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The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS) treatment. No active brain stimulation is given.
The main questions this study aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label sham | Other | All study participants will receive sham TMS (no active stimulation will be provided). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation Sham | Device | All study participants will receive sham TMS (no active stimulation will be provided). |
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| Measure | Description | Time Frame |
|---|---|---|
| Accelerated sham TMS feasibility | Proportion of participants who complete the accelerated sham TMS protocol, defined as completion of all scheduled stimulation sessions. Feasibility will be assessed using session attendance logs and protocol completion records. | From enrollment to end of study at 5 weeks |
| Change in treatment expectancy and beliefs | Change in treatment expectancy and beliefs score from baseline to end of study at 5 weeks, as measured by the Credibility/Expectancy Questionnaire (CEQ). Outcomes will be quantified as the difference in total CEQ score between time points. CEQ scores range from 1 to 9 for treatment credibility and expectancy, with higher scores indicating greater perceived credibility/ expectancy. | From enrollment to end of study at 5 weeks |
| Change in reward sensitivity | Change in reward sensitivity will be assessed as the difference in scores from baseline to 5-week follow-up on validated self-report measures, including the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), the Snaith-Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS). SPSRQ scores range from 0-24 for each subscale, TEPS scores range from 18-108, and SHAPS scores range from 14-56, with higher scores indicating greater sensitivity to reward/punishment, pleasure capacity, and anhedonia, respectively. | From enrollment to end of study at 5 weeks |
| Change in craving and engagement | Changes in cravings and engagement with reinforcing stimuli will be assessed as the difference in scores from baseline to 5-week follow-up on various self-report measures and tasks. Craving will be assessed using a behavioral craving task, with outcomes quantified as change in task-derived craving ratings or performance metrics from baseline to follow-up. Substance use will additionally be assessed as change in drug use frequency and quantity over the study period. | From enrollment to end of study at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depressive symptoms | Change in depressive symptoms will be measured as the difference in total score from baseline to 5-week follow-up on the Montgomery-Asberg Depression Rating Scale (MADRS). MADRS scores range from 0-60, with higher scores indicating greater depressive symptom severity. | From enrollment to end of study at 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Recruiting | Sacramento | California | 95817 | United States |
De-identified individual participant data underlying the primary and secondary outcome measures will be shared in accordance with the Institutional Review Board, including demographic variables, symptom rating scale scores, treatment assignment indicators, and visit-level timepoint data. Direct identifiers will not be shared.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Changes in mania symptoms | Change in mania symptoms will be measured as the difference in total score from baseline to 5-week follow-up on the Young Mania Rating Scale (YMRS). YMRS scores range from 0-60, with higher scores indicating greater manic symptom severity. | From enrollment to end of study at 5 weeks |
| Changes in suicidality | Suicidality will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), with changes evaluated based on trajectories and patterns of ideation and behavior responses from baseline to the 5-week follow-up. Higher response levels reflect greater suicidality symptom severity. | From enrollment to end of study at 5 weeks |
| Change in quality of life and functioning | Change from baseline in quality of life and functional outcomes, assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), a standardized self-report measure evaluating satisfaction and functioning across multiple life domains. Q-LES-Q-SF scores range from 14-70, with higher scores indicating greater quality of life and satisfaction. | From enrollment to end of study at 5 weeks |