NCT01927991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

August 17, 2013

Last Update Submit

April 27, 2015

Conditions

Tinnitus

Keywords

tinnituscognitive behavioural therapyinternet treatment

Outcome Measures

Primary Outcomes (1)

  • Change in tinnitus distress

    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.

    1 year; pre, post, 6-mo-follow-up

Secondary Outcomes (3)

  • 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

Other Outcomes (1)

  • Screening of psychiatric symptoms

    Pre-Treatment

Study Arms (2)

iCBT with therapeutic support

EXPERIMENTAL

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

Behavioral: iCBT (internet-based, cognitive-behavioural therapy)

iCBT without therapeutic support

ACTIVE COMPARATOR

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

Behavioral: iCBT (internet-based, cognitive-behavioural therapy)

Interventions

iCBT (internet-based, cognitive-behavioural therapy)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 with therapeutic supportiCBT without therapeutic support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tinnitus duration of more than 6 months
  • severe or most severe tinnitus distress
  • age of at least 18 years
  • fluent in German

You may not qualify if:

  • psychosis, severe psychological disorder, risk for suicide
  • prior participation in associated study
  • medical disorder as reason for tinnitus, i.e. morbus ménière

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Marburg, Hesse, 35037, Germany

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cornelia Weise, Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. nat.

Study Record Dates

First Submitted

August 17, 2013

First Posted

August 23, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

DE(1)