TinnitusNCT03068871
A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
A study testing ACT and CET in people with Tinnitus, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
participants will be randomized into one of three groups: 3-session CET intervention, 3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2 hours and 10 participants will be assigned to each group. There will be two cohorts, with 30 participants in each cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- ACT and CET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Feb 2017to 23 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tinnitus lasting more than 3 months
- Hebrew speaking
- Use hearing aids if needed
- Signed informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
participants will be randomized into one of three groups: 3-session CET intervention, 3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2 hours and 10 participants will be assigned to each group. There will be two cohorts, with 30 participants in each cohort. The Waiting List group will receive the CET intervention after the groups have completed theirs.
- Conditions
- Tinnitus
- Being tested
- ACT, CET
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTOther
Psycho-educational group
CETOther
Psycho-educational group
| Study group | Role | What they receive |
|---|---|---|
| CET | Experimental | CET - Coping Effectiveness Training group. Receives: Other: CET |
| ACT | Experimental | ACT - Acceptance and Commitment Therapy group Receives: Other: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPE
Coping scale questionnaire
Measured: Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start28 Feb 2017
- Primary completion23 Jul 2017
- Study completion23 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068871
- Sponsor's protocol ID
- 0841-16-TLV
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2017
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients
- ClinicalTrials.gov ID
- NCT03068871
- Acronym / sponsor ID
- 0841-16-TLV
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 23 Jul 2017 (actual)
- Study completion
- 23 Jul 2017 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
participants will be randomized into one of three groups: 3-session CET intervention, 3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2 hours and 10 participants will be assigned to each group. There will be two cohorts, with 30 participants in each cohort. The Waiting List group will receive the CET intervention after the groups have completed theirs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CET | Experimental | Other: CETCET - Coping Effectiveness Training group. |
| ACT | Experimental | Other: ACTACT - Acceptance and Commitment Therapy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Tinnitus lasting more than 3 months
- Hebrew speaking
- Use hearing aids if needed
- Signed informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTPsycho-educational group | Other | ACT |
| CETPsycho-educational group | Other | CET |
Primary outcome
COPE
Time frame: Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)
Coping scale questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT and CET in people with Tinnitus, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPE (time frame: Before the intervention (T1) and at the end of intervention (T2-4 weeks after T1), 1 month after end of intervention (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.