Virtual Reality Exposure Therapy in the Treatment of Alcohol Use Disorder

NCT05841823 | Not Yet Recruiting DMC

• 1 other identifier: XYEFYLL-(Research)-2022-29
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the efficacy of two types of interventions, which are acceptance and commitment therapy (ACT) as compared with virtual reality exposure therapy (VRET) for alleviating psychological dependence on alcohol and preventing relapse. It also assesses the changes of EEG in patients with alcohol use disorder after completion of the above related interventions. In this study 120 subjects with alcohol use disorder who have completed 2 weeks of in-patient detoxification will be randomized into three groups (VRET, ACT and treatment-as-usual control groups) and undergo respective interventions. Then assessment will be performed at four timelines (baseline, 4 weeks after baseline which is immediately after completion of intervention, 12 weeks after baseline, and 24 weeks after baseline assessment).

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorder; acceptance and commitment therapy; virtual reality exposure therapy; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Change in Alcohol Use Disorders Identification Test (AUDIT) score across four timelines

  This questionnaire can differentiate drinkers from mild to severe. The scale consists of 10 questions, of which three relate to the amount and frequency of alcohol consumption, three relate to alcohol dependence and four involve in various problems caused by alcohol. The score of the scale ≥ 8 is positive. In general, those with high scores on the first three questions but low scores on the rest suggest serious harmful drinking; High scores in questions 4, 5 and 6 indicate alcohol dependence; High scores in the final section indicate that drinking has caused harm. The reliability and validity of the Chinese version are 0.782. Factor analysis showed that indeed the Chinese version of the AUDIT comprised of three factors and had good convergent and discriminant validity. Total score ranged from 0 to 40.

  At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began

• Change in Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) score across four timelines

  The scale is a standard tool for quantifying the severity of alcohol withdrawal symptoms. The total score \< 10 suggests mild withdrawal reaction. The score of 10 to 20 indicates moderate. The total score of more than 20 is considered severe. A severe total score is associated with a risk of delirium tremens and seizures. The reliability of the Chinese version of CIWA-Ar was good with Cronbach's α of 0.83. Total score ranged from 0 to 30.

  At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began

• Change in Penn Alcohol Craving Scale (PACS) score across four timelines

  This questionnaire consists of five items to evaluate the severity of craving, including frequency, intensity, duration, difficulty of coping, and average craving degree. It is a seven-point scale from 0 to 6, with 0 being none and 6 being extremely severe. The subjects will be asked to answer questions according to the situation in the past week. The reliability of the Chinese version of PACS was good at Cronbach's α of 0.97. Total score ranged from 0 to 30.

  At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began

Secondary Outcomes (2)

• Change in Hamilton Anxiety Rating Scale (HAM-A) score across four timelines

  At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began

• Change in Hamilton Depression Rating Scale (HAM-D) score across four timelines

  At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began

Other Outcomes (1)

• Change in event-related potential (ERP) in EEG across four timelines

  At four time points of assessment: t0 (baseline) = before starting intervention, t1 = 4 weeks which is immediately after completion of intervention, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began

Study Arms (3)

Virtual reality exposure therapy (VRET)

EXPERIMENTAL

In this group, each session of VRET will last 25 minutes and consists of three parts: 5 minutes of relaxation, 10 minutes of exposure to high-risk situation and 10 minutes of exposure to aversive situation. Each participants will receive 20 sessions of VRET, 5 sessions per week for 4 weeks.

Behavioral: Virtual reality exposure therapy (VRET)

Acceptance and commitment therapy (ACT)

ACTIVE COMPARATOR

In this group, participants will receive a 50-minutes ACT session per week for 4 weeks. Hence, a total of 4 sessions will be administered to each participant.

Behavioral: Acceptance and commitment therapy (ACT)

Treatment-as-usual control (TAU)

NO INTERVENTION

While for the control group, participants will receive non-specific ingredients of the psychotherapeutic approach schedule at a 50-minutes session per week for 4 weeks.

Interventions

Virtual reality exposure therapy (VRET) BEHAVIORAL

The relaxation scene includes four beautiful landscapes, and patients can choose any of these four, as perceived to be the most comfortable landscape. The visual stimulation of high-risk scene is designed as any combination of four different scenes (street barbecue stands, restaurant, bar and home) and four kinds of alcoholic beverages (Chinese liquor, beer, grape wine and cocktail), which are customized according to the patient's personal preference. At the same time, the odor of the alcoholic beverage of the patient's choice will be provided as an olfactory stimulation. The aversive situation will be the visual and auditory stimulation provided by a video of an alcoholic vomiting, while olfactory stimulation will be provided by cotton balls soaked in fermented dairy products.

Virtual reality exposure therapy (VRET)

Acceptance and commitment therapy (ACT) BEHAVIORAL

The initial session began with case formulation. Subsequent sessions involved learning on acceptance and acknowledgement of unpleasant thoughts and feelings associated with alcohol craving and clinical features of alcohol use disorder, cognitive defusion on how to dissociate self avoidance of unpleasant thoughts and feelings, learning and practicing mindfulness exercise (such as mindfulness breathing) to make self aware of the many things that occurred presently which can be enjoyed and focus on rather than focusing on unpleasant thoughts and feelings, and learning to be aware of the safe self which is separated from the unpleasant thoughts and feelings and identifying values in life and strategies to achieve these values (therapeutic processes in hexaflex).

Acceptance and commitment therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only male subjects are recruited
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hospitalized patients diagnosed with alcohol use disorder (confirmed by the relevant diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders-V).
• Male, age 18 to 55 years old, Han nationality, junior high school education or above, right-handed (because of the difference in EEG between right-hand and left-hand).
• Those with normal eyesight (including corrected vision).

You may not qualify if:

• Those with current and lifetime history of abuse of any other psychoactive substances (except tobacco).
• Those with current and lifetime history of other mental diseases.
• Those with current and lifetime history of central nervous system diseases or serious physical illnesses.
• Those who are unable to complete the EEG detection or psychological scale assessment.
• Those who are unable to cooperate with ACT or VRET, or who are seriously uncomfortable with psychotherapy.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Xinxiang medical university: collaborator

Related Publications (1)

• Deng H, Zhang R, Wang C, Zhang B, Wang J, Wang S, Zhang J, Shari NI, Leong Bin Abdullah MFI. The efficacy of virtual reality exposure therapy for the treatment of alcohol use disorder among adult males: a randomized controlled trial comparing with acceptance and commitment therapy and treatment as usual. Front Psychiatry. 2023 Aug 22;14:1215963. doi: 10.3389/fpsyt.2023.1215963. eCollection 2023.

  PMID: 37674551 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Virtual Reality Exposure Therapy; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy

Study Officials

• Mohammad Farris Iman Leong Bin Abdullah, Dr Psych

  Advanced Medical and Dental Institute, Universiti Sains Malaysia (USM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Farris Iman Leong Bin Abdullah, Dr Psych

CONTACT

+60186669950; farris@usm.my

Hongdu Deng, MD

CONTACT

+86-139 2827 9403

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation sequence is concealed in opaque, sequential numbered envelope. The randomization will be carried out by the research assistant which is not involved in the study. The data collection will also be carried out by the research assistant who did not know about the objective of the study. Hence, this is a three-armed parallel group single blind randomized controlled trial. The subjects are not blinded as they would have known which intervention they are in as the intervention procedures are different.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: multicenter, three-armed, parallel, single blind randomized control trial

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 3, 2023
• Study Start: June 1, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share