Internet-Delivered ACT and Intermittent Theta Burst Stimulation for Subjective Sleep Quality in Depressed Adolescents: A Randomized Controlled Trial

This was a four-arm, parallel-group, randomized controlled superiority trial conducted in the outpatient department of a psychiatric hospital in Anhui Mental Health Center. The study was retrospectively registered on the Open Science Framework in May 2024. The study protocol was approved by the institutional review board (Approval No.: CCNU-IRB-202306017b). Written informed consent was obtained from a parent or legal guardian, and written assent was obtained from each adolescent participant.

Participants were recruited by convenience sampling between August 2023 and January 2024. Eligible participants were 11 to 19 years old; had a primary DSM-5 depressive disorder confirmed by independent evaluations from two board-certified psychiatrists using semistructured clinical interviews; had a Hamilton Depression Rating Scale, 17-item version (HAMD-17) score of at least 8; and reported a concurrent subjective sleep disturbance, such as difficulty initiating sleep, frequent nighttime awakenings, or nonrestorative sleep. Participants were required either to be receiving stable antidepressant pharmacotherapy for at least 2 weeks or to be taking no antidepressant medication. Participants could not be receiving another systematic psychological or physical treatment and were required to be right-handed.

Participants were excluded for a history of epilepsy, a major neurological disorder, a contraindication to transcranial magnetic stimulation, acute suicide risk, a substance use disorder within the preceding year, severe somatic illness, or current use of targeted hypnotic or sedative medication.

Participants were randomly assigned in a 1:1:1:1 ratio using a computer-generated permuted-block randomization sequence. Allocation was managed by personnel independent of outcome assessment. Independent HAMD-17 raters were masked to treatment assignment. Participants and intervention-delivery personnel were not masked because the treatment formats and waitlist condition were distinguishable. Self-report outcome measures were completed by participants.

The internet-delivered Acceptance and Commitment Therapy program was provided through a custom-developed WeChat mini-program. The program included an introduction, six sequential treatment modules, and a concluding session. The content was delivered over 12 days and covered psychoeducation, acceptance, cognitive defusion, mindfulness, values clarification, and values-consistent action. The modules were unlocked on days 1, 3, 5, 7, 9, and 11, with approximately 15 minutes required for each component. The total planned exposure was approximately 120 minutes. All modules were completed on site during daily hospital visits. Online records and staff monitoring were used to document module completion and practice activities. A crisis hotline was embedded in the program.