Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Adult Drinkers

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05995470

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To determine the feasibility, acceptability, and preliminary effects of an internet-based DBT-ST for reducing alcohol consumption and improving psychological distress/emotional regulation in adult drinkers
To explore the participants' experiences and perceptions of the proposed intervention

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Behavioral: Internet-based dialectical behaviour therapy-informed skills training Behavioral: Monthly health education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Reducing Alcohol Consumption and Improving Psychological Distress of Adult Drinkers: A Pilot Randomised Controlled Trial

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DBT-ST group Participants in the intervention group will receive the DBT-ST by means of a free video-communication app. Over the next 13 weeks from the baseline, the intervention group will receive a weekly 120-minute internet-based DBT-ST focusing on the four modules of DBT-ST.	Behavioral: Internet-based dialectical behaviour therapy-informed skills training Adaptive applications of DBT-ST for drinkers with psychological distress
Other: TAU group Participants in the wait list control group will receive a monthly health education for three months that provides general health information and sharing sessions, which is one of the routine care for drinkers during the first 3-4 months after they seek help for drinking problem (waiting period for further intervention).	Behavioral: Monthly health education General health information and sharing sessions

Arm

Intervention/Treatment

Experimental: DBT-ST group

Participants in the intervention group will receive the DBT-ST by means of a free video-communication app. Over the next 13 weeks from the baseline, the intervention group will receive a weekly 120-minute internet-based DBT-ST focusing on the four modules of DBT-ST.

Behavioral: Internet-based dialectical behaviour therapy-informed skills training

Adaptive applications of DBT-ST for drinkers with psychological distress

Other: TAU group

Participants in the wait list control group will receive a monthly health education for three months that provides general health information and sharing sessions, which is one of the routine care for drinkers during the first 3-4 months after they seek help for drinking problem (waiting period for further intervention).

Behavioral: Monthly health education

General health information and sharing sessions

Outcome Measures

Primary Outcome Measures

Alcohol consumption [Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention]
The Chinese version of the Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Level of psychological distress [Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention]
Symptoms of depression, anxiety and stress

Secondary Outcome Measures

Self-reported alcohol abstinence [Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention]
Self-reporting of quitting
Emotion dysregulation [Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention]
Levels of emotion dysregulation
Distress tolerance [Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention]
Perceived ability to tolerate emotional distress
Coping response [Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention]
Self-report measure of coping strategies

Other Outcome Measures

Acceptability [Post-intervention (upon completion of the 13-week DBT-ST)]
Client Satisfaction
Feasibility of the intervention [Post-intervention (upon completion of the 13-week DBT-ST)]
1) Recruitment rate; (2) Intervention engagement in terms of time spent on each session and participation rates; and (3) Attrition rates
Semi-structured interview [Post-intervention (upon completion of the 13-week DBT-ST)]
Individual semi-structured interviews will be conducted at post-intervention to explore participants' experiences/perceptions of the internet-based DBT-ST, as well as their comments on the appropriateness/comprehensiveness of the content/frequency of the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Hong Kong Chinese aged ≥18
Score ≥8 on the Alcohol Use Disorders Identification Test
Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21
Have an intention to stop drinking
Have an electronic device and are willing to receive interventions via the internet