NCT06192043

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

December 19, 2023

Last Update Submit

January 4, 2024

Conditions

Keywords

Psychological Distress, Quality of Life, Motivation, Cognitive Behavior Therapy, Smoking Cessation

Outcome Measures

Primary Outcomes (4)

  • Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    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)

    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)

    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)

    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

Study Arms (2)

Experimental treatment group

EXPERIMENTAL

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

No intervention Control Group

NO INTERVENTION

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

Interventions

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

Experimental treatment group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GCUF

Faisalābad, Punjab Province, 37000, Pakistan

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Qasir Abbas, PHD

    Government College University Faisalabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control trial would be used in this study. It would be two two-arm study and two groups: The experimental and the control group. The experimental group will receive an intervention waitlist. In this research, a parallel group design will be used. We will give treatment to all participants in a parallel way. The allocation ratio and framework would be equivalence i.e., the treatment group and control group would be an equal number of participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Qaisir Abbas Assisstant Professor Clinical Psychology

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

November 15, 2023

Primary Completion

February 1, 2024

Study Completion

April 10, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations