NCT02153775

Brief Summary

Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 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

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

May 26, 2014

Last Update Submit

May 31, 2014

Conditions

Keywords

Progressive muscle relaxationCigaretteSmokingCraving

Outcome Measures

Primary Outcomes (1)

  • Craving

    Craving, a strong desire for using a substance when abstaining from substance, was measured by the Penn Alcohol Rating Scale - adapted (PACS-adapted) and the Visual Analog Scale (VAS).

    Immediately after a 20-minutes session of progressive muscle relaxation

Secondary Outcomes (1)

  • Cigarette withdrawal-related and non-withdrawal related feelings

    Immediately after a 20-minutes session of progressive muscle relaxation

Other Outcomes (2)

  • Blood pressure

    Immediately after a 20-minutes session of progressive muscle relaxation

  • Pulse rate

    Immediately after a 20-minutes session of progressive muscle relaxation

Study Arms (2)

Progressive muscle relaxation

EXPERIMENTAL

Progressive muscle relaxation: single 20-minutes session

Behavioral: Progressive Muscle Relaxation

Reading newspaper of the day

NO INTERVENTION

Reading newspaper of the day : single 20-minutes session

Interventions

Comparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time.

Progressive muscle relaxation

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or more
  • Daily cigarette smokers

You may not qualify if:

  • Hospitalization
  • Participating in cigarette dependency treatment or trying to quit smoking with other methods
  • Uncontrolled blood pressure
  • Current other substance users (except alcohol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Limsanon T, Kalayasiri R. Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial. Behav Ther. 2015 Mar;46(2):166-76. doi: 10.1016/j.beth.2014.10.002. Epub 2014 Nov 7.

Related Links

MeSH Terms

Conditions

Behavior, AddictiveSmoking

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thatsanee Limsanon, M.Sc.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 26, 2014

First Posted

June 3, 2014

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations