Primary Objective: The main aim of this study is to investigate if EMDR diminishes negative associations with fatigue in CFS-patients who follow CBT.Secondary Objective(s): Second, we will investigate if EMDR strengthens the belief of the patient…
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is negative associations with fatigue; these are
measured by daily scores on the adapted FQL-items. Participants will be asked
to click on a line of 0-10cm: *To what extent does the following adjective fit
your experienced fatigue? *.
Three adjectives will be chosen from the baseline assessment FQL-scores (T0) of
the individual participant.
Secondary outcome
Secundary study parameters are:
The cognition that one is recovered from CFS; this is measured daily by asking
the participant to click on a line ranging from of 0-10 cm (not credible at all
* completely credible): *How credible does it feel for you to say *I am
recovered from CFS*?
The experienced fatigue; this is measured daily by asking the participant to
click on a line ranging from of 0-10 cm (not fatigued at all * extremely
fatigued): *I feel today: *.
Background summary
CFS can be effectively treated with Cognitive Behaviour Therapy (CBT) but there
is room for improvement. Although the majority of the patients does benefit
from therapy and no longer meets the CDC-criteria for CFS, only a subgroup
fully recovers. Patients who do not fully recover, still consider themselves as
CFS-patients and still have a negative perception of fatigue. There are no
treatment options for patients who do not fully recover in CBT.
From both clinical practice and learning theory we hypothesize that negative
experiences with being severely fatigued can cause persistent negative
associations with fatigue, which might hinder full recovery. Eye Movement
Desensitization and Reprocessing (EMDR) is a safe and effective treatment for
negative memories. It is a recommended treatment for patients with Post
traumatic Stress Disorder (PTSD). EMDR is also used to treat negative memories
in patients with Chronic Pain. There is some evidence that this can decreases
pain and negative emotions about pain.
In this study we will experimentally test if EMDR can change negative
associations about fatigue. We will also test if EMDR diminishes the
experienced fatigue and stregthens the belief of the patient that he/she is
recovered from CFS
The goal is to determine if EMDR might be an additional treatment option for
CFS-patients who do not fully recover with CBT.
Hypotheses: Eye Movement Desensitization & Reprocessing (EMDR) changes
negative associations with fatigue. EMDR diminishes the experienced fatigue.
EMDR stregthens the belief of the patient that he/she is recovered from CFS.
Study objective
Primary Objective:
The main aim of this study is to investigate if EMDR diminishes negative
associations with fatigue in CFS-patients who follow CBT.
Secondary Objective(s):
Second, we will investigate if EMDR strengthens the belief of the patient that
he/she is recovered from CFS. In addition to this we will investigate if EMDR
decreases the experienced fatigue.
Study design
This is a simultaneously replicated, randomised single case experiment. The
purpose of this design is to test causal relationships between independent and
dependent variables.
Intervention
Participants will receive five one-hour sessions of EMDR, following an adapted
protocol. The sessions will be held within a two-week period.
Study burden and risks
There are no or only minimal risks involved in pausing the regular
CBT-treatment for 28-42 days because this treatment is in the latest stage and
in this group of patients a stagnation is noticed.
There are no or only minimal risks involved in following the EMDR-intervention.
The EMDR therapists are well trained and will be supervised by an EMDR-expert.
Possible minor side-effects will usually disappear within a few days.
It can be a burden for patients to fill in the daily questionnaires. These are
short (5-10 minutes) and time and way of administration is agreed upon between
patient and research team.
Participants have substantial potential benefits by following this extra
intervention because they are not completely recovered by following their
existing treatment.
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
Female, age of 18 * 65 years
Diagnosed with CFS; CDC-criteria met at start of CBT-treatment
Having received CBT for CFS; experienced success in increasing activities
Negative associations with fatigue (FQL at least one negative subscale >25%)
Not convinced that one is recovered from CFS: score * 6 on scale 0 * 10 *I am recovered from CFS*:
Exclusion criteria
Use of psychotropic drugs or daily use of painkillers;
Co-morbid psychiatric disorder (DSM-IV-R) at baseline assessment before start of CBT
Design
Recruitment
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 | NL52993.091.15 |