Internet-based Self-help for Tinnitus: The Role of Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Change in tinnitus distress
Study Overview
Brief Summary
Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •tinnitus duration of more than 6 months
- •severe or most severe tinnitus distress
- •age of at least 18 years
- •fluent in German
Exclusion Criteria
- •psychosis, severe psychological disorder, risk for suicide
- •prior participation in associated study
- •medical disorder as reason for tinnitus, i.e. morbus ménière
Arms & Interventions
iCBT with therapeutic support
Participants work with the online self-help and receive additional therapeutic support on demand
Intervention: iCBT (internet-based, cognitive-behavioural therapy) (Behavioral)
iCBT without therapeutic support
Participants work with the online self-help on their own and do not receive additional therapeutic support
Intervention: iCBT (internet-based, cognitive-behavioural therapy) (Behavioral)
Outcomes
Primary Outcomes
Change in tinnitus distress
Time Frame: 1 year; pre, post, 6-mo-follow-up
Assessment of tinnitus distress with the Tinnitus Handicap Inventory (THI) and the Mini-Tinnitus Questionnaire (Mini-TQ) Newman, C. W., Jacobson, G. P., \& Spitzer, J. B. (1996). Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg, 122(2), 143-148. Hiller, W., \& Goebel, G. (2004). Rapid assessment of tinnitus-related psychological distress using the Mini-TQ. Int J Audiol, 43(10), 600-604.
Secondary Outcomes
- Change in depressive Symptoms(1 year; pre, post, 6mo-follow-up)
- Change in tinnitus-related thoughts(1 year; pre, post, 6mo-follow-up)
- Change of tinnitus acceptance(1 year; pre, post, 6mo-follow-up)
Investigators
Cornelia Weise
Dr. rer. nat.
Philipps University Marburg Medical Center