Study (i) - NET: Observational treatment study Primary Objective:1A. To establish if emotion regulation and perceived daily stress have changed after NET treatment in responders (i.e. significant reduction in PTSD symptoms) and in non-responders (i.…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study (i): Main study parameters are mood, PTSD symptoms, perceived daily
stress and emotion regulation before, after and during treatment.
Study (ii): Main study parameters are emotion regulation, bodily awareness,
self esteem and self-efficacy before, during and after treatment.
Secondary outcome
Post-traumatic stress and personal recovery.
Background summary
Displaced Victims of Interpersonal Violence (DVIVs) are often challenged by
past traumatic experiences and invalidating daily stressors. These daily
stressors are risk factors for developing and maintaining psychopathology,
mainly a post traumatic stress disorder (PTSD). Furthermore, the combination of
past traumatic experiences and social daily stressors increases the risk of
(sexual) revictimization. Meanwhile psychological treatments, targeting PTSD,
are less effective in DVIVs compared to other populations.
The MORE study is designed to explore if perceived daily stress and emotion
regulation are altered during trauma-focussed psychotherapy (i.e. Narrative
Exposure Therapy; NET), and how they interact with changes in psychopathology
during NET (study i NET). Expected is that non-response in PTSD symptoms goes
along with non-response in perceived daily stress and emotion regulation. For
responders on PTSD symptoms we expect significant response on emotion
regulation and perceived daily stress. Expected is that PTSD response precedes
responses in perceived daily stress and emotion regulation for treatment
responders. Furthermore a treatment module specifically tailored to address
prominent issues for the population (i.e. increased risk of (sexual)
revictimisation by PreVic (study ii) will be evaluated. Foreseen is that the
treatment will have a beneficial effect on emotion regulation, bodily
awareness, self esteem en self-efficacy (PreVic).
Study objective
Study (i) - NET: Observational treatment study
Primary Objective:
1A. To establish if emotion regulation and perceived daily stress have changed
after NET treatment in responders (i.e. significant reduction in PTSD symptoms)
and in non-responders (i.e. no significant reduction in PTSD symptoms).
1B. To establish if changes in perceived daily stress, emotion regulation and
psychopathology during the course of NET are different in responders than in
non-responders.
Secondary Objectives
2. To establish if victims of childhood trauma are underrepresented in
treatment responders (i.e. significant reductions in PTSD symptoms).
3. To establish if personal recovery has changed after NET.
4. To establish if changes in emotion regulation, perceived daily stress and
personal recovery after NET persist at 6 weeks follow-up.
Study (ii) Potential effects of PreVic
Primary Objective:
1. To establish if emotion regulation, bodily awareness, self esteem and
self-efficacy change during PreVic.
Secondary Objective:
2. To establish if PreVic can be considered a feasible and acceptable therapy
by both patients and therapists.
Study design
Study (i):
The NET study will entail an observational treatment design in which repeated
weekly measurement will be added to Narrative Exposure Therapy.
Study (ii):
The PreVic study will follow a case series design in which repeated
assessments will be conducted before, during and after treatment.
Study burden and risks
The MORE study containts 2 sub-studies:
Study NET (i): Participants will follow NET, which is an evidence based therapy
for DVIVs. A couple adaptations to regular treatment procedure are made.
Questionnaires will be administered before (T0), after (T1) treatment and at 6
weeks follow up (T2), partly overlapping the routine outcome monitoring. Also
brief assessments will take place before every therapy session. All
questionnaires together this will take a maximum of 325 minutes without
interpreter and a maximum of 395 minutes with interpreter. Furthermore
participants are excluded from other therapies during NET, and until the
follow-up measurement (T2) after NET. Exceptions are made for pharmacotherapy
and crisis consultation during treatment, during waitlist and between T1 and T2
psychoeducation is additionally allowed. It is unlikely that participation in
this study will be counterproductive and we consider the burden of the study
reasonable.
Study PreVic (ii): Participants will follow treatment as indicated. Additional
questionnaires will be administered weekly during treatment, as well as before
treatment (T0), after treatment (T1) and at 4 weeks follow-up (T2). For the
PreVic study assessments will take maximum 250 minutes without and maximum 325
minutes with interpreter. During inclusion period participants are excluded
from other treatments, except pharmacotherapy and crisis consultation during
treatment and between T1 and T2 psychoeducation is additionally allowed. It is
unlikely that participation in this study will be counterproductive and we
consider the burden of the study reasonable.
Routine Outcome Monitoring (ROM): For all studies a total of 45 minutes
(without interpreter)/60 minutes (with interpreter) questionnaire
administration time coincides the routine outcome measurement (ROM). ROM is a
standard treatment procedure that all patients undergo, independent of research
participation.
Nienoord 13
Diemen 1112XE
NL
Nienoord 13
Diemen 1112XE
NL
Listed location countries
Age
Inclusion criteria
For the NET study
• Aged 18 years or older
• Displaced Victims of Interpersonal Violence (DVIVs)
• PTSD as primary diagnosis established during a clinical interview
• Indicated for trauma focused treatment
• Informed consent
• Cognitively able to give consent to participate in the study
For the PreVic study:
• Aged 18 years or older
• Displaced victims of interpersonal violence (DVIVs) subcategory: victim of
sexual exploitation and/or sexual violence
• Treatment indication for PreVic
• Informed consent
• Cognitively able to give consent to participate in the study
Exclusion criteria
For all studies:
• Acute crisis or acute suicidality
• Substance abuse
• Acute psychosis
For the NET study:
• Recent (less than 6 months ago) completed trauma-focused treatment
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL61808.058.17 |