Immediate Effects of DLPFC tDCS on Attention Bias

Not Applicable

Withdrawn

• Conditions: Depression
• Interventions: Device: Transcranial direct current stimulation (tDCS)

• Registration Number: NCT05263440
• Lead Sponsor: Johns Hopkins University

Brief Summary

This research is being done to test if the investigators can modify or reduce negative attention bias in depression following a single session of transcranial direct current stimulation (tDCS) over the left anodal dorsolateral prefrontal cortex (DLPFC) in patients with mild to severe depression. The study will consist of a single-session tDCS session administered onsite at the Johns Hopkins University (JHU). After the consent process, participants will complete the study (approximately one hour in duration) with the guidance of a research associate.

Detailed Description

This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to severe depression (based on BDI-II score range 14-19 for mild and 29-63 for severe) to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Subjects may or may not be receiving treatment for mild-severe depression.

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2023-03-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Aged 18-45
• Female
• Mild to severe depression (determined by BDI-II scores of 14-19 and 29-63, respectively)
• If taking antidepressants, medication must be stable ≥ 30 days prior to screening

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Exclusion Criteria

• Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score <85 (to ensure understanding of test procedures)
• Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff
• Primary psychiatric disorder other than depression (based on MINI)
• Primary neurologic condition that would prevent ability to participate (as determined by study clinician).
• History of head trauma in the last year
• Medical device implants in the head or neck
• History or current uncontrolled seizure disorder
• Current substance abuse disorder
• Pregnant or lactating women
• Skin disorder/sensitive skin near stimulation locations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Female participants with Depression	Transcranial direct current stimulation (tDCS)	Female participants with mild to severe depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.

Primary Outcome Measures

Name	Time	Method
Level of Anxiety before Transcranial direct current stimulation (tDCS)	Study tDCS Administration Visit (Day1)	Measured by the Beck Anxiety Inventory (BAI) which is a brief, criteria-referenced assessment for measuring anxiety severity and level. Participants respond to 21 items rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. BAI has been found to discriminate well between anxious and non-anxious diagnostic groups in a variety of clinical populations.
Change in the negative mood after Transcranial direct current stimulation (tDCS)	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)	Will be assessed by using the Analog Mood Scale (AMS). This is a brief measure of positive and negative mood consisting of three questions (i.e., "How anxious are you?", "How sad are you?", and "How happy are you?"). Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much).
Change in attention bias using the Dot Probe task	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)	The dot-probe task will be used to assess depression-related attention bias before and after tDCS administration.To complete the Dot-Probe task, participants will be shown two emotional images (e.g., sad and neutral pair or happy and neutral pair) simultaneously followed by a target in the location of one of the emotional images. Response latencies to targets replacing either the negative/positive or neutral images will be measured before and after training which will be the primary study outcome.
Level of Depression before Transcranial direct current stimulation (tDCS)	Study tDCS Administration Visit (Day1)	Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression.
Intensity level of Depressive Symptoms using SMDDS	Study tDCS Administration Visit (Day1)	The Symptoms of Major Depressive Disorder Scale (SMDDS) is a brief self reported measure for adults with MDD and measures specific symptom dimensions. The qualitative measure has good psychometric properties including high reliability and validity.
Change in the negative affect after Transcranial direct current stimulation (tDCS)	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)	The Positive and Negative Affect Schedule (PANAS-SF) will be administered before and after the Transcranial direct current stimulation (tDCS) session. This is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect.
Intensity level of Depressive Symptoms	Study tDCS Administration Visit (Day1)	Measured by the Hamilton Depression Rating Scale (HAM-D) which is a 17-item measure that was designed to assess frequency and intensity of depressive symptoms in patients with Major Depressive Disorder (MDD). This measure contains somatic and suicidal ideation items and has demonstrated reliability, validity, and efficiency in adult populations
Change in attention bias using the Visual Search task	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)	The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias alongside the Dot Probe task. For this task, mean response time (the time between display onset and button press) to the target stimulus for each stimulus type is measured as the main outcome variable.