Depression, UnipolarNCT02945735
Gaze Contingent Feedback in Major Depressive Disorder (MDD)
A study testing Attention Modification in people with Depression, Unipolar and Depressive Disorder, run by Tel Aviv University at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Unipolar, Depressive Disorder, Depressive Disorder, Major
- What is being tested?
- Attention Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Nov 2016to 7 Jan 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed consent form
- Men and women between the ages of 18 and 65.
- Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV
- MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
- Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.
Who cannot join
- Psychotic episode in the past or the present time.
- Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
- Another psychotherapeutic treatment during the study.
- Usage of neuroleptic medication.
- Change in medication status during the study.
- Substantial usage of drugs or alcohol in the present time.
- Poor judgment capacity (i.e., children under 18 and special populations).
- High Risk of Suicide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaze Contingent Feedback in Major Depressive Disorder
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)
Read the detailed description
The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.
- Being tested
- Attention Modification
- Keywords
- depression, cognitive bias modification, MDD, major depressive disorder, attention bias modification treatment
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention ModificationBehavioural
Feedback according to participants' viewing patterns, in order to modify their attention.
| Study group | Role | What they receive |
|---|---|---|
| gaze-contingent | Experimental | Attention modification: participants will receive gaze-contingent feedback according to their viewing patterns Receives: Behavioral: Attention Modification |
| non-gaze contingent | Placebo comparator | Participants will receive non-gaze-continent feedback unrelated to their viewing patterns Receives: Behavioral: Attention Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
The SIGMA is a ten-item diagnostic structured interview which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on scale ranging from 0 to 6 with a possible total score of 60, with regard to the passing week.
Measured: post treatment (1 week after treatment completion) and 3-month follow up
Secondary outcomes (1)
Change from baseline - BDI-II - Beck Depression Inventory
The BDI -II is a 21-question multiple-choice self-report inventory. Each item is rated on scale ranging from 0 to 3, Higher total scores indicate more severe depressive symptoms.
Measured: post treatment (1 week after treatment completion) and 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start6 Nov 2016
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, Phd, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945735
- Sponsor's protocol ID
- TAUDEPI
- Status last verified
- Dec 2019
- First submitted
- 25 Oct 2016
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze Contingent Feedback in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02945735
- Acronym / sponsor ID
- TAUDEPI
- Keywords
- depression, cognitive bias modification, MDD, major depressive disorder, attention bias modification treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 6 Nov 2016 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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.
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)
Detailed description
The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gaze-contingent | Experimental | Behavioral: Attention ModificationAttention modification: participants will receive gaze-contingent feedback according to their viewing patterns |
| non-gaze contingent | Placebo comparator | Behavioral: Attention ModificationParticipants will receive non-gaze-continent feedback unrelated to their viewing patterns |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A signed consent form
- Men and women between the ages of 18 and 65.
- Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV
- MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
- Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.
Key exclusion criteria (8 listed)
- Psychotic episode in the past or the present time.
- Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
- Another psychotherapeutic treatment during the study.
- Usage of neuroleptic medication.
- Change in medication status during the study.
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 |
|---|---|---|
| Attention ModificationFeedback according to participants' viewing patterns, in order to modify their attention. | Behavioural | gaze-contingent, non-gaze contingent |
Primary outcome
Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)
Time frame: post treatment (1 week after treatment completion) and 3-month follow up
The SIGMA is a ten-item diagnostic structured interview which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on scale ranging from 0 to 6 with a possible total score of 60, with regard to the passing week.
1 secondary outcome
Change from baseline - BDI-II - Beck Depression Inventory
Time frame: post treatment (1 week after treatment completion) and 3-month follow up
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 18 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Yair Bar-Haim, Phd principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Modification in people with Depression, Unipolar and Depressive Disorder, run by Tel Aviv University 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 5 inclusion and 8 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 18 Dec 2019. 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. Some participants in this study may receive a placebo. 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?
Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA) (time frame: post treatment (1 week after treatment completion) and 3-month follow up). 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 18 Dec 2019.