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iACT & iTBS for Sleep Quality in Depressed Adolescents

CompletedNA

Sponsor: Central China Normal University

Conditions: Depressive Disorder, Sleep Disturbance

Interventions: Internet-Delivered Acceptance and Commitment Therapy, Intermittent Theta Burst Stimulation

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 11 Years to 19 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age 11 to 19 years.
2. A primary depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by independent evaluations conducted by two board-certified psychiatrists using semistructured clinical interviews. Any discrepancy was adjudicated by a senior psychiatrist.
3. Hamilton Depression Rating Scale, 17-item version (HAMD-17) score of at least 8.
4. Current subjective sleep disturbance, including difficulty initiating sleep, frequent nighttime awakenings, or nonrestorative sleep, confirmed during the diagnostic interview.
5. Either no antidepressant medication or stable antidepressant pharmacotherapy for at least 2 weeks before enrollment.
6. No concurrent systematic psychological or physical treatment during the study.
7. Right-handedness.
8. Written informed consent from a parent or legal guardian and written assent from the adolescent participant.

Exclusion Criteria:

1. History of epilepsy, major neurological disorder, or any contraindication to transcranial magnetic stimulation, including relevant metal implants.
2. Acute suicide risk requiring immediate clinical intervention.
3. Substance use disorder within the previous year.
4. Severe somatic illness that could interfere with study participation or outcome assessment.
5. Current use of targeted hypnotic or sedative medication.

Locations (1)

Wuhan, Hubei, China