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New treatment for fear of the future in MS patients


- candidate number23673
- NTR NumberNTR5705
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2016
- Secondary IDsNL54423.028.15 
- Public TitleNew treatment for fear of the future in MS patients
- Scientific TitleEMDR treatment for anxiety in MS patients
- ACRONYM
- hypothesisThe objective of this study is to examine whether EMDR with flashforward targets can be effective in reducing anxiety related to the future in MS patients. Specifically, following hypotheses will be examined: EMDR with flashforward target significantly decreases anxiety, and decreases worrying as well as improving QoL more, compared to Supportive Listening.
Our hypothesis is that cognitive status (having cognitive disorders) does not influence the treatment effect of EMDR therapy. And that patients with higher Subjective Unit of Disturbance (SUD) scores and patients with more cognitive avoidance strategies benefit more from EMDR therapy
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS), Anxiety
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
ボ diagnosis Multiple Sclerosis
ボ Dutch speaking
ボ adult (18+)
ボ HADS-A score 8 or higher
ボ anxiety related to the future
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
ボ severe psychiatric comorbidity; i.e. dissociation, high suicide risk
ボ following other psychological treatment at the same time
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-feb-2017
- Target number of participants52
- Interventionsgroup A (treatment group): EMDR treatment with flash forward target
group B (control group): supportive listening
- Primary outcomePrimary parameter:
Anxiety scores on the hospital anxiety and depression scale (HADS-A).
The HADS questionnaire is specially designed to measure mood disturbance in people with physical illness (Zigmond and Snaith 1983).
- Secondary outcomeOther parameters:
- Penn State Worry Questionnaire (PSWQ) scores. The PSWQ is a diagnostic indicator of excessiveness and uncontrollability of worry in non-clinical populations and patient samples (van der Heiden, Muris et al. 2010). Although there is not a norm group specific for MS patients, the PSWQ is used to examine worry in MS (Thornton, Tedman et al. 2006).
ボ Scores on Quality of Life questionnaire: World Health Organisation Quality of Life (WHOQOL-bref). WHOQOL-bref is a solid, cross-cultural valid assessment of Quality of Life, reflected in four domains; physical, psychological, social and environment (Skevington et al., 2004). Although there is not a norm group specific for MS patients, the WHOQoL was been used to examine quality of life in MS (Phillips, Saldias et al. 2009, Wynia, Middel et al. 2009).
- TimepointsT0 (premeting, pre treatment)
T1 (nameting, post treatment)
T2 (follow-up 3 maanden)
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES O.C. Wallis
- CONTACT for SCIENTIFIC QUERIES O.C. Wallis
- Sponsor/Initiator Medical Center ETZ
- Funding
(Source(s) of Monetary or Material Support)
Medical Center ETZ
- Publications-
- Brief summaryRationale: Prevalence of anxiety in MS patients is high and anxiety itself can contribute to the overall decrease of Quality of Life (QoL). The anxiety of MS patients seems mostly specifically focused on the future related to their MS. Evidence of applicability of Eye Movement Desensitisation Reprocessing (EMDR) to desensitize a feared 蜘orst case scenario in the future (flash forward) is growing. EMDR is a cost-effective psychotherapy, especially due to the short duration of the treatment. However, research is needed to examine the flash forward EMDR procedure as treatment option for feared future events.

Objective: The objective of this study is to examine whether EMDR with flashforward targets can be effective in reducing anxiety related to the future in MS patients. Specifically, following hypotheses will be examined: EMDR with flashforward target significantly decreases anxiety, and decreases worrying as well as improving QoL more, compared to Supportive Listening.

Our hypothesis is that cognitive status (having cognitive disorders) does not influence the treatment effect of EMDR therapy. And that patients with higher Subjective Unit of Disturbance (SUD) scores and patients with more cognitive avoidance strategies benefit more from EMDR therapy.

Study design: Controlled intervention study, with randomised controlled design (RCT).

Study population: MS patients (all types of MS) treated in the MSpoli in Elisabeth Tweesteden Hospital (ETZ), suffering from anxiety (HADS-A >=8), male and female, age 18-80.

Intervention: Patients will randomly be assigned to getting EMDR treatment (EMDR ff) or supportive listening (SL).
- Main changes (audit trail)
- RECORD29-jan-2016 - 25-apr-2016


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