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iACT & iTBS for Sleep Quality in Depressed Adolescents
Sponsor: Central China Normal University
Summary
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.
Official title: Internet-Delivered ACT and Intermittent Theta Burst Stimulation for Subjective Sleep Quality in Depressed Adolescents: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
11 Years - 19 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2023-08-01
Completion Date
2024-01-30
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Internet-Delivered Acceptance and Commitment Therapy
Participants received a self-guided internet-delivered Acceptance and Commitment Therapy program through a custom-developed WeChat mini-program over 12 consecutive days. The program included an introduction, six sequential treatment modules, and a concluding session. Modules were unlocked on days 1, 3, 5, 7, 9, and 11, and each component required approximately 15 minutes, for a total planned exposure of approximately 120 minutes. Content was based on the ACT hexaflex model and included psychoeducation, acceptance, cognitive defusion, mindfulness, values clarification, and values-consistent action. Participants completed the modules on site during daily hospital visits. Module completion and practice activities were monitored through the mini-program and by research staff. A crisis hotline was embedded in the program.
Intermittent Theta Burst Stimulation
Intermittent theta burst stimulation was administered once daily for 12 consecutive days using a Magstim Rapid2 stimulator with a 70-mm figure-of-eight coil. The individualized stimulation target was located over the left dorsolateral prefrontal cortex using integrated neuronavigation, and the target coordinates were saved for subsequent sessions. Resting motor threshold was measured before treatment. Each daily session delivered 1,800 pulses in three blocks of 600 pulses. Stimulation consisted of three 50-Hz pulses repeated at 5 Hz in 2-second trains separated by 8-second intervals. Stimulation was delivered at 100% of the participant's resting motor threshold.
Locations (1)
Anhui Mental Health Center
Wuhan, Hubei, China