Trial Outcomes & Findings for A Teleheath tDCS Approach to Decrease Cannabis Use (NCT NCT05005013)

Results Overview

K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Baseline, End of Intervention (Week 4)

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Active tDCS + Mindfulness Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Overall Study STARTED	31	16
Overall Study COMPLETED	22	13
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Active tDCS + Mindfulness Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Overall Study Withdrawal by Subject	5	1
Overall Study Lost to Follow-up	3	1
Overall Study Ineligibility	1	1

Baseline Characteristics

A Teleheath tDCS Approach to Decrease Cannabis Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Total n=35 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 11 • n=5 Participants	46.2 years STANDARD_DEVIATION 8.8 • n=7 Participants	45.7 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	13 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.

Outcome measures

Outcome measures
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Change in Kessler Psychological Distress Scale (K10) Score	6.4 score on a scale Standard Deviation 6.1	4.5 score on a scale Standard Deviation 4.2

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

The PA subscale includes 10 items describing positive mood states (e.g., "enthusiastic," "interested," "proud"), each rated on a Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.

Outcome measures

Outcome measures
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)	-1.3 score on a scale Standard Deviation 8.3	1.53 score on a scale Standard Deviation 8.6

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

The NA subscale consists of 10 items representing negative mood states (e.g., "upset," "nervous," "hostile"), each rated on a 5-point Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.

Outcome measures

Outcome measures
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)	-0.7 score on a scale Standard Deviation 5.2	3 score on a scale Standard Deviation 4.3

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.

Outcome measures

Outcome measures
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Change in Marijuana Craving Questionnaire (MCQ-17) Score	0.27 score on a scale Standard Deviation 9.5	0.8 score on a scale Standard Deviation 9.7

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

The version of CWS used in the study asks about symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that symptoms are having a larger negative impact on normal daily activities.

Outcome measures

Outcome measures
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Change in Cannabis Withdrawal Scale (CWS) Score	27.1 score on a scale Standard Deviation 29.4	7 score on a scale Standard Deviation 17.7

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

Self-reported measure.

Outcome measures

Outcome measures
Measure	Active tDCS + Mindfulness n=22 Participants Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	Sham tDCS + Mindfulness n=13 Participants Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.
Change in Number of Weekly Sessions of Cannabis Use	1.36 Sessions per week Standard Deviation 2.7	0.54 Sessions per week Standard Deviation 1.9

PRIMARY outcome

Timeframe: Baseline, End of Intervention (Week 4)

Self-reported measure.