Clinical trial NCT03966963: Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors
Official title: A Systematic Case Series Study Investigating the Effectiveness of Eye Movement Desensitization Reprocessing (EMDR) in the Treatment of Childhood Sexual Abuse in Adolescents and Adult Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma, Psychological
Keywords: Eye Movement Desensitization Reprocessing; EMDR
childhood sexual abuse
posttraumatic stress disorder
PTSD
adults
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed methods study
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse. All participants will undertake a standard course of EMDR via the National Heath Service program, alongside a number of questionnaires and a follow-up interview.

Detailed description: The aim of this study is to investigate the effectiveness of Eye Movement Desensitisation Reprocessing (EMDR) via investigation of the changes in the individual trauma stress response on sexually abused adolescents and young adults, aged between 18 and 25 during EMDR treatment. The findings of this mixed methods study will explore (a) neuropsychological, emotional (namely low self-esteem, anxiety and depression), behavioural functioning and quality of life issues via quantitative measures conducted before, during and after treatment and (b) client perspectives of such changes through qualitative interviewing (interview guide is in Appendix 7) at one month follow-up using Interpretative Phenomenological Analysis \[IPA\]. The study setting will be conducted within the Improving Access to Psychological Therapies (IAPT) program framework, established to ensure service users accessing NHS treatment are presented with choice in their treatment. Therapy will routinely be delivered within GP Surgeries or Health Centres.

Within this two-fold study, the following key research questions will be considered in relation to the effectiveness of EMDR:

1. Qualitative data will sought to identify; In what ways was EMDR helpful? In what ways was EMDR perceived as being unhelpful?
2. Quantitative data will sought to identify; Are there changes in emotional and behavioural functioning (in relation to trauma, anxiety and depressive symptoms)? Are there changes in neuropsychological functioning (memory, attention, executive functioning)? Are there changes in quality of life issues? Are there changes in self-worth?

Eligibility criteria: Inclusion Criteria:

Participants, both male and female, aged between 18 and 25, whom;

* have experienced CSA before the age of 16
* exhibit PTSD symptomology
* ensure PTSD symptomology is present for over three-months and primarily derived from pre-16 aged trauma
* be available for treatment-sessions on a weekly basis for up to 16-sessions - have good understanding of the English language to avoid language barriers/additional time spent with interpreters
* if taking medication, this will have been stable for a period of at least 2-months prior to therapy
* EMDR is the sole treatment for PTSD from baseline until follow-up to avoid conflict of interest

Exclusion Criteria:

Participants exhibiting;

* significant psychiatric comorbidity
* comorbid psychotic disorder
* bipolar disorder type 1
* alcohol or drug dependence
* acute suicide risk, acute PTSD from trauma within the past 6 months
* PTSD focused treatment within the past 3 months or scheduled to begin another form of PTSD treatment will be excluded
* those currently participating in research or have recently participated in conflicting research

Primary outcomes:
measure: Impact of Events Scale-Revised 'IESR'
timeFrame: Change from Baseline PTSD symptomology at up to 5 months
measure: The Psychology Experiment Building Language 'PEBL' Test
timeFrame: Change from Baseline neuropsychological functioning at up to 5 months
measure: Generalized Anxiety Disorder 7 (GAD-7) Scale
timeFrame: Change from Baseline anxiety levels at up to 5 months
measure: Patient Health Questionnaire 9 (PHQ-9) Scale
timeFrame: Change from Baseline depression levels at up to 5 months
measure: Weekly Problems Rating Scale
timeFrame: Change from Baseline emotional and behavioural functioning at up to 5 months
measure: Rosenberg Self-Esteem Scale 'RSES'
timeFrame: Change from Baseline levels of self-worth at up to 5 months
measure: The Valued Living Questionnaire 'VLQ'
timeFrame: Change from Baseline quality of life issues at up to 5 months
Secondary outcomes:
measure: Helpful Aspects of Therapy Interview
timeFrame: One-month follow up
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Trust (GMMH - IAPT Headquarters, Chorlton House)
state: Greater Manchester
Study officials:
affiliation: University of Salford
name: Linda Dubrow-Marshall
role: STUDY_CHAIR
affiliation: University of Salford
name: Clare S Allely
role: STUDY_CHAIR
References:
citation: Brown SJ, Carter GJ, Halliwell G, Brown K, Caswell R, Howarth E, Feder G, O'Doherty L. Survivor, family and professional experiences of psychosocial interventions for sexual abuse and violence: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD013648. doi: 10.1002/14651858.CD013648.pub2.