NCT02901171

Brief Summary

The purpose of this study is to evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study also aims to elucidate the processes through which the treatment promotes smoking cessation and for whom it is most effective.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

September 9, 2016

Last Update Submit

July 27, 2018

Conditions

Smoking

Keywords

Smoking cessationAcceptance and Commitment TherapySmartphone

Outcome Measures

Primary Outcomes (2)

  • Seven-day point-prevalence abstinence

    6 weeks after beginning treatment

  • Seven-day point-prevalence abstinence

    6 months after beginning treatment

Secondary Outcomes (4)

  • Positive mental health measured by the Mental Health Continuum-Short Form

    6 weeks after beginning treatment

  • Positive mental health measured by the Mental Health Continuum-Short Form

    6 months after beginning treatment

  • Cigarettes per day in non-abstinent participants

    6 weeks after beginning treatment

  • Cigarettes per day in non-abstinent participants

    6 months after beginning treatment

Study Arms (3)

Combined Treatment

EXPERIMENTAL

ACT group treatment combined with smartphone application

Behavioral: ACT group treatment combined with smartphone application

Acceptance and Commitment Therapy (ACT)

ACTIVE COMPARATOR

ACT group treatment

Behavioral: ACT group treatment

Behavioural Support Programme

ACTIVE COMPARATOR

Group based Behavioural Support Programme

Behavioral: Group based Behavioural Support Programme

Interventions

ACT group treatment combined with smartphone applicationBEHAVIORAL

The Acceptance and Commitment Therapy (ACT) group treatment for smoking cessation will be delivered in six weekly 90-min sessions. Smoking cessation will be promoted in each session by targeting core processes of the ACT model including acceptance, cognitive defusion, mindfulness, flexible perspective taking, values clarification and committed action. In addition, participants will receive an ACT-based smartphone application for smoking cessation. The application will foster core processes of the ACT model through daily exercises, tips and tools.

Combined Treatment
ACT group treatmentBEHAVIORAL
Acceptance and Commitment Therapy (ACT)
Group based Behavioural Support ProgrammeBEHAVIORAL

The Behavioural Support Programme will be facilitated by stop smoking experts and delivered in six weekly 90-min sessions in a group format. During the sessions, advice, support and information on smoking cessation will be given to participants and behavioural techniques will be reviewed.

Behavioural Support Programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Interested in quitting smoking in the next 30 days
  • Smoking 10 or more cigarettes per day for at least the past 12 months
  • Daily access to a smartphone that is compatible with applications from iTunes (iPhone) or Google Play (Android)

You may not qualify if:

  • Currently participating in another smoking cessation intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Leinster, Ireland

Location

Related Publications (1)

  • Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

    PMID: 35420700DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Louise McHugh, Ph.D.

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

IE(1)