Substance Use BehaviorNCT07884422
Cognitive Behavioral Therapy for Substance Use and Mental Health in University Students
A study testing Cognitive-Behavioral Therapy (CBT)-Based Group Intervention and Group Counseling Program in people with Substance Use Behavior, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
This study examined changes in substance use frequency, psychological well-being, and psychological symptoms among university students participating in a cognitive-behavioral therapy (CBT)-based group intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Behavior
- What is being tested?
- Cognitive-Behavioral Therapy (CBT)-Based Group Intervention and Group Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2026to 5 Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a university student aged 18 years or older.
- Voluntarily agreeing to participate in the study.
- Providing written informed consent.
- Being available to participate in the scheduled study activities and assessments.
Who cannot join
- Being unable to attend the scheduled group sessions because of timetable conflicts, employment, or health-related circumstances.
- Declining or withdrawing voluntary participation.
- Being unwilling to participate in a group-based intervention.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, Burdur, 15030
About this study
Official title: Effects of a Cognitive-Behavioral Therapy-Based Program on Substance Use, Well-Being, and Psychological Symptoms
This study examined changes in substance use frequency, psychological well-being, and psychological symptoms among university students participating in a cognitive-behavioral therapy (CBT)-based group intervention.
A total of 90 university students participated in a three-group, non-randomized, quasi-experimental study. Participants were allocated according to their availability for scheduled sessions. The CBT group included 34 students who participated in seven weekly sessions lasting approximately 90 minutes each. The inactive control group included 33 students who received no intervention. The active comparison group included 23 students who participated in seven group counseling sessions focusing on personal development, communication, time management, motivation, and study skills.
Read more
Participants completed measures of substance use frequency, psychological well-being, and psychological symptoms before the intervention, after the intervention, and at a three-month follow-up.
The study aimed to compare changes in these outcomes across the three groups. Because group allocation was not randomized, the findings cannot establish that the intervention caused the observed changes.
Read the detailed description
This study used a three-group quasi-experimental design with pretest, posttest, and three-month follow-up assessments to examine substance use frequency, psychological well-being, and psychological symptoms among university students.
Participants were recruited through university announcements and posters. Ninety volunteers participated in the study. Allocation to the three conditions was based on participants' availability for scheduled sessions rather than random assignment.
The CBT intervention group (n = 34) participated in seven weekly group sessions, each lasting approximately 90 minutes. The sessions addressed group orientation and an introduction to CBT in the context of substance use; relationships among situations, emotions, perceptions, and behaviors; cross-sectional case formulation; automatic thoughts, cognitive distortions, and cognitive restructuring; behavioral techniques and coping skills; problem-solving and life skills; and consolidation of gains and relapse prevention.
The inactive control group (n = 33) received no intervention during the study period.
The active comparison group (n = 23) participated in seven group counseling sessions addressing personal development, communication, time management, motivation, and study skills. Both active programs were facilitated by the principal investigator.
Data were collected at baseline, immediately after the intervention period, and approximately three months after completion of the intervention. Substance use frequency was assessed using three self-report items concerning tobacco or nicotine use, heavy episodic alcohol consumption, and nonmedical prescription medication use during the preceding 12 months. Psychological well-being and psychological symptoms were assessed using self-report measures.
The study was conducted without random assignment. Consequently, potential selection bias and differences between the groups must be considered when interpreting the findings.
- Conditions
- Substance Use Behavior
- Being tested
- Cognitive-Behavioral Therapy (CBT)-Based Group Intervention, Group Counseling Program
- Keywords
- Cognitive Behavioral Therapy, University Students, Substance Use, Psychological Well-Being, Psychological Symptoms, Group Counseling
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy (CBT)-Based Group InterventionBehavioural
The intervention consisted of seven weekly group sessions, each lasting approximately 90 minutes. The program addressed cognitive-behavioral principles related to substance use, relationships among situations, emotions, perceptions, and behaviors, cognitive restructuring, behavioral coping strategies, problem-solving skills, and relapse prevention. The sessions were delivered by the principal investigator.
Group Counseling ProgramBehavioural
The intervention consisted of seven group counseling sessions focusing on personal development, communication skills, time management, motivation, and study skills. The sessions were facilitated by the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| CBT-Based Intervention Group | Experimental | The experimental group consisted of 34 university students who received a seven-session cognitive-behavioral therapy (CBT)-based group intervention. Sessions were conducted once weekly and lasted approximately 90 minutes each. The program addressed CBT principles related to substance use, relationships among situations, emotions, perceptions, and behaviors, cognitive restructuring, behavioral coping strategies, problem-solving skills, and relapse prevention. The intervention was delivered by the principal investigator. Receives: Behavioral: Cognitive-Behavioral Therapy (CBT)-Based Group Intervention |
| No-Intervention Control Group | No intervention | The no-intervention control group consisted of 33 university students who did not receive a structured psychological intervention during the study period. Participants completed the same outcome assessments as the other groups at baseline, posttest, and three-month follow-up. |
| Group Counseling Comparison Group | Active comparator | The active comparison group consisted of 23 university students who participated in seven group counseling sessions focusing on personal development, communication skills, time management, motivation, and study skills. The sessions were facilitated by the principal investigator. Participants completed outcome assessments at baseline, posttest, and three-month follow-up. Receives: Behavioral: Group Counseling Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use Frequency
The outcome was assessed using a three-item self-report substance use frequency questionnaire measuring the frequency of tobacco/nicotine use, heavy episodic alcohol consumption, and nonmedical prescription medication use during the past 12 months. Each item was scored from 1 (never) to 5 (daily), yielding a total score ranging from 3 to 15. Higher scores indicate more frequent substance use.
Measured: Baseline, immediately after the 7-week intervention, and 3-month follow-up.
Secondary outcomes (2)
Psychological Well-Being
Psychological well-being was assessed using a 12-item self-report measure covering hedonic and eudaimonic dimensions of well-being. Higher scores indicate greater psychological well-being. Hedonic and eudaimonic scores were analyzed separately.
Measured: Baseline, immediately after the 7-week intervention, and 3-month follow-up.
Psychological Symptoms
Psychological symptoms were assessed using an 18-item self-report symptom inventory covering somatization, depression, and anxiety. Higher scores indicate greater symptom severity. The three symptom dimensions were analyzed separately.
Measured: Baseline, immediately after the 7-week intervention, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start12 Jan 2026
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use BehaviorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study employed a three-arm, non-randomized, parallel-group quasi-experimental design with pretest, posttest, and three-month follow-up assessments. Participants were assigned to groups based on their availability for scheduled sessions. The groups consisted of a CBT-based intervention group (n=34), a no-intervention control group (n=33), and an active group counseling comparison group (n=23).
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan ACAR, Mehmet Akif Ersoy University
- Investigators
- Hakan ACAR, PhD, Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884422
- Sponsor's protocol ID
- MAKU-CBT-SU-2025-01
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the dataset contains sensitive information about substance use and psychological symptoms, and there is no established plan for sharing participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cognitive-Behavioral Therapy-Based Program on Substance Use, Well-Being, and Psychological Symptoms
- ClinicalTrials.gov ID
- NCT07884422
- Acronym / sponsor ID
- MAKU-CBT-SU-2025-01
- Conditions
- Substance Use Behavior
- Keywords
- Cognitive Behavioral Therapy, University Students, Substance Use, Psychological Well-Being, Psychological Symptoms, Group Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 20 Oct 2026 (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.
This study examined changes in substance use frequency, psychological well-being, and psychological symptoms among university students participating in a cognitive-behavioral therapy (CBT)-based group intervention.
A total of 90 university students participated in a three-group, non-randomized, quasi-experimental study. Participants were allocated according to their availability for scheduled sessions. The CBT group included 34 students who participated in seven weekly sessions lasting approximately 90 minutes each. The inactive control group included 33 students who received no intervention. The active comparison group included 23 students who participated in seven group counseling sessions focusing on personal development, communication, time management, motivation, and study skills.
Participants completed measures of substance use frequency, psychological well-being, and psychological symptoms before the intervention, after the intervention, and at a three-month follow-up.
The study aimed to compare changes in these outcomes across the three groups. Because group allocation was not randomized, the findings cannot establish that the intervention caused the observed changes.
Detailed description
This study used a three-group quasi-experimental design with pretest, posttest, and three-month follow-up assessments to examine substance use frequency, psychological well-being, and psychological symptoms among university students.
Participants were recruited through university announcements and posters. Ninety volunteers participated in the study. Allocation to the three conditions was based on participants' availability for scheduled sessions rather than random assignment.
The CBT intervention group (n = 34) participated in seven weekly group sessions, each lasting approximately 90 minutes. The sessions addressed group orientation and an introduction to CBT in the context of substance use; relationships among situations, emotions, perceptions, and behaviors; cross-sectional case formulation; automatic thoughts, cognitive distortions, and cognitive restructuring; behavioral techniques and coping skills; problem-solving and life skills; and consolidation of gains and relapse prevention.
The inactive control group (n = 33) received no intervention during the study period.
The active comparison group (n = 23) participated in seven group counseling sessions addressing personal development, communication, time management, motivation, and study skills. Both active programs were facilitated by the principal investigator.
Data were collected at baseline, immediately after the intervention period, and approximately three months after completion of the intervention. Substance use frequency was assessed using three self-report items concerning tobacco or nicotine use, heavy episodic alcohol consumption, and nonmedical prescription medication use during the preceding 12 months. Psychological well-being and psychological symptoms were assessed using self-report measures.
The study was conducted without random assignment. Consequently, potential selection bias and differences between the groups must be considered when interpreting the findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study employed a three-arm, non-randomized, parallel-group quasi-experimental design with pretest, posttest, and three-month follow-up assessments. Participants were assigned to groups based on their availability for scheduled sessions. The groups consisted of a CBT-based intervention group (n=34), a no-intervention control group (n=33), and an active group counseling comparison group (n=23).
| Arm | Type | Receives |
|---|---|---|
| CBT-Based Intervention Group | Experimental | Behavioral: Cognitive-Behavioral Therapy (CBT)-Based Group InterventionThe experimental group consisted of 34 university students who received a seven-session cognitive-behavioral therapy (CBT)-based group intervention. Sessions were conducted once weekly and lasted approximately 90 minutes each. The program addressed CBT principles related to substance use, relationships among situations, emotions, perceptions, and behaviors, cognitive restructuring, behavioral coping strategies, problem-solving skills, and relapse prevention. The intervention was delivered by the principal investigator. |
| No-Intervention Control Group | No intervention | –The no-intervention control group consisted of 33 university students who did not receive a structured psychological intervention during the study period. Participants completed the same outcome assessments as the other groups at baseline, posttest, and three-month follow-up. |
| Group Counseling Comparison Group | Active comparator | Behavioral: Group Counseling ProgramThe active comparison group consisted of 23 university students who participated in seven group counseling sessions focusing on personal development, communication skills, time management, motivation, and study skills. The sessions were facilitated by the principal investigator. Participants completed outcome assessments at baseline, posttest, and three-month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a university student aged 18 years or older.
- Voluntarily agreeing to participate in the study.
- Providing written informed consent.
- Being available to participate in the scheduled study activities and assessments.
Key exclusion criteria (3 listed)
- Being unable to attend the scheduled group sessions because of timetable conflicts, employment, or health-related circumstances.
- Declining or withdrawing voluntary participation.
- Being unwilling to participate in a group-based intervention.
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 |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT)-Based Group InterventionThe intervention consisted of seven weekly group sessions, each lasting approximately 90 minutes. The program addressed cognitive-behavioral principles related to substance use, relationships among situations, emotions, perceptions, and behaviors, cognitive restructuring, behavioral coping strategies, problem-solving skills, and relapse prevention. The sessions were delivered by the principal investigator. | Behavioural | CBT-Based Intervention Group |
| Group Counseling ProgramThe intervention consisted of seven group counseling sessions focusing on personal development, communication skills, time management, motivation, and study skills. The sessions were facilitated by the principal investigator. | Behavioural | Group Counseling Comparison Group |
Primary outcome
Substance Use Frequency
Time frame: Baseline, immediately after the 7-week intervention, and 3-month follow-up.
The outcome was assessed using a three-item self-report substance use frequency questionnaire measuring the frequency of tobacco/nicotine use, heavy episodic alcohol consumption, and nonmedical prescription medication use during the past 12 months. Each item was scored from 1 (never) to 5 (daily), yielding a total score ranging from 3 to 15. Higher scores indicate more frequent substance use.
2 secondary outcomes
Psychological Well-Being
Time frame: Baseline, immediately after the 7-week intervention, and 3-month follow-up.
Psychological Symptoms
Time frame: Baseline, immediately after the 7-week intervention, and 3-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the dataset contains sensitive information about substance use and psychological symptoms, and there is no established plan for sharing participant-level data.
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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.
Hakan ACAR, PhD principal investigator
Burdur Mehmet Akif Ersoy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy (CBT)-Based Group Intervention and Group Counseling Program in people with Substance Use Behavior, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Oct 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Substance Use Frequency (time frame: Baseline, immediately after the 7-week intervention, and 3-month follow-up.). 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 20 Oct 2026.