The aim of the study is to test whether EMDR is effective to use as an intervention in order to reduce the severity and the burden of tinnitus and to determine whether the alleged effect of treatment is stable.
ID
Source
Brief title
Condition
- Other condition
- Hearing disorders
- Somatic symptom and related disorders
Synonym
Health condition
psychische stoornissen: PTSS
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is change in the level of symptoms as measured on
the Tinnitus Functional Index (TFI). This questionnaire measures the impact of
tinnitus symptoms and groups the complaints in eight domains: nuisance, sense
of control, cognitive interference, sleeping problems, hearing problems,
relaxation, quality of life, emotional state of mind. The TFI is a reliable and
valid survey instrument that is also designed to measure treatment effect in
addition to the impact of tinnitus symptoms (Meikle et al. 2012, Henry et al.
2014).
Secondary outcome
Secondary outcome measures are:
- The general level of mental and physical functioning, as measured by the
SCL-90 (Symptom Check List-90)
- Levels of trauma-related symptoms, as measured by the ZIL (Self Assessment
Questionnaire)
- The severity of tinnitus symptoms as measured by the MINITQ-12
It will also be explored if patients meet the criteria for undifferentiated
somatoform disorder and post-traumatic stress disorder (PTSD).
Background summary
Tinnitus, also known as ringing in the ear, is a common complaint in the
western world. 10-30% of the population is affected, 1-5% is severely affected.
The complaints of patients with tinnitus interfere significantly with daily
life: insomnia, concentration difficulties, absenteeism, anxiety, depression
and suicidality are common. The average social "costs of illness" is
significant: in 2012 it was ยค 6.7 billion (Novak-Maes, 2012). The risk of
tinnitus increases with increasing age and is closely associated with hearing
problems or hearing loss. Although much research is done, there is no
evidence-based treatment that will reduce the tinnitus symptoms and is easily
accessible for every patient. According to the most recent scientific insights,
the cause of tinnitus is attributed to neural plasticity. Through reduced input
in the auditore areas neural plasticity in the brain is formed in a
compensation reaction and can overshoot in overactivity. This process is
similar to phantom limb pain: Tinnitus can also be called phantom sound in that
sense. Such overactivity in the brain is also seen in PTSD patients.
In previous research (Roos & Rood, 2010) demonstrated that EMDR (eye movement
desensitization and reprocessing) can greatly reduce the severity of phantom
pain and even make it disappear. EMDR is an evidence-based psychological
treatment which is frequently used and with good effect in PTSD (Post
Traumatic Stress Disorder). Considering the analogy with phantom pain and PTSD
it is believed that treatment with EMDR could diminish the impact of tinnitus
symptoms on the life of tinnitus patients.
Study objective
The aim of the study is to test whether EMDR is effective to use as an
intervention in order to reduce the severity and the burden of tinnitus and to
determine whether the alleged effect of treatment is stable.
Study design
The research is conducted with a within group design. For the study 32
participants are required, based on a medium effect size. To compensate for
eventual loss 40 participants are recruited from four hospitals: Riverland
Hospital, Medical Centre Alkmaar, LUMC and St.Antonius Nieuwegein.
Patients will be asked by the otolaryngologist where they are in treatment to
fill out a symptom questionnaire at the end of the consultation (cf regular
care). If they score above a cut-off point on a screening questionnaire (TFI
>54), they will recieve an extensive information package about the study. After
a week the patient will be contacted by telephone by a research assistant. In
the interview possible questions can be answered, after which the patient can
give his informed consent.
The first step will be to conduct research questionnaires (T1). After this, the
patient is placed in a waiting condition. After three months,again
questionnaires will be conducted (T2). Then, after the intake by the EMDR
therapist, the EMDR treatment starts. After 3 treatments, followed by a
questionnaire (T3), the treatment will be continued. After 6 sessions in total,
the treatment is completed and the questionnaires are taken again (T4). The
follow-up period covers three months. Thereafter, the patient is called for
survey-taking (T5) and a short final evaluation interview. This will finisch
the study.
Intervention
Participants are treated with EMDR (Eye movement desensitization and
reprocessing), an evidence-based and frequently used psychological treatment
for PTSD and its affiliated symptoms.
Participants will recieve treatment by a competent therapist (minimum level II
EMDR) in 6 sessions.
Study burden and risks
There are no security risks associated with the treatments. The tax in respect
of time exists of 5x half an hour to fill out questionnaires, an EMDR-oriented
intake of 90 minutes, 6 EMDR treatment sessions of 90 minutes. Total 13.5
hours, during 9 months, including 6 months waiting list and follow-up
condition. The intervention itself lasts approx. 3 months.
EMDR is a psychological intervention which is frequently and successfully
applied in PTSD but also in several other areas. EMDR is recognized and
reimbursed by insurers. After an EMDR session participants may experience some
disbalance by the emergence of memories. This part of the psychological process
and is a good sign. This usually lasts no longer than three days.
By participating in the study, the participants have a chance to reduce
individual tinnitus complaints. Indirectly, there is a benefit to society and
for future tinnitus participants and by participating they contribute to the
development of an effective treatment for tinnitus.
President Kennedylaan 1
Tiel 4002 WP
NL
President Kennedylaan 1
Tiel 4002 WP
NL
Listed location countries
Age
Inclusion criteria
age between 18-65 yrs.
subjective tinnitus
tinnitus exists longer than 6 months (chronic condition)
severity of tinnitus (TFI > 54)
Exclusion criteria
younger than 18 yrs, older than 65 yrs
slight impact of tinnitus on patient's life (TFI <54)
tinnitus exists shorter than 6 months
communication problems (severe hearingproblems, severe sightproblems, severe problems in communicating in Dutch, s.a. reading/talking/understanding)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL54362.100.15 |
OMON | NL-OMON22633 |