Clinical trial NCT05383846: Exposing Narrative Exposure Therapy
Official title: Exposing Narrative Exposure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Stress Disorder
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Naturalistic, mixed-method, explanatory sequential measurement single case series design
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18-65
2. Are able to give fully informed consent
3. Experiencing traumatic stress resulting from multiple traumatic events (no formal diagnosis of PTSD/CPTSD is needed)
4. Are able to communicate verbally and are fluent in English
5. Have no on-going current trauma focused therapy
6. Appropriate and ready for NET
7. Referred to either Step 4 Psychological Services or Centre for Trauma

Exclusion Criteria:

1. Under the age of 18.
2. Above the age of 65.
3. Currently experiencing an episode of psychosis.
4. Have an intellectual disability.
5. Are actively suicidal.
6. Are non-fluent in English.
7. Are currently abusing substances.

Primary outcomes:
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
timeFrame: Throughout intervention phase of the study, for approximately 24-28 weeks
Secondary outcomes:
measure: 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)
timeFrame: Throughout the study, for approximately 32 weeks ]
measure: 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)
timeFrame: Throughout the study, for approximately 32 weeks
measure: Changes in heart rate and heart rate variability during the NET intervention, as assessed by the Polar H10 chest strap
timeFrame: Throughout the intervention phase of the study, for approximately 24-28 weeks
measure: Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)
timeFrame: Throughout the intervention phase of the study, for approximately 24-28 weeks
measure: 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)
timeFrame: Throughout the intervention phase of the study, for approximately 24-28 weeks ]
Other outcomes:
measure: Change Interviews (Elliot et al., 2001)
timeFrame: At 1 month follow up
measure: Number of Traumatic Events- The Life Events Checklist (Weathers et al., 2013).
timeFrame: 1 week at consent session
Locations:
city: Nottingham
country: United Kingdom
facility: The University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Rachel Sabin-Farrell, PhD
role: PRINCIPAL_INVESTIGATOR
References: