Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity in Indonesian PTSD patients: a study protocol for a randomized controlled trial

• Register: ISRCTN
• Last refreshed on: 30 May 2022
• Main ID: ISRCTN55239132
• Date of registration: 19/12/2017
• Prospective Registration: Yes
• Primary sponsor: BUDI LN_LPDP (Indonesian Scholarship)
• Public title: Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity in Indonesian PTSD patients: a study protocol for a randomized controlled trial
• Scientific title: Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity: a study protocol for a randomized controlled trial
• Date of first enrolment: 01/04/2018
• Target sample size: 70
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN55239132
• Study type: Interventional
• Study design: Interventional randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Indonesia

Contacts

• Name: Eka Susanty

Key inclusion & exclusion criteria

Inclusion criteria:
Current inclusion criteria as of 14/01/2020:
1. Diagnostic and Statistical Manual of Mental Disorder, fifth edition (DSM-5) diagnosis of PTSD as diagnosed with the Structured Clinical Interview for DSM-5 disorders (SCID-5)
2. Age of 18 years or older

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Previous inclusion criteria:
1. Individuals who were either diagnosed posttraumatic stress disorder (PTSD) by a professional, i.e., by a clinical psychologist and meet DSM-V-TR, the diagnostic rule which requires at least one criteria of A, B, and C and at least two criteria of D and E and with cut off 33 of PCL-5 score
2. Suffering from posttraumatic stress symptoms on a subclinical level with one symptom in each criterion of PTSD symptoms and with cut off 20 of PCL-5 score
3. Minimal age of 18 years

Exclusion criteria:
Current inclusion criteria as of 14/01/2020:
1. Current or previous psychotic disorder
2. Current substance use disorder
3. Acute suicidality
4. Current organic disorder i.e. epileptic, brain damage

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Previous exclusion criteria:
1. Individuals with current organic disorders, psychotic disorders, substance abuse, or suicidal ideation will be excluded
2. Individuals that are currently taking any medication for psychological or psychiatric disorders are excluded


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Posttraumatic stress disorder
Mental and Behavioural Disorders
Posttraumatic stress disorder

Intervention(s)

Current interventions as of 14/01/2020:
In this study, the design is a randomised controlled trial (RCT) by blocked randomisation. If a participant meets inclusion criteria a baseline assessment, pre-intervention (T0) is conducted before he or she are randomised and introduced to the corresponding study arm (study arm 1 and 2). Participants are randomised to one of two groups. This study compares the EMDR condition with an exposure condition, which consists of a similar therapy protocol but excluding the eye movements.

The time span between T0 and the first intervention session are kept to about one to two weeks. After four sessions in each condition, stress reactivity is measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, post-intervention assessment are conducted (T2), including stress-reactivity, brain activity and PTSD symptoms. Finally, at six months (T3) a follow-up assessment is conducted to be able to evaluate longer-term effectivity. The follow-up assessment are performed in two steps. First, participants are contacted personally and motivated to complete the follow-up instrument. In case participants refuse the telephone interview, they are offered an assessment of the primary outcome only. If participants still refuse, they are asked to provide reasons for their refusal, which is documented.

The endpoints of the study change in neurobiological parameters; Heart rate (HR), Heart Rate Variability (HRV) and Pre-ejection (PEP) responses to trauma-related stimuli. Secondary outcomes of the study are change of cortisol level and reduction in PTSD symptoms based on Clinician-Administered PTSD Scale (CAPS-5), and PCL-5 (PTSD Ch

Primary Outcome(s)

Current primary outcome measure as of 14/01/2020:
Heart Rate Variability (HRV) measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3)
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Previous primary outcome measure:
1. Heart Rate (HR)/Heart Rate Variability (HRV) is measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3)
2. Pre-ejection period (PEP) is measured using the VU AMS device at baseline (T1), during intervention (T1), post-treatment (T2) and 6 months follow up (T3)

Secondary Outcome(s)

Current secondary outcome measures as of 14/01/2020:
At baseline (T0), during intervention (T1), post-treatment (T2) and 6 months follow up (T3):
1. Heart Rate (HR) measured using the VU AMS device
2. Pre-ejection period (PEP) measured using the VU AMS device
3. Diagnosis of DSM-5 Axis I disorder using the SCID-5 questionnaire
4. PTSD symptoms using the PCL-5
5. Experiences of traumatic events using Live Events Checklist (LEC)
6. Anxiety and depression symptoms using The Hopkins Symptoms Checklist-25 (HSCL-25)
7. Perceived feelings and thought of stress during the last month using The Perceived Stress Scale (PSS)
8. Quality of life using the Indonesian version of the World Health Organization Quality of Life (WHOQOL-BREF)
9. Neurocognitive Functioning using the Digit Span subtest of the Indonesian WAIS-IV
10. Encoding, short-term retrieval, and recognition of verbal information using The California Verbal Learning Test (CVLT)
11. Information processing speed, shift of attention, planning, and cognitive ?exibility using The Trail Making Test (TMT)

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Previous secondary outcome measures:
1. Cortisol level is measured using salivary samples using The Salimetrics Cortisol Enzyme Immunoassay Kit at baseline (T0), post-treatment (T2) and six months follow up (T3)
2. PTSD symptom score is measured using CAPS (Clinican Administered PTSD Scale) at baseline (T0), post-treatment (T2) and 6 months follow up (T3)
3. PTSD symptom score is measured using PTSD Checklist for DSM-5 at baseline (T0), post-treatment (T2) and six months follow up (T3)

Secondary ID(s)

ID_01

Source(s) of Monetary Support

Indonesia Endowment Fund for Education (LPDP)

Ethics review

Status:
Approval date:
Contact:

The Research Ethics Committee Universitas Padjadjaran Bandung, 26/06/2018, 655/UN6.KEP/EC/2018

Results

• Date Completed: 30/12/2020