Arm Description
This is a multiple baseline single case series design which focuses on assessing the posited exposure and autobiographical memory integration components of Narrative Exposure Therapy; no comparator will be included.
Outcomes
Primary Outcome Measures
Change in autobiographical memory integration during NET intervention. A coding manual has been created by the research team to assess the posited mechanism of change- Autobiographical Memory Integration Coding Tool
A coding manual has been created by the research team to assess the posited mechanism of change.
The primary outcome (process) measure is autobiographical memory integration (ABMI) as this is a posited mechanism of change in NET. An existing coding measure (Jager et al., 2014; Lane, 2019) has been adapted for the purpose of the study, to include more areas measuring phenomenological constructs of autobiographical memory. The coding measure that has been created by the researcher will cover areas such as: Total word count of narratives (Gray & Lombardo, 2001); disorganisation (Harvey & Bryant, 1999)- repetition of phrases, confusion, and disjointedness; fragmentation (Foa et al., 1995)- unfinished thoughts, repetition of words, speech filler; vividness; time and place details; emotional distancing and sensory details (Boyacioglu & Akfirat, 2014). The measure will be used to code transcripts on a session-by-session basis and is therefore a process measure (primary aim of study).
Secondary Outcome Measures
Change in symptoms of post-traumatic stress disorder between the baseline, NET intervention, and up to 1 month follow-up phase- as assessed by the Impact of Events Scale Revised (IES-R; Weiss & Marmar, 1997)
The IES-R (Weiss & Marmar, 1997) will be used every session to assess symptoms of post-traumatic stress disorder. It is a 22 item self-report questionnaire, and is divided into three subscales, with 8 items on intrusion and avoidance: 6 on hyperarousal. The measure assesses Intrusion, avoidance and hyperarousal in PTSD over the last seven days. Answers on the measure ranges from 0 = Not at all; 1 = A little bit; 2 = Moderately; 3 = Quite a bit; 4 = Extremely, there are no specific cut off scores; however, scores over 24 indicate concern, with higher scores related to higher levels of distress.
Change in depression, anxiety, and stress between the baseline, NET intervention, and up to 1 month follow-up phase- as assessed by the Depression Anxiety and Stress Scale 21 (DAAS-21; Lovibond & Lovibond, 1995)
The DAAS-21 (Lovibond & Lovibond, 1995) will be used every session to assess depression, anxiety, and stress, it is a self-report questionnaire ranging over the last seven days. The DAAS-21 measures general psychological distress as an outcome measure (secondary aim of study). The measure consists of 21 items which are divided into 3 subscales with 7 questions for each subscale. Answers range on a scale from 0= Did not apply to me at all; 1= Applied to me to some degree, or some of the time; 2= Applied to me to a considerable degree or a good part of time; 3= Applied to me very much or most of the time. Scores of 10 and above on the depression sub scale indicates mild difficulties with depression; 8 and above on the anxiety sub-scale indicates mild difficulties with anxiety, and 15 and above on the stress sub-scale indicates mild difficulties with stress.
Changes in heart rate and heart rate variability during the NET intervention, as assessed by the Polar H10 chest strap
The Polar H10 chest strap will be used to collect heart rate data (heart rate- HR and heart rate variability- HRV). The Polar H10 has been shown to be a reliable and valid measure of HR and HRV; even when compared to an ECG as gold standard (Gilgen-Ammann et al., 2019; Speer et al., 2020). HRV measures physiological arousal and is the variation in time between heartbeats, by taking 5-minute segments of heart rate recordings, will allow for visual analysis of the root mean square of the successive differences between R-R intervals (rMSSD). HRV will be Measured every session pre- and post-narration and re-narration and used as a before and after measure to see how it changes over therapy.
Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)
The process of exposure and habituation are typically measured through Subjective Units of Distress Scale (SUDS; Foa & Kozack, 1986; Wolpe & Lazarus, 1966), which is a person's subjective account of distress on a set scale. Participants will be asked to rate their level of distress on a scale from 0 (no distress) to 10 (maximum distress), at the start, middle, and end of their trauma narrations. This is to see if how this relates to HR data.
Change in body awareness and autonomic reactivity during NET session, as assessed by the Body Perception Questionnaire Short Form - Autonomic Nervous System (Porges, 1993, 2015)
The Body Perception Questionnaire Short Form (BPQ-SF; Porges, 1993; Kolacz et al., 2018) is a 46 item self-report measure that assesses a person's perception of body awareness and autonomic reactivity. The measure's items are based on the autonomic nervous system, and a set of neural pathways that connect the brain and body. It assesses a person's experiences of reactivity in their organs and tissues that are regulated by the autonomic nervous system. . The first domain and subscale is body awareness with high scores reflecting hypersensitivity, whereas low scores reflect low hyposensitivity. The second domain, Autonomic Reactivity has two subscales, Supradiaphragmatic Reactivity which measures the responses of autonomically-innervated organs above the diaphragm. The second subscale Subdiaphragmatic Reactivity measures the response of autonomically-innervated gastrointestinal organs below the diaphragm.
Full Information
NCT ID
NCT05383846
First Posted
April 25, 2022
Last Updated
August 23, 2023
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT05383846
Brief Title
Exposing Narrative Exposure Therapy
Official Title
Exposing Narrative Exposure Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of the study is to further develop an existing measure of autobiographical memory integration (ABMI) to investigate and clarify the ABMI change process specific to narrative exposure therapy (NET).
Detailed Description
Traumas are events which include witnessing or being at the risk of, death, violence, and sexual violation. Experiencing trauma can lead to psychological and physiological changes, and an individual's mental health can deteriorate to the point where a diagnosis of Post-traumatic stress disorder (PTSD) is given; 10-20% of people develop enduring symptoms, with effective treatment being a challenge.
While being exposed to trauma does not lead to PTSD, there is a dose-response relationship between the severity and duration of traumatic events and developing PTSD, suggesting that more complex forms of PTSD can develop if a person is subjected to multiple traumatic events. Complex post-traumatic stress disorder (CPTSD) occurs when a person is subjected to multiple prolonged traumas of an interpersonal nature, where escape is impossible. Different treatment approaches are needed for PTSD and CPTSD.
One therapy which has received support for treating CPTSD is Narrative Exposure Therapy (NET). NET is a National Institute for Health and Care Excellence recommended short-term manualised therapy. NET appears to be a well-tolerated treatment and has consistently low attrition rates when compared to other therapies. There is also emerging evidence of NET's effectiveness in the general population. The central aim of NET treatment is re-integration of contextual information and the traumatic memory into an autobiographical lifeline; this occurs through narrating the memory and involves prolonged exposure and habituation, and integration of the trauma memory into an autobiographical context. Despite NET's successes, its mechanisms of change have not been evidenced empirically, especially the element of contextualisation and integration of trauma into autobiographical memory (ABM). Four participants will be recruited with the support of local staff working in mental health services across Nottinghamshire. Participants will receive between twelve to fourteen weekly interventions sessions. Changes will be explored through process and outcome measures administered before, during, and after the intervention and interviews will be conducted at the end to gather participants experiences.
The study is supported by The University of Nottingham. Potential benefits include providing participants with an intervention to resolve their trauma and also to provide a theoretical contribution by either proving or refuting the process measures posted by NET.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Stress Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Naturalistic, mixed-method, explanatory sequential measurement single case series design
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
This is a multiple baseline single case series design which focuses on assessing the posited exposure and autobiographical memory integration components of Narrative Exposure Therapy; no comparator will be included.
Intervention Type
Other
Intervention Name(s)
Experimental Narrative Exposure Therapy
Intervention Description
NET (Schauer et al., 2011) is an evidence-based, short-term, manualised treatment for complex trauma, aiming to reduce symptoms of traumatic stress in individuals. NET combines principles of CBT, Testimony Therapy, and Exposure Therapy.
This is a multiple baseline single case series design which focuses on assessing the posited exposure and autobiographical memory integration components of Narrative Exposure Therapy; no comparator will be included.
Primary Outcome Measure Information:
Title
Change in autobiographical memory integration during NET intervention. A coding manual has been created by the research team to assess the posited mechanism of change- Autobiographical Memory Integration Coding Tool
Description
A coding manual has been created by the research team to assess the posited mechanism of change.
The primary outcome (process) measure is autobiographical memory integration (ABMI) as this is a posited mechanism of change in NET. An existing coding measure (Jager et al., 2014; Lane, 2019) has been adapted for the purpose of the study, to include more areas measuring phenomenological constructs of autobiographical memory. The coding measure that has been created by the researcher will cover areas such as: Total word count of narratives (Gray & Lombardo, 2001); disorganisation (Harvey & Bryant, 1999)- repetition of phrases, confusion, and disjointedness; fragmentation (Foa et al., 1995)- unfinished thoughts, repetition of words, speech filler; vividness; time and place details; emotional distancing and sensory details (Boyacioglu & Akfirat, 2014). The measure will be used to code transcripts on a session-by-session basis and is therefore a process measure (primary aim of study).
Time Frame
Throughout intervention phase of the study, for approximately 24-28 weeks
Secondary Outcome Measure Information:
Title
Change in symptoms of post-traumatic stress disorder between the baseline, NET intervention, and up to 1 month follow-up phase- as assessed by the Impact of Events Scale Revised (IES-R; Weiss & Marmar, 1997)
Description
The IES-R (Weiss & Marmar, 1997) will be used every session to assess symptoms of post-traumatic stress disorder. It is a 22 item self-report questionnaire, and is divided into three subscales, with 8 items on intrusion and avoidance: 6 on hyperarousal. The measure assesses Intrusion, avoidance and hyperarousal in PTSD over the last seven days. Answers on the measure ranges from 0 = Not at all; 1 = A little bit; 2 = Moderately; 3 = Quite a bit; 4 = Extremely, there are no specific cut off scores; however, scores over 24 indicate concern, with higher scores related to higher levels of distress.
Time Frame
Throughout the study, for approximately 32 weeks ]
Title
Change in depression, anxiety, and stress between the baseline, NET intervention, and up to 1 month follow-up phase- as assessed by the Depression Anxiety and Stress Scale 21 (DAAS-21; Lovibond & Lovibond, 1995)
Description
The DAAS-21 (Lovibond & Lovibond, 1995) will be used every session to assess depression, anxiety, and stress, it is a self-report questionnaire ranging over the last seven days. The DAAS-21 measures general psychological distress as an outcome measure (secondary aim of study). The measure consists of 21 items which are divided into 3 subscales with 7 questions for each subscale. Answers range on a scale from 0= Did not apply to me at all; 1= Applied to me to some degree, or some of the time; 2= Applied to me to a considerable degree or a good part of time; 3= Applied to me very much or most of the time. Scores of 10 and above on the depression sub scale indicates mild difficulties with depression; 8 and above on the anxiety sub-scale indicates mild difficulties with anxiety, and 15 and above on the stress sub-scale indicates mild difficulties with stress.
Time Frame
Throughout the study, for approximately 32 weeks
Title
Changes in heart rate and heart rate variability during the NET intervention, as assessed by the Polar H10 chest strap
Description
The Polar H10 chest strap will be used to collect heart rate data (heart rate- HR and heart rate variability- HRV). The Polar H10 has been shown to be a reliable and valid measure of HR and HRV; even when compared to an ECG as gold standard (Gilgen-Ammann et al., 2019; Speer et al., 2020). HRV measures physiological arousal and is the variation in time between heartbeats, by taking 5-minute segments of heart rate recordings, will allow for visual analysis of the root mean square of the successive differences between R-R intervals (rMSSD). HRV will be Measured every session pre- and post-narration and re-narration and used as a before and after measure to see how it changes over therapy.
Time Frame
Throughout the intervention phase of the study, for approximately 24-28 weeks
Title
Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)
Description
The process of exposure and habituation are typically measured through Subjective Units of Distress Scale (SUDS; Foa & Kozack, 1986; Wolpe & Lazarus, 1966), which is a person's subjective account of distress on a set scale. Participants will be asked to rate their level of distress on a scale from 0 (no distress) to 10 (maximum distress), at the start, middle, and end of their trauma narrations. This is to see if how this relates to HR data.
Time Frame
Throughout the intervention phase of the study, for approximately 24-28 weeks
Title
Change in body awareness and autonomic reactivity during NET session, as assessed by the Body Perception Questionnaire Short Form - Autonomic Nervous System (Porges, 1993, 2015)
Description
The Body Perception Questionnaire Short Form (BPQ-SF; Porges, 1993; Kolacz et al., 2018) is a 46 item self-report measure that assesses a person's perception of body awareness and autonomic reactivity. The measure's items are based on the autonomic nervous system, and a set of neural pathways that connect the brain and body. It assesses a person's experiences of reactivity in their organs and tissues that are regulated by the autonomic nervous system. . The first domain and subscale is body awareness with high scores reflecting hypersensitivity, whereas low scores reflect low hyposensitivity. The second domain, Autonomic Reactivity has two subscales, Supradiaphragmatic Reactivity which measures the responses of autonomically-innervated organs above the diaphragm. The second subscale Subdiaphragmatic Reactivity measures the response of autonomically-innervated gastrointestinal organs below the diaphragm.
Time Frame
Throughout the intervention phase of the study, for approximately 24-28 weeks ]
Other Pre-specified Outcome Measures:
Title
Change Interviews (Elliot et al., 2001)
Description
The feasibility and acceptability of the study will be investigated by conducting follow up change interviews with participants approximately one month after completing the treatment. In this instance, the participant will be asked to provide feedback on their experience of receiving treatment, including in terms of barriers and fascinators to engagement. The interviews will be conducted by an external researcher, i.e. another Trainee Clinical Psychologist. The interviews will be recorded and sent to the researcher and they will then be transcribed, after transcription content analysis will be applied to them.
Time Frame
At 1 month follow up
Title
Number of Traumatic Events- The Life Events Checklist (Weathers et al., 2013).
Description
The Life Events Checklist (LEC-5) which is part of the PCL-5 will be used in the proposed study. The LEC-5 is not an outcome measure but will be used to assess the number and type of traumatic events a person has experienced which is being collected as demographic information.
Time Frame
1 week at consent session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18-65
Are able to give fully informed consent
Experiencing traumatic stress resulting from multiple traumatic events (no formal diagnosis of PTSD/CPTSD is needed)
Are able to communicate verbally and are fluent in English
Have no on-going current trauma focused therapy
Appropriate and ready for NET
Referred to either Step 4 Psychological Services or Centre for Trauma
Exclusion Criteria:
Under the age of 18.
Above the age of 65.
Currently experiencing an episode of psychosis.
Have an intellectual disability.
Are actively suicidal.
Are non-fluent in English.
Are currently abusing substances.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Sabin-Farrell, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG8 1BB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Exposing Narrative Exposure Therapy
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