Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-based Cognitive-behavioral Psychotherapy for Chronic Tinnitus-sufferers
Brief Summary: The study aims to develop and to evaluate a psychophysiological intervention for distressing chronic tinnitus. Therefore 100 people suffering from chronic tinnitus are randomly assigned to either an intervention-group, receiving 12 sessions of a psychophysiological oriented intervention, or to a waiting-list-group, who are waiting for a comparable time period. Afterwards, patients of the waiting-list-group also receive intervention. The effects of the intervention on severity, distress and perceived loudness of the tinnitus as well as on other psychological variables like depression or self-efficacy are evaluated through comparing the results of the intervention group with those of the waiting-list-group.

Additionally the psychophysiological reactivity under different stress-conditions is measured before and after intervention or waiting. Therefore the activity of the muscles of head and shoulders (EMG) as well as the skin temperature and skin conductance are measured. It is hypothesized that patients with stronger psychophysiological reactivity benefit more from an psychophysiological intervention.


Options:
A: Inclusion Criteria

Participant's eligibility for the study is as follows:

1. Aged 18 years and over living in the UK
2. The ability to read and type in English
3. No barriers to using a computer (e.g. significant fine motor control or visual problems)
4. Internet and e-mail access, and the ability to use these
5. Commitment to completing the programme
6. Completion of the online screening and outcome questionnaires
7. Agreeing to participate in either group and be randomized to one of these groups
8. Understanding and working towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same
9. Be available for 12 months after starting the study to complete a 1 year follow-up questionnaire
10. Suffering with tinnitus for a minimum period of 3 months
11. Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above on the Tinnitus Functional Index)

Exclusion Criteria

1. Reporting any major medical or psychiatric conditions
2. Reporting pulsatile, objective or unilateral tinnitus, which have not been investigated medically
3. Tinnitus as a consequence of a medical disorder, still under investigation
4. Undergoing any tinnitus therapy concurrently to partaking in this study
B: Inclusion Criteria:

* Subjective tinnitus complaints
* Referred to Tinnitus centre Limburg

Exclusion Criteria:

* Not being able to write and read in Dutch
C: Inclusion Criteria:

* Tinnitus type: chronic, subjective, non - pulsatile tinnitus
* Duration of tinnitus = more than 3 months
* Minimum age of the patient is 18 years old - maximum age is 75 years old
* Tinnitus Functional Index (TFI) score ≥ 25 - \< 90
* Stable use of medication during therapy

Exclusion Criteria:

* HADS - score: anxiety and depression-subscores \> 15
* HQ - score \> 40
* Objective, pulsatile tinnitus
* Active middle ear pathology
* Neurological and psychiatry co-morbidity for which currently psychotherapy is ongoing
* Psychosis, schizophrenia, epilepsy
* Pregnancy
D: Inclusion Criteria:

* 100 subjects with distressing and chronic tinnitus (for at least 6 month)
* age: 16-75 years
* sufficient language skills

plus

* 50 healthy control-subjects
* without tinnitus or other hearing disease

Exclusion Criteria (for both):

* tinnitus as a result of medical disease (e.g.Meniere's disease)
* attendance in the previous study
* psychosis or dementia

Answer: D