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Narrative Exposure Therapy for Adults With Intellectual Disability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418752
Recruitment Status : Withdrawn (The study is no longer feasible due to the restrictions placed on access to potential participants during the COVID-19 pandemic.)
First Posted : June 5, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

The purpose of the study is to identify how Narrative Exposure Therapy (NET) can be adapted for delivery with adults with mild Intellectual Disability (ID) and to explore whether NET can reduce symptoms of traumatic stress in this population.

The first phase of the research involves working with a speech and language therapist to make adaptations to the therapy and research materials for adults with mild ID. This work will then be triangulated by gaining feedback from a service user focus group on the accessibility of materials for adults with mild ID.

The second phase of the research consists of a 'sequential measurement single case studies series' to explore the effectiveness of Narrative Exposure Therapy (NET) in reducing symptoms of PTSD or prominent symptoms. Questionnaires will be completed before, during and after the therapy by both the adult with ID and a carer if possible and consenting. Electrodermal activity of participants will be measured throughout sessions (using an unobtrusive device) as an indicator of physiological arousal. All measures will be visually analysed using established criteria and statistical methods where possible. The impact of NET on a person's memory of events in their life will be explored by examining how coherent participants' accounts of traumatic experiences are before and after NET using coding systems developed by previous studies. An interview will take place approximately six weeks after therapy with the participant by an independent researcher. This will aim to collect qualitative data about the participants' experiences of NET and will be analysed using content analysis.

Participants will be recruited primarily from Intellectual Disability services in Nottinghamshire Healthcare NHS Foundation Trust. This will be extended to Derbyshire Healthcare NHS Foundation Trust and Lincolnshire Partnership NHS Foundation Trust if necessary (Secondary care). The investigators intend to recruit six participants and six carers to the study.


Condition or disease Intervention/treatment Phase
PTSD Trauma, Psychological Other: Psychological therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The second phase of the research consists of a Sequential Measurement Single Case Study Series (SMSCSS) to explore the effectiveness of NET in reducing symptoms of traumatic stress in adults with ID. This requires measures to be completed at various time points across the research by both participants and carers. Inferences can then be made about changes in behaviour as a result of the therapy, particularly when a stable baseline has been established. In a naturalistic clinical setting, such as the current research, it is difficult to gain a stable baseline as the investigators would expect the potential for some change to occur in anticipation of the therapy. The investigators aim to collect three baseline measures prior to NET commencing; however, the investigators do not want to withhold therapy and risk attrition to obtain a stable baseline.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Narrative Exposure Therapy for Traumatic Stress in Adults With Intellectual Disabilities: A Sequential Measurement Single Case Study Series
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Psychological therapy
Narrative Exposure Therapy will be delivered to all participants in the study except carer participants recruited to complete informant measures.
Other: Psychological therapy
The National Institute for Health and Care Excellence (2018) specifies NET as a psychological intervention for the treatment of PTSD or prominent symptoms of PTSD in adults. NET is a short-term treatment which incorporates elements of CBT exposure therapy and testimonial therapy. In exposure therapy, clients are encouraged to repeatedly discuss traumatic experiences in detail, including emotions and sensory experiences (Schauer, Elbert, & Neuner, 2011).Testimonial therapy involves "the construction of a detailed and coherent report of the survivor's biography including an explicit description of the traumatic events" (Neuner, Schauer, Roth & Elbert, 2002, pp.5-6). Therefore, NET aims to embed the traumatic experience within the context of the person's life and the mechanisms of change are theorised to be exposure and habituation to the traumatic experience and the reconstruction of autobiographical memory.




Primary Outcome Measures :
  1. Change across the Impact of Events Scale-Intellectual Disabilities (IES-ID). [ Time Frame: Through study completion, up to 24 weeks - at baseline, at each NET session and six weeks after NET has been completed. ]
    The IES-ID is a 22-item questionnaire scored on a three-point scale. It is designed for use with people with mild ID and measures symptoms of traumatic stress; higher scores indicate higher levels of traumatic stress. The authors found the scale to have excellent internal consistency, good to excellent test-retest reliability and good correlation with self-report measures of anxiety and depression.


Secondary Outcome Measures :
  1. Change across the Clinical Outcome Routine Evaluation-Learning Disabilities (CORE-LD). [ Time Frame: Through study completion, up to 24 weeks - at baseline, at each NET session and six weeks after NET has been completed. ]
    The CORE-LD is a 14-item questionnaire scored on a three-point scale for use with adults with ID receiving any form of psychological therapy; higher scores indicate higher levels of psychological distress. Within a sample of individuals with mild and moderate ID, the authors found the CORE-LD to be a valid measure with good test-retest reliability. The measure has been chosen as it captures general psychological distress and the unrevised version is widely used in NHS settings.

  2. Change across the Lancaster and Northgate Trauma Scales - Informant Version (LANTS-IV). [ Time Frame: Through study completion, up to 24 weeks - at baseline, at final session of NET and six weeks after NET has been completed. ]
    The LANTS-IV is a 43-item questionnaire completed by informants of adults with ID. It consists of a list of statements describing behaviours which may be exhibited by adults with ID who have experienced traumatic events. Informants are asked to rate each statement in terms of frequency on a six-point scale and severity on a three-point scale; higher scores indicate higher trauma related presentations. Within a sample of individuals with mild and moderate ID, the authors found the measure to have good internal reliability, test-retest reliability and construct validity. The LANTS-IV has been chosen as the investigators anticipate and encourage carer involvement in this research.


Other Outcome Measures:
  1. Change across measures of Electrodermal activity (EDA) [ Time Frame: Through study completion, up to 24 weeks - throughout baseline sessions, throughout each NET session and throughout session six weeks after NET has been completed. ]
    EDA will be measured using the Mindfield eSense Skin Response device - this measures skin conductance as an indicator of physiological arousal. Higher levels of EDA indicates higher levels of physiological arousal.

  2. Change across the narrative cohesion of participants accounts of traumatic experiences [ Time Frame: At the first and final session of NET - week 1 and week 12 ]
    The narrative cohesion of participants accounts of traumatic experiences at the start and end of NET using coding systems developed by previous studies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants must be:

  • 18 or over (no upper age limit due to ID services being lifelong).
  • deemed to meet criteria for a mild intellectual disability, according to the clinical psychologist supporting recruitment.
  • Experiencing traumatic stress, as assessed by their clinical psychologist using the Impact of Events Scale - Intellectual Disabilities. Traumatic stress will be a feature of their presenting problems but they are not required to have a diagnosis of PTSD (NET recommended to treat prominent symptoms also).
  • English speaking.
  • Able to travel to one of the therapy centres.
  • Able to consent to the research, as assessed by both the clinical psychologist supporting recruitment and the student delivering NET.

Carer participants must be:

  • 18 or over (no upper age limit).
  • English speaking to undertake informant questionnaires.
  • Able to comment on the symptoms of traumatic stress experienced daily by the participant.

Exclusion Criteria:

Participants will be excluded if they are:

  • Substance dependent (NET requires participants to process traumatic experiences in detail; often substances are used as a way to block out these memories and therefore may impact on the therapy).
  • Experiencing psychosis as assessed by both the clinical psychologist supporting recruitment and the student delivering NET.
  • Currently an inpatient (NET at this time would be inappropriate due to challenging behaviour/level of illness).
  • Currently engaging in a trauma-focused therapy with their psychologist (it would not be appropriate to interrupt potentially beneficial treatment).
  • Currently engaging in other research projects (this would burden the participant and depending on the nature may affect results of this project).

Carer participants will be excluded if:

• They lack capacity to consent to take part in the research, as assessed by both the clinical psychologist supporting recruitment and the student delivering NET.

Publications:
National Institute for Health and Care Excellence. (2018). Post-traumatic stress disorder. Retrieved from https://www.nice.org.uk/guidance/ng116/chapter/Recommendations#management-of-ptsd-in-children-young-people-and-adults
Mevissen, L., Didden, R., & de Jongh, A. (2016). Assessment and treatment of PTSD in people with intellectual disabilities. Comprehensive guide to post-traumatic stress disorders, 281-299.
Department of Health. (2005). Mental Capacity Act. Retrieved from https://www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpga_20050009_en.pdf
Brooks, M., Davies, S., & Twigg, E. (2013). A measure for feelings-using inclusive research to develop a tool for evaluating psychological therapy (Clinical Outcomes in Routine Evaluation-Learning Disability). British Journal of Learning Disabilities, 41(4), 320-329.
Fletcher, R. J., Barnhill, J., McCarthy, J., & Strydom, A. (2016). From DSM to DM-ID. Journal of Mental Health Research in Intellectual Disabilities, 9(3), 189-204.

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04418752    
Other Study ID Numbers: 19101
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be written up in a peer-reviewed journal and as part of a Doctoral Thesis. Individual participant data will be anonymised. Should a request be made for individualised data, this would have to be approved by the various ethical and research boards involved.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intellectual Disability
Psychological Trauma
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders