Cognitive Behavior Intervention for Psychological Distress, Motivation and Quality of Life Among Individual With Smoking CessationCBIMPDQLISCNCT06192043
Cognitive Behavioral Interventions for Motivation, Psychological Distress and Quality of Life Among Individuals With Smoking Cessation: A Randomized Control Trial
A study testing Behavioral Psychoeducational Intervention in people with Cognitive Behavior Intervention for Psychological Distress, Motivation and Quality of Life Among Individual With Smoking Cessation, run by Government College University Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Cognitive Behavior Intervention for Psychological Distress, Motivation and Quality of Life Among Individual With Smoking Cessation
- What is being tested?
- Behavioral Psychoeducational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- Behavioral Psychoeducational Intervention
- Keywords
- Psychological Distress, Quality of Life, Motivation, Cognitive Behavior Therapy, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Psychoeducational InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Nov 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavior Intervention for Psychological Distress, Motivation and Quality of Life Among Individual With Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
- Investigators
- Qasir Abbas, PHD, Principal investigator, Government College University Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192043
- Sponsor's protocol ID
- Govt.GCUF
- Acronym
- CBIMPDQLISC
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Interventions for Motivation, Psychological Distress and Quality of Life Among Individuals With Smoking Cessation: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06192043
- Acronym / sponsor ID
- CBIMPDQLISC / Govt.GCUF
- Keywords
- Psychological Distress, Quality of Life, Motivation, Cognitive Behavior Therapy, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental treatment group | Experimental | Behavioral: Behavioral Psychoeducational InterventionExperimental 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 |
| No intervention Control Group | No intervention | –Control Group: Participants in the control group didn't receive any Psychoeducational Intervention or any treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Psychoeducational InterventionPsychoeducational 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 | Behavioural | Experimental treatment group |
Primary outcome
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).
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.
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qasir Abbas, PHD principal investigator
Government College University Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Psychoeducational Intervention in people with Cognitive Behavior Intervention for Psychological Distress, Motivation and Quality of Life Among Individual With Smoking Cessation, run by Government College University Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.