- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934109
Narrative Exposure Therapy for Adults With an Intellectual Disability
Acceptability and Feasibility of an Adapted Narrative Exposure Therapy (NET) Protocol for Individuals With an Intellectual Disability
The goal of this naturalistic single case series design is to investigate if an adapted Narrative Exposure Therapy protocol can be effective, is feasible, and acceptable for adults with a mile learning disability.
Participants will be complete three baseline sessions before taking part in Narrative Exposure Therapy using a manual that has been adapted for people with a learning disability. Trauma symptoms will be measured weekly using the Impact of Events scale adapted for intellectual disabilities. The person's carer will also complete an informant scale related to these symptoms (LANTS-IV). The client will also complete the CORE-LD at pre, and post therapy. Six weeks after the end of the intervention, the client and their carer will be invited to a feedback session to talk about how they found the intervention.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nottingham, United Kingdom, NG3 6AA
- Nottinghamshire Healthcare NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 and over
- Meet the criteria for having a mild ID as assessed by a clinical psychologist within the team
- English speaking
- Have capacity to consent
- The participant must be experiencing trauma related stress as assessed by themselves, the clinical psychologist and the research team
- Be able to travel to one of the therapy sites
- Carer participant must have ability to reflect and comment on the trauma related stress experienced by the client participant
- Carer must also be 18 years old or older and be English speaking.
- Carer must have known participant for 1 year or more.
Exclusion Criteria:
- They are substance dependent
- They are currently receiving another trauma-focused intervention
- Currently an inpatient
- Carers excluded if they lack capacity to consent to take part in research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Narrative Exposure Therapy treatment
All participants within the trial will receive narrative exposure therapy and be within the treatment arm.
|
NET is a psychological talking therapy that has been designed for people who have experienced multiple and prolonged traumatic experiences.
It is typically 12-sessions, involving first a psychoeducation session, then laying a lifeline where stones are lain to represent traumatic events, and flowers positive life events.
The following sessions the person is asked to talk through their life, going into detail on the traumatic memories that they have experienced.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Events Scale for intellectual disabilities (IES-ID)
Time Frame: Completed weekly through baseline and intervention stages, approximately 16 weeks. Then at 6-week follow up (approximately week 22).
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The IES-ID (Hall et al., 2014) is a 22 item scale scored on a three-point Likert scale measuring trauma related symptoms.
This is an adapted measure that has been validated for people with an intellectual disability.
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Completed weekly through baseline and intervention stages, approximately 16 weeks. Then at 6-week follow up (approximately week 22).
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Lancaster and Northgate Trauma Scale for Intellectual Disabilities - Informant Version (LANTS-IV; Wigham et al., 2011)
Time Frame: Completed weekly through baseline and intervention stages, approximately 16 weeks. Then at 6-week follow up (approximately week 22).
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47 scored on a six-point scale for frequency and three-point for severity.
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Completed weekly through baseline and intervention stages, approximately 16 weeks. Then at 6-week follow up (approximately week 22).
|
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Clinical Outcome Routine Evaluation-Learning Disabilities (CORE-LD; Brooks et al., 2013)
Time Frame: At baseline week 1 and at 6-week follow-up (approximately week 22).
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14 scored on a three-point Likert scale measuring psychological distress across four domains: well-being, symptoms, functioning, and risk
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At baseline week 1 and at 6-week follow-up (approximately week 22).
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Change interview (Elliott et al., 2001) with clients and carers
Time Frame: 6-weeks post-intervention. Sessions will be around 30-60 minutes.
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A feedback session will be held with the client and their carer around 6-weeks after the therapy has come to an end.
This will ask for feedback on how they found the intervention.
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6-weeks post-intervention. Sessions will be around 30-60 minutes.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart rate
Time Frame: Weekly during the intervention sessions, for approximately 12-weeks.
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Heart rate will be taken using a fitness watch that can measure continuous heart rate.
This will show whether any within and between session habituation has taken place.
Subjective units of distress (Wolpe, 1969) will be used if clients do not wish to wear a heart rate device.
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Weekly during the intervention sessions, for approximately 12-weeks.
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Post-session therapist reflections
Time Frame: Across the intervention phase, an average of a year
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Therapist reflections will be collected to gather information about their thoughts relating to the manual and therapy.
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Across the intervention phase, an average of a year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Schroder, University of Nottingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neurobehavioral Manifestations
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neurodevelopmental Disorders
- Lymphoma
- Communication Disorders
- Stress Disorders, Traumatic
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Psychological Trauma
- Lymphoma, Follicular
- Intellectual Disability
- Learning Disabilities
- Stress Disorders, Post-Traumatic
Other Study ID Numbers
- 24042
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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