Internet-based Self-help for Tinnitus: The Role of Support

NCT ID: NCT01927991

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iCBT with therapeutic support

Participants work with the online self-help and receive additional therapeutic support on demand

Group Type EXPERIMENTAL

iCBT (internet-based, cognitive-behavioural therapy)

Intervention Type BEHAVIORAL

The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.

iCBT without therapeutic support

Participants work with the online self-help on their own and do not receive additional therapeutic support

Group Type ACTIVE_COMPARATOR

iCBT (internet-based, cognitive-behavioural therapy)

Intervention Type BEHAVIORAL

The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.

Interventions

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iCBT (internet-based, cognitive-behavioural therapy)

The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Cornelia Weise

Dr. rer. nat.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cornelia Weise, Dr.

Role: PRINCIPAL_INVESTIGATOR

Philipps-University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Locations

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Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

Marburg, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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Titus2

Identifier Type: -

Identifier Source: org_study_id

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