Trauma, PsychologicalEMDRNCT03966963
Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors
A study testing Eye Movement Desensitization Reprocessing (EMDR) in people with Trauma, Psychological, run by University of Salford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Psychological
- What is being tested?
- Eye Movement Desensitization Reprocessing (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2019to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Greater Manchester Mental Health NHS Trust (GMMH - IAPT Headquarters, Chorlton House)
Manchester, Greater Manchester, M219UN
About this study
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
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.
Read the 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?
- Conditions
- Trauma, Psychological
- Being tested
- Eye Movement Desensitization Reprocessing (EMDR)
- Keywords
- Eye Movement Desensitization Reprocessing; EMDR, childhood sexual abuse, posttraumatic stress disorder, PTSD, adults
- Medical subject headings
- Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization Reprocessing (EMDR)Behavioural
Trauma-Focused Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Eye Movement Desensitization Reprocessing (EMDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from Baseline quality of life issues at up to 5 months
Secondary outcomes (1)
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.
Measured: One-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start17 Sep 2019
- Primary completion30 Sep 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed methods study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halima Bibi, University of Salford
- Investigators
- Linda Dubrow-Marshall, Study chair, University of SalfordClare S Allely, Study chair, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966963
- Sponsor's protocol ID
- 786
- Acronym
- EMDR
- Status last verified
- Apr 2021
- First submitted
- 22 May 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36194890
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03966963
- Acronym / sponsor ID
- EMDR / 786
- Conditions
- Trauma, Psychological
- Keywords
- Eye Movement Desensitization Reprocessing; EMDR, childhood sexual abuse, posttraumatic stress disorder, PTSD, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods study
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization Reprocessing (EMDR) | Experimental | Behavioral: 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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Participants exhibiting;
- significant psychiatric comorbidity
- comorbid psychotic disorder
- bipolar disorder type 1
- alcohol or drug dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization Reprocessing (EMDR)Trauma-Focused Therapy | Behavioural | Eye Movement Desensitization Reprocessing (EMDR) |
Primary outcome
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.
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.
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.
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.
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.
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.
The Valued Living Questionnaire 'VLQ'
Time frame: Change from Baseline quality of life issues at up to 5 months
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).
1 secondary outcome
Helpful Aspects of Therapy Interview
Time frame: One-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 36194890Brown 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Dubrow-Marshall study chair
University of Salford
Clare S Allely study chair
University of Salford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization Reprocessing (EMDR) in people with Trauma, Psychological, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Events Scale-Revised 'IESR' (time frame: Change from Baseline PTSD symptomology at up to 5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.