search
Back to results

Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors (EMDR)

Primary Purpose

Trauma, Psychological

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Eye Movement Desensitization Reprocessing (EMDR)
Sponsored by
University of Salford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Psychological focused on measuring Eye Movement Desensitization Reprocessing; EMDR, childhood sexual abuse, posttraumatic stress disorder, PTSD, adults

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Greater Manchester Mental Health NHS Trust (GMMH - IAPT Headquarters, Chorlton House)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eye Movement Desensitization Reprocessing (EMDR)

Arm Description

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).

Outcomes

Primary Outcome Measures

Impact of Events Scale-Revised 'IESR'
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.
The Psychology Experiment Building Language 'PEBL' Test
The PEBL is an electronic neuropsychological battery utilised to monitor adaptations in participants' neuropsychological functioning.
Generalized Anxiety Disorder 7 (GAD-7) Scale
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.
Patient Health Questionnaire 9 (PHQ-9) Scale
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.
Weekly Problems Rating Scale
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.
Rosenberg Self-Esteem Scale 'RSES'
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.
The Valued Living Questionnaire 'VLQ'
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).

Secondary Outcome Measures

Helpful Aspects of Therapy Interview
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.

Full Information

First Posted
May 22, 2019
Last Updated
April 27, 2021
Sponsor
University of Salford
search

1. Study Identification

Unique Protocol Identification Number
NCT03966963
Brief Title
Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors
Acronym
EMDR
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological
Keywords
Eye Movement Desensitization Reprocessing; EMDR, childhood sexual abuse, posttraumatic stress disorder, PTSD, adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mixed methods study
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye Movement Desensitization Reprocessing (EMDR)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization Reprocessing (EMDR)
Intervention Description
Trauma-Focused Therapy
Primary Outcome Measure Information:
Title
Impact of Events Scale-Revised 'IESR'
Description
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.
Time Frame
Change from Baseline PTSD symptomology at up to 5 months
Title
The Psychology Experiment Building Language 'PEBL' Test
Description
The PEBL is an electronic neuropsychological battery utilised to monitor adaptations in participants' neuropsychological functioning.
Time Frame
Change from Baseline neuropsychological functioning at up to 5 months
Title
Generalized Anxiety Disorder 7 (GAD-7) Scale
Description
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.
Time Frame
Change from Baseline anxiety levels at up to 5 months
Title
Patient Health Questionnaire 9 (PHQ-9) Scale
Description
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.
Time Frame
Change from Baseline depression levels at up to 5 months
Title
Weekly Problems Rating Scale
Description
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.
Time Frame
Change from Baseline emotional and behavioural functioning at up to 5 months
Title
Rosenberg Self-Esteem Scale 'RSES'
Description
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.
Time Frame
Change from Baseline levels of self-worth at up to 5 months
Title
The Valued Living Questionnaire 'VLQ'
Description
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).
Time Frame
Change from Baseline quality of life issues at up to 5 months
Secondary Outcome Measure Information:
Title
Helpful Aspects of Therapy Interview
Description
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.
Time Frame
One-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Dubrow-Marshall
Organizational Affiliation
University of Salford
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clare S Allely
Organizational Affiliation
University of Salford
Official's Role
Study Chair
Facility Information:
Facility Name
Greater Manchester Mental Health NHS Trust (GMMH - IAPT Headquarters, Chorlton House)
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M219UN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study forms part of a doctorate qualification, as per University policy, all data will comply will GDPR (2018) and may be stored on a University encrypted drive for up to three years. The thesis itself may contain non-identifiable patient data such as interview extracts however this will be limited to consent.
Citations:
PubMed Identifier
36194890
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.
Results Reference
derived

Learn more about this trial

Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors

We'll reach out to this number within 24 hrs