Relapse Prevention Through Social Networking Groups

Smoking Clinical Trial

Official title:

Effectiveness of Using Social Networking Service to Prevent Smoking Relapse Among Self-reported Quitters: A Pilot Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007369
• Other study ID #: TWRP2013
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: April 28, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

According to the Census & Statistics Department, there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they could not maintain abstinence. Relapse prevention is aimed at providing interventions to prevent relapse after starting the abstinence status. This pilot single-blind randomized controlled trial (proof of concept study) will test the effectiveness of social networking services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for a qualitative interview for the design of intervention. Then, the pilot-RCT trial will recruit 120 participants who have recently quitted smoking, and they will be randomly allocated to 2 intervention groups and one control group. The 2 intervention groups will be arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group moderators and sharing quitting experience with other participants. All participants will receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3 months and 6 months. The primary outcome is the self-report relapse rate (Relapse is tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among the 3 study arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smoked at least 1 cigarette a day when first joined ICSC

• Aged 18 or above at the baseline of the RCT

• Clients who have received 3 to 5 smoking cessation counseling provided by ICSC

• Reported tobacco abstinence in the past 7 days at the 8-week follow-up since receiving treatment from ICSC

• Able to communicate in Cantonese and read Chinese

• Have a local network mobile phone with mobile internet access

Exclusion Criteria:

• Those with unstable physical or psychological conditions as advised by the doctor or counselor in charge

• Smokers with diagnosed alcohol dependence by clinicians or the score of the Alcohol Use Disorders Identification Test (AUDIT) is 8 or higher

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Peer to peer support and delivery of information through WhatsApp groups
Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. In addition to the information delivered by the moderators, the moderators will encourage other participants to support each other and discuss certain topics related to smoking and quitting. Also, moderators of the social groups will send messages of brief advice, give feedback to participants' enquiries and facilitate conversations in the platform. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 6 weeks.
• Peer to peer support and delivery of information through Facebook
Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy.

Locations

Country	Name	City	State
China	Integrated Centres on Smoking Cessation (ICSC), Tung Wah Groups of Hospital (TWGH)	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Tung Wah Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported relapse rate (Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting (Van Zundert, Kuntsche, & Engels, 2012))		6 weeks, 3 months and 6 months after joining the groups for the social networking services.	Yes
Secondary	Point prevalence of self-reported abstinence for the previous 7 and 30 days		6 weeks	Yes
Secondary	Self reported relapse rate (Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting (Van Zundert, Kuntsche, & Engels, 2012))		3 months	Yes
Secondary	Self reported relapse rate (Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting (Van Zundert, Kuntsche, & Engels, 2012))		6 months	Yes