Traumatic Stress DisorderNCT05383846
Exposing Narrative Exposure Therapy
A study testing Experimental Narrative Exposure Therapy in people with Traumatic Stress Disorder, run by University of Nottingham at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Stress Disorder
- What is being tested?
- Experimental Narrative Exposure Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2022to 30 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham
Nottingham, Nottinghamshire, NG8 1BB
About this study
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).
Read the 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.
- Conditions
- Traumatic Stress Disorder
- Being tested
- Experimental Narrative Exposure Therapy
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Narrative Exposure TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Narrative Exposure Therapy | Experimental | 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. Receives: Other: Experimental Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Throughout intervention phase of the study, for approximately 24-28 weeks
Secondary outcomes (5)
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.
Measured: Throughout the study, for approximately 32 weeks ]
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.
Measured: Throughout the study, for approximately 32 weeks
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.
Measured: Throughout the intervention phase of the study, for approximately 24-28 weeks
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.
Measured: Throughout the intervention phase of the study, for approximately 24-28 weeks
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.
Measured: Throughout the intervention phase of the study, for approximately 24-28 weeks ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start14 Jan 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Stress DisorderStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Naturalistic, mixed-method, explanatory sequential measurement single case series design
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Sabin-Farrell, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383846
- Sponsor's protocol ID
- 21041
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposing Narrative Exposure Therapy
- ClinicalTrials.gov ID
- NCT05383846
- Acronym / sponsor ID
- 21041
- Conditions
- Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 20 May 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Naturalistic, mixed-method, explanatory sequential measurement single case series design
| Arm | Type | Receives |
|---|---|---|
| Experimental: Narrative Exposure Therapy | Experimental | Other: Experimental Narrative Exposure TherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Under the age of 18.
- Above the age of 65.
- Currently experiencing an episode of psychosis.
- Have an intellectual disability.
- Are actively suicidal.
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 |
|---|---|---|
| Experimental Narrative Exposure TherapyNET (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. | Other | Experimental: Narrative Exposure Therapy |
Primary outcome
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
Time frame: Throughout intervention phase of the study, for approximately 24-28 weeks
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).
5 secondary outcomes
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)
Time frame: Throughout the study, for approximately 32 weeks ]
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)
Time frame: Throughout the study, for approximately 32 weeks
Changes in heart rate and heart rate variability during the NET intervention, as assessed by the Polar H10 chest strap
Time frame: Throughout the intervention phase of the study, for approximately 24-28 weeks
Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)
Time frame: Throughout the intervention phase of the study, for approximately 24-28 weeks
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)
Time frame: Throughout the intervention phase of the study, for approximately 24-28 weeks ]
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 24 Aug 2023.
- 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.
Rachel Sabin-Farrell, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Narrative Exposure Therapy in people with Traumatic Stress Disorder, run by University of Nottingham 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 7 inclusion and 7 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 24 Aug 2023. 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 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 (time frame: Throughout intervention phase of the study, for approximately 24-28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.