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

NCT03966963 | Completed DMC

• 1 other identifier: 786
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Psychological

Keywords

Eye Movement Desensitization Reprocessing; EMDR; childhood sexual abuse; posttraumatic stress disorder; PTSD; adults

Outcome Measures

Primary Outcomes (7)

• 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.

  Change from Baseline PTSD symptomology at up to 5 months

• The Psychology Experiment Building Language 'PEBL' Test

  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

  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

  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

• 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.

  Change from Baseline emotional and behavioural functioning at up to 5 months

• 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.

  Change from Baseline levels of self-worth at up to 5 months

• 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).

  Change from Baseline quality of life issues at up to 5 months

Secondary Outcomes (1)

• Helpful Aspects of Therapy Interview

  One-month follow up

Study Arms (1)

Eye Movement Desensitization Reprocessing (EMDR)

EXPERIMENTAL

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).

Behavioral: Eye Movement Desensitization Reprocessing (EMDR)

Interventions

Eye Movement Desensitization Reprocessing (EMDR) BEHAVIORAL

Trauma-Focused Therapy

Eye Movement Desensitization Reprocessing (EMDR)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

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

Manchester, Greater Manchester, M219UN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36194890 DERIVED

MeSH Terms

Conditions

Psychological Trauma; Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Dubrow-Marshall

  University of Salford

  STUDY CHAIR

• Clare S Allely

  University of Salford

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Research Student

Model Details: Mixed methods study

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 29, 2019
• Study Start: September 17, 2019
• Primary Completion: September 30, 2020
• Study Completion: November 3, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)