Cognitive Behavioral Interventions for Motivation, Psychological Distress and Quality of Life Among Individuals With Smoking Cessation: A Randomized Control Trial (CBIMPDQLISC)

January 4, 2024 updated by: Qasir Abbas, Government College University Faisalabad
The main purpose of this research is to find out how brief cognitive behavior intervention influences the motivation level, psychological distress, and quality of life among people with smoking cessation. Another objective of this research is to examine the effectiveness of cognitive behavioral therapy (CBT) among smoking people, another objective of this study is to investigate how Cognitive behavioral therapy helps to enhance the motivation level and quality of life and minimize psychological distress among people with smoking cessation

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants:

This was basically pre and post study, initially 60 sixty research participants were recruited for pre-assessment, while 4 participants left due to some reasons (2 persons went out of the city for a job, 1 person met a severe road accident, and 1 person simply refused to participate in this study furthermore. Finally, 55 research participants were recruited for post-assessment. These research participants belong to different residential areas (rural/urban) have varied family systems (nuclear/joint) have different birth order, education, socioeconomic status, education, occupation, marital status, and distant smoking duration. The data were analyzed with the help of SPSS-23 (Statistical Package for Social Sciences - 23) descriptive statistics, correlation analysis, and repeated measure ANOVA were used to understand the association and differences among pre and post-assessment of smoking personals.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 37000
        • GCUF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • If we talk about inclusion criteria, the individuals who were ready to change their lives were part of this study, furthermore, persons above 18 years and below 60 years old were recruited for this study, minimum duration for smoking personnel was not less than 6 months and not more than 5 years were part of this study. The individuals who have signed a written informed consent form were part of this study. Moreover, only males who were easily comprehended and understood the instructions of the researcher were recruited in this study. On the other hand, if we talk about the exclusion criteria of the study

Exclusion Criteria:

  • the individuals who were reluctant to participate, or had any kind of psychophysiological illness prior to the study were excluded from this research. Further, the people below 18 and above 60 years were excluded. Furthermore, the research participants who had any kind of trauma during this study were excluded and those who refused to become further part of this study were excluded from this research study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental treatment group

Experimental Group:

Participants in the experimental group would receive 6-8 sessions of Psychoeducational based program

Waitlist Control group:

Participants in the control group would not receive a psychoeducational-based Program
Behavioral: Behavioral Psychoeducational Intervention
Psychoeducational Program would be used as an intervention strategy for individuals with smoking cessation to provide understanding and insight to the participants about the problem. Furthermore, this program would deal with interventions like motivation, cognitive conceptualization, coping skills and training, craving management, and relapse prevention among individuals with smoking cessation
No Intervention: No intervention Control Group

Control Group:

Participants in the control group didn't receive any Psychoeducational Intervention or any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time Frame: 6 months
The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) was developed under the supervision of WHO (World Health Organization) by a group of researchers, clinicians, public health providers in 2010 (WHO, 2010). It mainly screens out the individual tendency to use Alcohol, Tabaco and other substances. This test mainly has seven items, which shows good test-retest reliability ranging from 0.6 to 0.8 (Humeniuk, 2008).
6 months
Cigarette Dependency scale (CDS)
Time Frame: 6 months
The CDS (Cigarette Dependency scale) was developed by Jean-Francois Etter, PhD in 2003. (CDS; Etter et al.,2023). This scale has twelve items which gauge the addiction level, smoking compulsion, tolerability and withdrawal tendency of a person.
6 months
Depression Anxiety Stress Scale (DASS)
Time Frame: 6 months
The (DASS) Depression Anxiety Stress Scale was developed in the University of New South Wales Australia to assess the level of depression, anxiety and stress among students. The DASS-21 was developed by Lovibond and Lovibond in 1995 (Minh Thi Hong Le, 2017). In this study the Urdu translated version of DASS was used which were translated by Naeem and Kamal in 2018 (Naeem and Kamal, 2018). It is very reliable and valid tool to assess negative emotional state of depression, stress and anxiety. The overall reliability of DASS is 0.74.
6 months
Motivation and Attitude towards changing Health (MATCH)
Time Frame: 6 months
The MATCH (Motivation and Attitude towards changing Health) was developed by Hessler, Fisher, Polonsky, Browyer and Potter in 2018 (Hessler DM, Fisher L, Polonsky WH, Browyer V & Potter M., 2018). It's basically consist 9 items with 5 points Likert's scale ranging from strongly disagree to strongly agree).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government College University Faisalabad

Investigators

  • Principal Investigator: Qasir Abbas, PHD, Government College University Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

April 10, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Govt.GCUF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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