NCT05383846

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

August 24, 2023

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

April 25, 2022

Last Update Submit

August 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    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)

    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)

    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

    Throughout the intervention phase of the study, for approximately 24-28 weeks

  • Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)

    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)

    Throughout the intervention phase of the study, for approximately 24-28 weeks ]

Other Outcomes (2)

  • Change Interviews (Elliot et al., 2001)

    At 1 month follow up

  • Number of Traumatic Events- The Life Events Checklist (Weathers et al., 2013).

    1 week at consent session

Study Arms (1)

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.

Other: Experimental Narrative Exposure Therapy

Interventions

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.

Experimental: Narrative Exposure Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Nottingham

Nottingham, Nottinghamshire, NG8 1BB, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Rachel Sabin-Farrell, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Naturalistic, mixed-method, explanatory sequential measurement single case series design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 20, 2022

Study Start

January 14, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

August 24, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations