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Ensaio clínico

iACT & iTBS for Sleep Quality in Depressed Adolescents

NCT: NCT07807072 · COMPLETED

ID NCTNCT07807072
EstadoCOMPLETED
Data de início2023-08-01
Conclusão2024-01-30
SponsorCentral China Normal University (OTHER)
First posted
Last updated

Resumo breve

This study evaluated whether combining an internet-delivered Acceptance and Commitment Therapy program with intermittent theta burst stimulation improves subjective sleep quality in adolescents with depressive disorders and sleep disturbances. Acceptance and Commitment Therapy is a psychological treatment that teaches skills for accepting difficult thoughts and feelings, reducing unhelpful struggle with them, and taking actions consistent with personal values. Intermittent theta burst stimulation is a brief, noninvasive form of brain stimulation delivered over the left dorsolateral prefrontal cortex. A total of 152 adolescents aged 11 to 19 years were randomly assigned to one of four groups: combined internet-delivered Acceptance and Commitment Therapy plus intermittent theta burst stimulation, internet-delivered Acceptance and Commitment Therapy alone, intermittent theta burst stimulation alone, or a waitlist control group. Treatment was provided over 12 consecutive days. Participants completed assessments before treatment, immediately after treatment, and 30 days later. The study was registered retrospectively after participant recruitment and data collection had begun. The primary outcome was subjective sleep quality, measured with the Pittsburgh Sleep Quality Index. Secondary outcomes were depressive symptom severity and psychological flexibility. The study also assessed treatment exposure and adverse events, including headache or scalp discomfort associated with brain stimulation.

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