StressNCT06290362
Exploring Digitalized Interventions for Stress and Problem Solving
A study testing Cognitive Behavioural Theory-based group consultation in people with Stress and Problem-solving, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Problem-solving
- What is being tested?
- Cognitive Behavioural Theory-based group consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2021to 28 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 18 years of age,
- Being an university student,
- Volunteer for the study,
- Possess the necessary technological resources
Who cannot join
- Have a physical or sensory impairment that would affect the ability to use online technology (e.g., history of temporal brain damage, limb loss, hearing loss, etc.),
- Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities
- Be receiving any professional support that could potentially influence their coping skills during data collection
- This calculation was performed to ensure that the study would have an appropriate sample size to detect meaningful effects and draw reliable conclusions. In this study, an alpha level of 0.05 and a beta level of 0.20 have been set. Based on the results of previous similar studies, it has been determined that a minimum sample size of 24 (total 48) is required for each group.
- Following the completion of the announcement and registration phase, a random assignment process was conducted to allocate 54 students into either the control or intervention groups, adhering to the guidelines of the Consort Model.
- Gender, problem-solving skills, and perceived stress levels were taken into account during the group allocation process.
- The RCT\'s statistical power, calculated post hoc within a 95% confidence interval and a sampling error of d=.05, was determined to be 83.0%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The New Age of Cyber Care: Exploring Digitalized Interventions for Stress and Problem Solving - A Randomized Controlled Trial
Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and problem-solving skills among young adults.
Read the detailed description
A randomized, single-blind factorial trial with a control group was conducted. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed the Problem-Solving Inventory and Perceived Stress Scale, analyzed using factorial analysis of variance. Effect sizes were determined using ηp2 and Cohen\'s r.
Significant differences were found between groups for Problem-Solving Inventory (F(2-104):5.005)(p\<0.05). The key findings of our RCT study is the strong impact of digitalized intervention on the time-group interaction (p\<0.05). This highlights the effectiveness of the Instagram-based telehealth tool in facilitating long-lasting improvements among young adults. These findings shed light on the potential of social media platforms, like Instagram, as not only popular but successful tools for mental health interventions. Nurses can incorporate these digital interventions to enhance mental health support, reach a wider audience, and overcome barriers associated with traditional methods.
- H1: There is a significant difference between the mean scores of the Problem Solving Inventory in favour of the Instagram-based intervention group in the time series.
- H1: There is a significant difference between the mean scores of the Perceived Stress Scale in favour of the Instagram-based intervention group in the time series.
- H1: Instagram-based telehealth is effective for reducing Problem Solving Inventory scores.
- H1: Instagram-based telehealth is effective for reducing Perceived Stress Scale scores.
- Conditions
- Stress, Problem-solving
- Being tested
- Cognitive Behavioural Theory-based group consultation
- Keywords
- telemedicine, internet-based intervention, stress, problem-solving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Theory-based group consultationBehavioural
Cognitive Behavioural Theory-based group consultation was given to the intervention group through an Instagram as online social media platform. This approach has been developed with the philosophy of Cognitive Behavioral Theory (Eskin, 2009).
For three days a week over eight weeks, informative posts were shared, asynchronous testing and self-discovery activities were carried out, and a synchronous tele-psychoeducation session was held once a week. The participants were connected to the live broadcast of the research team, and they interacted via text messages. In this interaction, further suggestions related to the goals of the week were given, previous assignments were checked, homework for the next session was given, personal experiences and the needs of the participants were determined, and necessary feedback was provided. Instagram had the feature of maintaining the records of all participants\' attendance at these events.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Any intervention applied. Following the completion of the research, the need for psychosocial support among the control group participants was assessed, and it was found that none of the students in the control group required such support. |
| Cognitive Behavioural Theory-based group consultation | Experimental | Cognitive Behavioural Theory-based group consultation was given to the intervention group through an Instagram as online social media platform. This approach has been developed with the philosophy of Cognitive Behavioral Theory (Eskin, 2009). For three days a week over eight weeks of intervention conducted with synchronized psychoeducation sessions, online posts, surveys, personal sharing messages, and group interaction tools.
1. Introduction and warm-up,
2. Problem orientation-identifying the problem,
3. Identifying prior problems-Which one I want to start?
4. Recognizing the losses caused by problems and complaints,
5. Setting reachable and realistic goals,
6. Generating alternatives-What can I do?
7. Regulating emotions,
8. Experimenting and exploring. Sessions were completed in approximately one hour as semi-structured interactive group training according to group dynamics. Receives: Behavioral: Cognitive Behavioural Theory-based group consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (first evaluation with posttest)
The Perceived Stress Scale is designed to measure how stressful situations in one's life are perceived. The five-point Likert-type scale items (0-never, 4-very often) are interpreted over the total score and two sub-dimensions (insufficient self-efficacy and stress disturbance perception). A high total score indicates that the person perceives the stress he/she has been loaded with as high; it is interpreted as the methods used in coping with stress are not functional, and therefore they cannot cope with stress effectively. In our study, the Cronbach's alpha coefficient of the scale was determined as .75.
Measured: Through intervention completion, an average of 2 month
Problem Solving Inventory (first evaluation with posttest)
The Problem Solving Inventory is a Likert-type scale, scored between 1 and 6, consisting of 35 items that measure adults' self-perception of problem-solving skills. There are items that are reverse coded and excluded from scoring. The scale's Turkish adaptation study's Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.The higher total scores obtained from the scale indicate that the individual perceives himself/herself as inadequate in terms of problem-solving skills.
Measured: Through intervention completion, an average of 2 months
Perceived Stress Scale (second evaluation with follow up)
The Perceived Stress Scale is designed to measure how stressful situations in one's life are perceived. The five-point Likert-type scale items (0-never, 4-very often) are interpreted over the total score and two sub-dimensions (insufficient self-efficacy and stress disturbance perception). A high total score indicates that the person perceives the stress he/she has been loaded with as high; it is interpreted as the methods used in coping with stress are not functional, and therefore they cannot cope with stress effectively. In our study, the Cronbach's alpha coefficient of the scale was determined as .75.
Measured: Through intervention completion, an average of 5 month
Problem Solving Inventory (second evaluation with follow up)
The Problem Solving Inventory is a Likert-type scale, scored between 1 and 6, consisting of 35 items that measure adults' self-perception of problem-solving skills. There are items that are reverse coded and excluded from scoring. The scale's Turkish adaptation study's Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.The higher total scores obtained from the scale indicate that the individual perceives himself/herself as inadequate in terms of problem-solving skills.
Measured: Through intervention completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start16 Apr 2021
- Primary completion30 Jul 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The current 8-week randomized, single-blind factorial trial was conducted with a control group and one intervention group. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Beycan Ekitli, PhD., Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290362
- Sponsor's protocol ID
- EgeTrial4
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public data sharing is available for this study. beycan ekitli, gizem (2022), "Digitalization in Psychoeducation' The Effect of Tele-Psychoeducation", Mendeley Data, V1, doi: 10.17632/5g9bcjv43b.1 http://dx.doi.org/10.17632/5g9bcjv43b.1
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Age of Cyber Care: Exploring Digitalized Interventions for Stress and Problem Solving - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06290362
- Acronym / sponsor ID
- EgeTrial4
- Conditions
- Stress, Problem-solving
- Keywords
- telemedicine, internet-based intervention, stress, problem-solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 4 Mar 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.
Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and problem-solving skills among young adults.
Detailed description
A randomized, single-blind factorial trial with a control group was conducted. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed the Problem-Solving Inventory and Perceived Stress Scale, analyzed using factorial analysis of variance. Effect sizes were determined using ηp2 and Cohen\'s r.
Significant differences were found between groups for Problem-Solving Inventory (F(2-104):5.005)(p\<0.05). The key findings of our RCT study is the strong impact of digitalized intervention on the time-group interaction (p\<0.05). This highlights the effectiveness of the Instagram-based telehealth tool in facilitating long-lasting improvements among young adults. These findings shed light on the potential of social media platforms, like Instagram, as not only popular but successful tools for mental health interventions. Nurses can incorporate these digital interventions to enhance mental health support, reach a wider audience, and overcome barriers associated with traditional methods.
- H1: There is a significant difference between the mean scores of the Problem Solving Inventory in favour of the Instagram-based intervention group in the time series.
- H1: There is a significant difference between the mean scores of the Perceived Stress Scale in favour of the Instagram-based intervention group in the time series.
- H1: Instagram-based telehealth is effective for reducing Problem Solving Inventory scores.
- H1: Instagram-based telehealth is effective for reducing Perceived Stress Scale scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The current 8-week randomized, single-blind factorial trial was conducted with a control group and one intervention group. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Any intervention applied. Following the completion of the research, the need for psychosocial support among the control group participants was assessed, and it was found that none of the students in the control group required such support. |
| Cognitive Behavioural Theory-based group consultation | Experimental | Behavioral: Cognitive Behavioural Theory-based group consultationCognitive Behavioural Theory-based group consultation was given to the intervention group through an Instagram as online social media platform. This approach has been developed with the philosophy of Cognitive Behavioral Theory (Eskin, 2009). For three days a week over eight weeks of intervention conducted with synchronized psychoeducation sessions, online posts, surveys, personal sharing messages, and group interaction tools. 1. Introduction and warm-up, 2. Problem orientation-identifying the problem, 3. Identifying prior problems-Which one I want to start? 4. Recognizing the losses caused by problems and complaints, 5. Setting reachable and realistic goals, 6. Generating alternatives-What can I do? 7. Regulating emotions, 8. Experimenting and exploring. Sessions were completed in approximately one hour as semi-structured interactive group training according to group dynamics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be over 18 years of age,
- Being an university student,
- Volunteer for the study,
- Possess the necessary technological resources
Key exclusion criteria (7 listed)
- Have a physical or sensory impairment that would affect the ability to use online technology (e.g., history of temporal brain damage, limb loss, hearing loss, etc.),
- Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities
- Be receiving any professional support that could potentially influence their coping skills during data collection
- This calculation was performed to ensure that the study would have an appropriate sample size to detect meaningful effects and draw reliable conclusions. In this study, an alpha level of 0.05 and a beta level of 0.20 have been set. Based on the results of previous similar studies, it has been determined that a minimum sample size of 24 (total 48) is required for each group.
- Following the completion of the announcement and registration phase, a random assignment process was conducted to allocate 54 students into either the control or intervention groups, adhering to the guidelines of the Consort Model.
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 Behavioural Theory-based group consultationCognitive Behavioural Theory-based group consultation was given to the intervention group through an Instagram as online social media platform. This approach has been developed with the philosophy of Cognitive Behavioral Theory (Eskin, 2009). For three days a week over eight weeks, informative posts were shared, asynchronous testing and self-discovery activities were carried out, and a synchronous tele-psychoeducation session was held once a week. The participants were connected to the live broadcast of the research team, and they interacted via text messages. In this interaction, further suggestions related to the goals of the week were given, previous assignments were checked, homework for the next session was given, personal experiences and the needs of the participants were determined, and necessary feedback was provided. Instagram had the feature of maintaining the records of all participants\' attendance at these events. | Behavioural | Cognitive Behavioural Theory-based group consultation |
Primary outcome
Perceived Stress Scale (first evaluation with posttest)
Time frame: Through intervention completion, an average of 2 month
The Perceived Stress Scale is designed to measure how stressful situations in one's life are perceived. The five-point Likert-type scale items (0-never, 4-very often) are interpreted over the total score and two sub-dimensions (insufficient self-efficacy and stress disturbance perception). A high total score indicates that the person perceives the stress he/she has been loaded with as high; it is interpreted as the methods used in coping with stress are not functional, and therefore they cannot cope with stress effectively. In our study, the Cronbach's alpha coefficient of the scale was determined as .75.
Problem Solving Inventory (first evaluation with posttest)
Time frame: Through intervention completion, an average of 2 months
The Problem Solving Inventory is a Likert-type scale, scored between 1 and 6, consisting of 35 items that measure adults' self-perception of problem-solving skills. There are items that are reverse coded and excluded from scoring. The scale's Turkish adaptation study's Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.The higher total scores obtained from the scale indicate that the individual perceives himself/herself as inadequate in terms of problem-solving skills.
Perceived Stress Scale (second evaluation with follow up)
Time frame: Through intervention completion, an average of 5 month
The Perceived Stress Scale is designed to measure how stressful situations in one's life are perceived. The five-point Likert-type scale items (0-never, 4-very often) are interpreted over the total score and two sub-dimensions (insufficient self-efficacy and stress disturbance perception). A high total score indicates that the person perceives the stress he/she has been loaded with as high; it is interpreted as the methods used in coping with stress are not functional, and therefore they cannot cope with stress effectively. In our study, the Cronbach's alpha coefficient of the scale was determined as .75.
Problem Solving Inventory (second evaluation with follow up)
Time frame: Through intervention completion, an average of 5 months
The Problem Solving Inventory is a Likert-type scale, scored between 1 and 6, consisting of 35 items that measure adults' self-perception of problem-solving skills. There are items that are reverse coded and excluded from scoring. The scale's Turkish adaptation study's Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.The higher total scores obtained from the scale indicate that the individual perceives himself/herself as inadequate in terms of problem-solving skills.
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 7 Mar 2024.
- Individual participant dataSharing planned: Yes. Public data sharing is available for this study. beycan ekitli, gizem (2022), "Digitalization in Psychoeducation' The Effect of Tele-Psychoeducation", Mendeley Data, V1, doi: 10.17632/5g9bcjv43b.1 http://dx.doi.org/10.17632/5g9bcjv43b.1
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Behavioural Theory-based group consultation in people with Stress and Problem-solving, run by Ege 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 7 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 7 Mar 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?
Perceived Stress Scale (first evaluation with posttest) (time frame: Through intervention completion, an average of 2 month). 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 7 Mar 2024.