Narrative Exposure Therapy for Adults With Intellectual Disability

NCT04418752 | Withdrawn

• 1 other identifier: 19101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTSD; Trauma, Psychological

Outcome Measures

Primary Outcomes (1)

• Change across the Impact of Events Scale-Intellectual Disabilities (IES-ID).

  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.

  Through study completion, up to 24 weeks - at baseline, at each NET session and six weeks after NET has been completed.

Secondary Outcomes (2)

• Change across the Clinical Outcome Routine Evaluation-Learning Disabilities (CORE-LD).

  Through study completion, up to 24 weeks - at baseline, at each NET session and six weeks after NET has been completed.

• Change across the Lancaster and Northgate Trauma Scales - Informant Version (LANTS-IV).

  Through study completion, up to 24 weeks - at baseline, at final session of NET and six weeks after NET has been completed.

Other Outcomes (2)

• Change across measures of Electrodermal activity (EDA)

  Through study completion, up to 24 weeks - throughout baseline sessions, throughout each NET session and throughout session six weeks after NET has been completed.

• Change across the narrative cohesion of participants accounts of traumatic experiences

  At the first and final session of NET - week 1 and week 12

Study Arms (1)

Psychological therapy

OTHER

Narrative Exposure Therapy will be delivered to all participants in the study except carer participants recruited to complete informant measures.

Other: Psychological therapy

Interventions

Psychological therapy OTHER

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.

Psychological therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be:
• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Related Publications (7)

• National Guideline Alliance (UK). Evidence reviews on care pathways for adults, children and young people with PTSD: Post-traumatic stress disorder: Evidence review J. London: National Institute for Health and Care Excellence (NICE); 2018 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK560231/

  PMID: 32757551 BACKGROUND

• 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.

  BACKGROUND

• Department of Health. (2005). Mental Capacity Act. Retrieved from https://www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpga_20050009_en.pdf

  BACKGROUND

• Hall JC, Jobson L, Langdon PE. Measuring symptoms of post-traumatic stress disorder in people with intellectual disabilities: the development and psychometric properties of the Impact of Event Scale-Intellectual Disabilities (IES-IDs). Br J Clin Psychol. 2014 Sep;53(3):315-32. doi: 10.1111/bjc.12048. Epub 2014 Mar 31.

  PMID: 24684206 BACKGROUND

• Wigham S, Hatton C, Taylor JL. The Lancaster and Northgate Trauma Scales (LANTS): the development and psychometric properties of a measure of trauma for people with mild to moderate intellectual disabilities. Res Dev Disabil. 2011 Nov-Dec;32(6):2651-9. doi: 10.1016/j.ridd.2011.06.008. Epub 2011 Jul 12.

  PMID: 21752595 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share