- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966963
Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors (EMDR)
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 Overview
Status
Conditions
Intervention / Treatment
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:
- Qualitative data will sought to identify; In what ways was EMDR helpful? In what ways was EMDR perceived as being unhelpful?
- 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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M219UN
- Greater Manchester Mental Health NHS Trust (GMMH - IAPT Headquarters, Chorlton House)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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: Eye Movement Desensitization Reprocessing (EMDR)
Subjects with trauma-related symptomology resultant from CSA will undertake EMDR; they will be systematically observed through use of their quantitative treatment outcome measures at both pre- and post- treatment alongside one-month follow-up interview data to determine outcomes of interest (namely emotional, behavioural and neuropsychological functioning).
|
Trauma-Focused Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Events Scale-Revised 'IESR'
Time Frame: Change from Baseline PTSD symptomology at up to 5 months
|
22-item self-report measure to evaluate impact of sexual abuse in terms of traumatic stress, abuse attributions and social reactions.
Participants will be asked to rate their level of distress in relation to the said traumatic event on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"), ultimately providing the researcher with a total score (ranging from 0 to 88).
The higher the score, the greater the PTSD symptomology.
|
Change from Baseline PTSD symptomology at up to 5 months
|
The Psychology Experiment Building Language 'PEBL' Test
Time Frame: Change from Baseline neuropsychological functioning at up to 5 months
|
The PEBL is an electronic neuropsychological battery utilised to monitor adaptations in participants' neuropsychological functioning.
|
Change from Baseline neuropsychological functioning at up to 5 months
|
Generalized Anxiety Disorder 7 (GAD-7) Scale
Time Frame: Change from Baseline anxiety levels at up to 5 months
|
Participants will be asked to rate their level of anxiety on a 7-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), ultimately providing the researcher with a total score (ranging from 0 to 21).
The higher the score, the greater the anxiety.
|
Change from Baseline anxiety levels at up to 5 months
|
Patient Health Questionnaire 9 (PHQ-9) Scale
Time Frame: Change from Baseline depression levels at up to 5 months
|
Participants will be asked to rate their level of depression on a 9-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), ultimately providing the researcher with a total score (ranging from 0 to 27).
The higher the score, the greater the depression.
|
Change from Baseline depression levels at up to 5 months
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Weekly Problems Rating Scale
Time Frame: Change from Baseline emotional and behavioural functioning at up to 5 months
|
This consists of 11 statements that participants are requested to rate in order to describe their feelings and interactions during the past week to gauge general emotional and behavioural functioning.
Answers/statements for all questions are from a choice of the following "never" "almost never" "a little of the time" "some of the time" "most of the time" "all of the time."
Generally, the more negative the selected statement, the greater the indication of issues in functioning within that given domain.
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Change from Baseline emotional and behavioural functioning at up to 5 months
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Rosenberg Self-Esteem Scale 'RSES'
Time Frame: Change from Baseline levels of self-worth at up to 5 months
|
The 10-item RSES measures global self-worth by measuring both positive and negative feelings about the self.
Participants will be asked to rate their level of self-worth by measuring both positive and negative feelings about the self.
All items are answered using a 4-point Likert scale format as follows; "Strongly Disagree" 1 point, "Disagree" 2 points, "Agree" 3 points, and "Strongly Agree" 4 points,' ultimately providing the researcher with a total score (ranging from 10 to 40).
Higher scores indicate higher self-esteem.
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Change from Baseline levels of self-worth at up to 5 months
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The Valued Living Questionnaire 'VLQ'
Time Frame: Change from Baseline quality of life issues at up to 5 months
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The VLQ is an instrument that taps into 10 valued domains of living as follows; 1. Family, 2. Marriage/couples/intimate relations, 3. Parenting, 4. Friendship, 5. Work, 6. Education, 7. Recreation, 8. Spirituality, 9. Citizenship, and 10.
Physical self-care.
Scoring: Respondents are asked to rate the 10 areas of life on a scale of 1 (not at all important) -10 (extremely important), indicating the level of importance and how consistently they have lived in accord with those values in the past week, ultimately providing the researcher with a total score (ranging from 10 to 100).
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Change from Baseline quality of life issues at up to 5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Helpful Aspects of Therapy Interview
Time Frame: One-month follow up
|
A qualitative semi-structured interview at one-month follow up.
The first seven questions of which will help identify helpful/unhelpful aspects of therapy and the final four questions focusing on effectiveness, ending and any recommendations for treatment.
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One-month follow up
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Linda Dubrow-Marshall, University of Salford
- Study Chair: Clare S Allely, University of Salford
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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