- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06290362
Exploring Digitalized Interventions for Stress and Problem Solving
The New Age of Cyber Care: Exploring Digitalized Interventions for Stress and Problem Solving - A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İzmir, Turkey, 35100
- Ege University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be over 18 years of age,
- Being an university student,
- Volunteer for the study,
- Possess the necessary technological resources
Exclusion Criteria:
- 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%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
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Experimental: Cognitive Behavioural Theory-based group consultation
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through intervention completion, an average of 2 month
|
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.
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Through intervention completion, an average of 2 months
|
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.
|
Through intervention completion, an average of 5 month
|
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.
|
Through intervention completion, an average of 5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EgeTrial4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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