iACT & iTBS for Sleep Quality in Depressed Adolescents

NCT07807072 | Completed

• 2 other identifiers: CCNU-IRB-202306017bhttps://osf.io/8ewc
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder; Sleep Disturbance

Keywords

Subjective sleep quality; depression; internet-delivered Acceptance and Commitment Therapy; intermittent Theta Burst Stimulation; psychological flexibility

Outcome Measures

Primary Outcomes (1)

• Change in subjective sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)

  Subjective sleep quality will be assessed with the 19-item Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer subjective sleep quality. The primary outcome is the change in PSQI total score from baseline to immediately after the 12-day intervention and from baseline to the 30-day follow-up. Negative change scores indicate improvement in subjective sleep quality.

  Baseline to immediately postintervention (day 12) and baseline to 30-day follow-up (day 42)

Secondary Outcomes (2)

• Change in depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17)

  Baseline to immediately postintervention (day 12) and baseline to 30-day follow-up (day 42)

• Change in psychological flexibility measured by the Multidimensional Psychological Flexibility Inventory-24 (MPFI-24)

  Baseline to immediately postintervention (day 12) and baseline to 30-day follow-up (day 42)

Study Arms (4)

Combined iACT and iTBS

EXPERIMENTAL

Participants received intermittent theta burst stimulation once daily for 12 consecutive days and completed six sequential internet-delivered Acceptance and Commitment Therapy modules on days 1, 3, 5, 7, 9, and 11. On module days, iTBS was administered immediately before the iACT module.

Behavioral: Internet-Delivered Acceptance and Commitment Therapy; Device: Intermittent Theta Burst Stimulation

iACT Only

EXPERIMENTAL

Participants completed six sequential internet-delivered Acceptance and Commitment Therapy modules over 12 days, with modules delivered on days 1, 3, 5, 7, 9, and 11.

Behavioral: Internet-Delivered Acceptance and Commitment Therapy

iTBS Only

EXPERIMENTAL

Participants received intermittent theta burst stimulation over the left dorsolateral prefrontal cortex once daily for 12 consecutive days.

Device: Intermittent Theta Burst Stimulation

Waitlist Control

NO INTERVENTION

Participants received no targeted study intervention during the 42-day study period and completed assessments at the same time points as the active intervention groups. Participants were offered access to the iACT program after the final follow-up assessment.

Interventions

Intermittent Theta Burst Stimulation DEVICE

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.

Also known as: iTBS, Intermittent TBS

Combined iACT and iTBS; iTBS Only

Internet-Delivered Acceptance and Commitment Therapy BEHAVIORAL

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.

Also known as: iACT, Internet-delivered ACT

Combined iACT and iTBS; iACT Only

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 11 to 19 years.
• 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.
• Hamilton Depression Rating Scale, 17-item version (HAMD-17) score of at least 8.
• Current subjective sleep disturbance, including difficulty initiating sleep, frequent nighttime awakenings, or nonrestorative sleep, confirmed during the diagnostic interview.
• Either no antidepressant medication or stable antidepressant pharmacotherapy for at least 2 weeks before enrollment.
• No concurrent systematic psychological or physical treatment during the study.
• Right-handedness.
• Written informed consent from a parent or legal guardian and written assent from the adolescent participant.

You may not qualify if:

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

Sponsors & Collaborators

• Central China Normal University: lead

Study Sites (1)

Anhui Mental Health Center

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Depressive Disorder; Parasomnias; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Zhihong Ren, PhD

  Central China Normal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 30, 2024
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)