AnxietynotNCT06464211
The Effect of Family Counseling Program on Anxiety and Conscious Awareness Levels
A study testing Cognitive Behavioral Model-Based Family Counseling Program in people with Anxiety and Awareness, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effect of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on the anxiety and mindfulness levels of university students experiencing future anxiety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Awareness, Family Therapy
- What is being tested?
- Cognitive Behavioral Model-Based Family Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 1 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The level of future anxiety is above 40 points
- No problems with speech, perception or hearing
- The person or persons who will be included in the study from family members will be able to participate in the online session at the time required for counseling
- The student will regularly participate in the interview sessions to be held
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Family Counseling Program Applied to University Students With Future Anxiety on Anxiety and Conscious Awareness Levels
This study investigates the effect of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on the anxiety and mindfulness levels of university students experiencing future anxiety. The research highlights the significance of university education in career development, noting the associated biopsychosocial challenges faced by students. These challenges often manifest as future anxiety-a condition characterized by fear, uncertainty, and stress about future prospects, which can impact students' academic performance, social relationships, and overall mental health. Literature reveals that interventions like CBT, mindfulness practices, and family counseling are effective in managing anxiety and enhancing emotional resilience. The program integrates these approaches to provide dual-layer support, addressing individual thought patterns and family dynamics, thus potentially reducing anxiety and increasing mindfulness among students. This study aims to provide a comprehensive understanding of the program's effectiveness in a controlled setting, contributing to both national and international literature on mental health interventions.
Read the detailed description
This research was conducted as a pre-test, post-test randomized controlled study to determine the effects of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on anxiety and mindfulness levels in university students experiencing future anxiety. The study collected data from 20 students, divided equally between 10 participants in the intervention group and 10 in the control group. Data were gathered using a Personal Characteristics Form, the Future Anxiety Scale for University Students, and the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults.
The intervention group participated in an online CBT-based Family Counseling Program, which was conducted weekly for 8 weeks, each session lasting between 50-60 minutes. For the first 6 weeks, the sessions included only the students, while the last two weeks also involved family members' participation. No intervention was applied to the control group. Both groups were assessed with the aforementioned scales before the intervention and after its conclusion. This study aims to provide insights into the effectiveness of integrating family dynamics into therapeutic practices for reducing anxiety and enhancing mindfulness among students.
- Conditions
- Anxiety, Awareness, Family Therapy, Cognitive Behavioral Therapy
- Being tested
- Cognitive Behavioral Model-Based Family Counseling Program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Model-Based Family Counseling ProgramBehavioural
A Cognitive Behavioral Model-Based Family Counseling Program is a therapeutic approach that focuses on identifying and changing negative thought patterns and behaviors within the family unit, using principles of cognitive-behavioral therapy to improve communication, resolve conflicts, and enhance overall family functioning.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | There were 6 face-to-face sessions with students for 50- 60 minutes/week, and 2 sessions with internet-based video programs with students' families. Cognitive Behavioral Model-Based Family Counseling Program was conducted. At least one parent was asked to participate in the family sessions. After the implementation of the intervention group was completed, the final tests of the scales used in the research were applied again to both the intervention and the control group. After the data of the study were collected, a focus group interview, one of the interview methods used in qualitative research on the effectiveness and organization of a Cognitive Behavioral Model-Based Family Counseling Program, was conducted for 5 students selected from the initiative group and the effectiveness of the program was evaluated. Receives: Behavioral: Cognitive Behavioral Model-Based Family Counseling Program |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Future Anxiety Levels
This measure assesses the change in future anxiety levels among university students participating in the Cognitive Behavioral Therapy-based Family Counseling Program. The Future Anxiety Scale for University Students will be used to quantify this change. The scale ranges from a minimum score of 19 to a maximum score of 95. Higher scores indicate an increase in the level of future anxiety.
Measured: Baseline (at study start) and at 8 weeks post-intervention.
Improvement in Mindfulness Awareness Levels
This outcome measures the enhancement in mindfulness awareness levels as determined by the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults. Changes from baseline to post-intervention will be assessed to determine the effectiveness of the intervention. The scale ranges from a minimum score of 18 to a maximum score of 90. Higher scores indicate an increase in the level of mindfulness awareness
Measured: Baseline (at study start) and at 8 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start2 Jan 2022
- Primary completion30 Nov 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted using an experimental pre-test, post-test, follow-up randomized controlled group experimental research design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Geylani, Istanbul University - Cerrahpasa
- Investigators
- merve geylani, MSc, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464211
- Sponsor's protocol ID
- MGeylani
- Acronym
- not
- Status last verified
- Jun 2024
- First submitted
- 7 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family Counseling Program Applied to University Students With Future Anxiety on Anxiety and Conscious Awareness Levels
- ClinicalTrials.gov ID
- NCT06464211
- Acronym / sponsor ID
- not / MGeylani
- Conditions
- Anxiety, Awareness, Family Therapy, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Jun 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.
This study investigates the effect of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on the anxiety and mindfulness levels of university students experiencing future anxiety. The research highlights the significance of university education in career development, noting the associated biopsychosocial challenges faced by students. These challenges often manifest as future anxiety-a condition characterized by fear, uncertainty, and stress about future prospects, which can impact students' academic performance, social relationships, and overall mental health. Literature reveals that interventions like CBT, mindfulness practices, and family counseling are effective in managing anxiety and enhancing emotional resilience. The program integrates these approaches to provide dual-layer support, addressing individual thought patterns and family dynamics, thus potentially reducing anxiety and increasing mindfulness among students. This study aims to provide a comprehensive understanding of the program's effectiveness in a controlled setting, contributing to both national and international literature on mental health interventions.
Detailed description
This research was conducted as a pre-test, post-test randomized controlled study to determine the effects of a Cognitive Behavioral Therapy (CBT)-based Family Counseling Program on anxiety and mindfulness levels in university students experiencing future anxiety. The study collected data from 20 students, divided equally between 10 participants in the intervention group and 10 in the control group. Data were gathered using a Personal Characteristics Form, the Future Anxiety Scale for University Students, and the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults.
The intervention group participated in an online CBT-based Family Counseling Program, which was conducted weekly for 8 weeks, each session lasting between 50-60 minutes. For the first 6 weeks, the sessions included only the students, while the last two weeks also involved family members' participation. No intervention was applied to the control group. Both groups were assessed with the aforementioned scales before the intervention and after its conclusion. This study aims to provide insights into the effectiveness of integrating family dynamics into therapeutic practices for reducing anxiety and enhancing mindfulness among students.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted using an experimental pre-test, post-test, follow-up randomized controlled group experimental research design
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Cognitive Behavioral Model-Based Family Counseling ProgramThere were 6 face-to-face sessions with students for 50- 60 minutes/week, and 2 sessions with internet-based video programs with students' families. Cognitive Behavioral Model-Based Family Counseling Program was conducted. At least one parent was asked to participate in the family sessions. After the implementation of the intervention group was completed, the final tests of the scales used in the research were applied again to both the intervention and the control group. After the data of the study were collected, a focus group interview, one of the interview methods used in qualitative research on the effectiveness and organization of a Cognitive Behavioral Model-Based Family Counseling Program, was conducted for 5 students selected from the initiative group and the effectiveness of the program was evaluated. |
| control group | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The level of future anxiety is above 40 points
- No problems with speech, perception or hearing
Key exclusion criteria (0 listed)
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 Model-Based Family Counseling ProgramA Cognitive Behavioral Model-Based Family Counseling Program is a therapeutic approach that focuses on identifying and changing negative thought patterns and behaviors within the family unit, using principles of cognitive-behavioral therapy to improve communication, resolve conflicts, and enhance overall family functioning. | Behavioural | experimental group |
Primary outcome
Reduction in Future Anxiety Levels
Time frame: Baseline (at study start) and at 8 weeks post-intervention.
This measure assesses the change in future anxiety levels among university students participating in the Cognitive Behavioral Therapy-based Family Counseling Program. The Future Anxiety Scale for University Students will be used to quantify this change. The scale ranges from a minimum score of 19 to a maximum score of 95. Higher scores indicate an increase in the level of future anxiety.
Improvement in Mindfulness Awareness Levels
Time frame: Baseline (at study start) and at 8 weeks post-intervention.
This outcome measures the enhancement in mindfulness awareness levels as determined by the Turkish version of the Mindfulness Awareness Scale for Adolescents and Adults. Changes from baseline to post-intervention will be assessed to determine the effectiveness of the intervention. The scale ranges from a minimum score of 18 to a maximum score of 90. Higher scores indicate an increase in the level of mindfulness awareness
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 18 Jun 2024.
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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.
merve geylani, MSc principal investigator
Istanbul University - Cerrahpasa
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 Model-Based Family Counseling Program in people with Anxiety and Awareness, run by Istanbul University - Cerrahpasa 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 0 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 18 Jun 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 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?
Reduction in Future Anxiety Levels (time frame: Baseline (at study start) and at 8 weeks post-intervention.). The study lists 2 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 18 Jun 2024.