The study aims to determine the effectiveness of the application of AET in decreasing self-reported deficits in autonomy-connectedness / self-reported symptoms of anxiety and depression in HI adults.
ID
Source
Brief title
Condition
- Other condition
- Hearing disorders
Synonym
Health condition
psycho-social disorder (autonomy deficit)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters /endpoints, outcomes in the psychosocial and mental
health domain are evaluated at the end of the experimental phase (T2) with
standardized questionnaires. A questionnaire of autonomy-connectedness
(Autonomy- Connectedness Scale-30, ACS-30) and questionnaires for anxiety
disorder (Symptom Checklist 90-R, SCL-90-R) and depression (Beck Depression
Inventory, BDI-II-NL).
Secondary outcome
In the secondary phase for clinical-therapeutical purposes the AET is provided
to the control group. T3 assessment with standardized questionnaires of
autonomy-connectedness and mental disorders is performed to verify effect of
therapy for the control group. In case of persisting autonomy-connectedness or
mental health disorders these assessments are necessary for referral for
further psychological care.
In the experimental group T3 the Autonomy-Connectedness scale-30 (ACS-30) is
used to assess the retention effect of AET in the experimental group.
Background summary
In scientific literature psychosocial problems and mental disorders such as
anxiety or depression are frequently reported in hearing-impaired (HI) adults
who use hearing aids/cochlear implants. A recent pilot in HI adults with CI in
which the Autonomy-Connectedness Scale (ACS-30) was used, has shown deficits in
autonomy-connectedness in 72% of the patients. Low autonomy-connectedness has
been acknowledged as a known risk factor for anxiety and depression. In HI
adults these problems are not only a consequence of the hearing loss itself,
but also of the communication problems and the social isolation that result
from it. In addition, within the HI group, low help-seeking behavior for this
type of problems is reported. Systematic evidence-based training for prevention
and treatment of mental disorders in adults with HI is currently not available.
Therefore, the present project focuses on the determination of the
effectiveness of Autonomy Enhancing Therapy (AET), a certified therapy in
Geestelijke Gezondheidszorg (GGZ- Mental Health Services) that is developed
supplementary to the ACS-30. AET has proven to be both effective and
cost-effective in normal-hearing adults with an autonomy deficit / anxiety
disorder, in a recent large-scale national RCT, when compared to cognitive
behavioral therapy.
Study objective
The study aims to determine the effectiveness of the application of AET in
decreasing self-reported deficits in autonomy-connectedness / self-reported
symptoms of anxiety and depression in HI adults.
Study design
This study is set up as a prospective longitudinal repeated measures randomized
control study, which measures the effectiveness of the application of AET in HI
adults compared to *Standard Audiological Support*.
Intervention
In the experimental phase of the study the experimental group receives Autonomy
Enhancing Therapy and the control group receives standard audiological support.
- The experimental treatment, Autonomy Enhancing Therapy, a certified GGZ
therapy which has proven cost-effective in hearing adults, will be carried out
according to the standardized procedure of 15 weeks of group therapy in which
eight persons receive two hours of weekly training. The intervention treatment
will be carried out by psychologists and social workers, who are certified AET
trainers and in addition, have ample experience in guidance of adults with
hearing loss.
- The control condition treatment consists of standard audiological support
during a timeframe that is similar to that of the AET. Standard audiological
support entails the general medical-technical aural rehabilitation services
provided at audiological centers and cochlear implant centers.
For clinical-therapeutical purposes the control group receives the AET in a
*Secondary phase* of the study.
Study burden and risks
No medical tests or medical treatments are involved in the study.
Participation benefits for the patient group are diagnosis and
treatment of psychosocial problems / mental health disorders that are
frequently present in the patient group but often undiagnosed.
The negative effect of the risk of an unexpected diagnosis of mental health
problems is minimized by the subsequent participation in the Autonomy Enhancing
Therapy study. These problems would otherwise remain untreated.
The burden consists of participation in the Autonomy Enhancing
(group)Therapy which entails 15 weeks with 2-hours group therapy sessions by
experienced therapists. Furthermore, linguistic assessment of 30 minutes
duration is carried out prior to one of these therapy visits.
In addition, at 3 moments (inclusion and pre and post treatment phase)
completion of three standardized mental health questionnaires has to be carried
out at home.
No risks are expected as a result of the treatment. Individual patients
are expected to benefit more from the AET on the psychosocial or mental health
domain, than from standard audiological support. The control group that
receives the proven effective AET after the experimental phase, in the
secondary phase, is not disadvantaged as compared to the experimental group
that receives AET in the experimental phase, because standard GGZ waiting list
times are not exceeded after diagnoses of mental health problems.
For both the experimental and the control group the mental health
status is expected to improve in this study and may prevent more severe
problems.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Hearing loss in the best ear >= 35 dB
and a clinically deviant score on at least one subscale ot the AGS-30 (below
average score)
Exclusion criteria
Receiving treatment for psychiatric problems or tinnitus.
Design
Recruitment
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 | NL80114.058.22 |