Gaze Contingent Attentional Reinforcement in Major Depressive Disorder
ConditionMajor Depressive Disorder (MDD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTel Aviv University
About this trial
The main objective of this randomized controlled trial is to evaluate whether a gaze-contingent feedback task using negative reinforcement can serve as an effective attention-modification procedure and contribute to the treatment of Major Depressive Disorder (MDD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of MDD
MADRS>=7
Normal or corrected-t-normal vision
Disqualifiers
Present or past psychosis, manic or hypomanic episode, PTSD
High suicidal ideation or behavior
Severe alcohol or cannabis use disorder, and/or any severity of other substance use disorder (exepct nicotine use)
Pharmacological treatment if not stabilized for at least three months or concurrent psychotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
Aversive white noise
BehavioralParticipants will receveve gaze-contingent negative-reinforcement feedback according to their viewing patterns, such that when gazing at the target stimuli (i.e., happy faces) the noise will stop.
Music reward
BehavioralParticipants will receive gaze-contingent music-reward according to their viewing patterns, such that when gazing at the target stimuli (i.e., happy faces) the music will play.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Gaze contingent negative reinforcementActive comparator 1 intervention
Group B: Gaze contingent positive reinforcementPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
MADRS- diagnostic interview scores
Change from baseline- the Montgomery Asberg Depression Rating scale is a clinician-administered scale that includes 10 items that measure the severity of depressive symptoms. Each of the 10 items is scored on a 7-point scale (0-6). The total score, ranging from 0 to 60 is used to assess severity.
Time frame
Post-treatment (1 week after treatment completion) and 3-month follow upSecondary outcomes
1
PHQ-9 - self report measure
Change from baseline- the Patient Health Questionnaire-9 is a nine-question self-report questionnaire to assess the severity of depression based on symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The overal score ranges from 0-27, indicating depression severity.
Time frame
Post-treatment (1 week after treatment completion) and 3-month follow upOther outcomes
1
Attention Allocation
Changes from baseline- attention allocation towards the target stimuli (happy faces) compared to the non-target stimuli (sad faces).
Time frame
Post-treatment (1 week after treatment completion) and 3-month follow up2
M.I.N.I diagnosis- diagnostic interview
Changes in the Mini-International Neuropsychiatric Interview diagnosis. The M.I.N.I. is a structured diagnostic interview for DSM-5 and ICD-11 psychiatric disorders.
Time frame
Post-treatment (1 week after treatment completion) and 3-month follow upSponsors and contacts
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Source ClinicalTrials.gov
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