Theta Burst Stimulation in the Management of Methamphetamine Use Disorder in Indonesia

Keywords

• Methamphetamine Use Disorder
• Theta Burst Stimulation
• Cognitive Behavioral Therapy
• Transcranial Magnetic Stimulation

Lead sponsor

Universitas Indonesia is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Study arms

• Experimental
  TBS and CBT

  During 12 days of intervention, the participants underwent 10 sessions of TBS and 12 sessions for CBT.

  Device: Theta Burst Stimulation · Behavioral: Cognitive Behavioral Therapy

• Sham comparator
  Sham and CBT

  During 12 days of intervention, the participants underwent 10 sessions of sham TBS and 12 sessions of CBT.

  Device: Theta Burst Stimulation · Behavioral: Cognitive Behavioral Therapy

Interventions

• DeviceTheta Burst Stimulation

  A randomized controlled trial (RCT) of 20 participants underwent TBS and CBT intervention for MUD.

  Also known as: TBS, Transcranial Magnetic Stimulation, TMS

• BehavioralCognitive Behavioral Therapy

  The cognitive behavioral therapy (CBT) for methamphetamine use disorder (MUD) was conducted in 12 sessions (1 session per day). We utilized the module adapted from the Indonesia Drug Addiction and Relapse Prevention Program (Indo-DARPP) for MUD. The CBT was delivered by trained psychiatrist in group CBT setting.

  Also known as: CBT

Primary outcomes

1. Improvement in craving for methamphetamine

   Cue-induced craving was measured with Visual Analog Scale (VAS) where the patient told to indicate their point of craving in a 100 mm line. The scale ranged from 0 to 10, with higher scores indicated higher craving.

   Time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

2. Improvement in craving (tonic) for methamphetamine

   Tonic or baseline craving was measured using the Questionnaire for Smoking Urges modified for Methamphetamine (QSU-M) in Indonesian version. The questions were self-filled by the participants to identify their level of craving. The QSU-M is a 7-point Likert Scale (1 was strongly disagree and 7 was strongly agree) with the higher total scores indicating higher tonic craving. The total minimum score was 10 while the maximum score was 70.

   Time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

3. Improvement in clinical severity

   The clinical severity was measured using the Clinical Global Impression - Severity by the psychiatrist based on the patient's condition during the day of examination. CGI is a clinician-rated instrument used to assess the patient's condition based on clinical judgment. CGI mainly rates the severity of illness assessed using a 7-point Likert scale, ranges from 1 (normal) to 7 (among the most extremely ill). Higher score indicated higher severity of addiction-related illness.

   Time frame: Baseline (T1), day 3 (T2), day 5 (T3), day 8 (T4), and day 10 (T5)

Secondary outcomes

1. Improvement in Addiction Severity

   Addiction Severity Index (ASI) assessed the severity of a person's addiction, through multiple domains; medical, occupational, alcohol usage, substance use, law, family/social and mental status domains. The analysis utilized composite scores of relevant questions. Higher scores indicated higher severity. The minimum composite score for each domain was 0 while the maximum score was 1.

   Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

2. Improvement in Depressive Symptoms

   The Patient Health Questionnaire-9 (PHQ-9) assessed the severity of depressive symptoms, with higher scores indicating higher severity. PHQ-9 is a 9 item with 3-point Likert scale with 0 indicates no presence of symptoms and indicates higher frequency of depression symptoms (nearly every day). The higher total scores indicates higher severity of depression, with the minimum total score of 0 and the maximum score of 27.

   Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

3. Improvement in Motivation to Change

   University of Rhode Island Change Assessment (URICA) assessed a person's readiness for change, with scores divided into four subscales: pre-contemplation, contemplation, action and maintenance. URICA is a five-point Likert scale consisting of 32 questions, ranges from 1 (strongly disagree) to 5 (strongly agree). The minimum averaged score per subscale was 1 while the maximum score was 5. The calculation was done with the formula as follow: (averaged contemplation + averaged action + averaged maintenance)/averaged pre-contemplation. Higher overall score indicated higher stage of change.

   Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

4. Improvement in Impulsivity

   The Barratt Impulsiveness Scale version 11 (BIS-11) assesed impulsive attitudes and behaviors. BIS-11 was a four-point Likert scales of 30 items, ranged from 1 (never/very rarely), 2 (rarely), 3 (often), and 4 (almost always). The total scores ranged from 30 to 120. Higher scores indicate higher overall impulsivity.

   Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)

5. Improvement in Sleep Quality

   The Pittsburgh Sleep Quality Index (PSQI) assessed sleep quality, measuring subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. PSQI consisted of different segments of questions from sleep duration, habitual efficiency, and symptoms of sleeping problems. The symptoms were measured in 4-point Likert scale where 0 indicated no difficulty and 3 indicated high difficulty of sleeping. This instrument consisted of 19 questions, yielding a global score from 0 to 21. A higher total score indicated poor sleep quality.

   Time frame: Baseline (T1) and Post-Intervention Day 12 (T6)