StressNCT05405699
'Digitalization in Psychoeducation' The Effect of Tele-Psychoeducation on Problem-Solving Skills and Stress
A study testing digitalized group psychoeducation in people with Stress and Problems Psychosocial, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The effect of tele-psychoeducation based on an online social media platform, which had never been done previously, on problem-solving skills and stress levels in young adults was investigated. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Problems Psychosocial
- What is being tested?
- digitalized group psychoeducation
- 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
- 5 Apr 2021to 31 Aug 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 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being adult
- Being volunteer to participation
- Must be have the required technological opportunities
Who cannot join
- To receive a professional support that can affect coping skills during the data collection process
- Not participate in 20% of tele-psychoeducational interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Digitalization in Psychoeducation' The Effect of Tele-Psychoeducation on Problem-Solving Skills and Stress: A Randomized Factorial Trial
The effect of tele-psychoeducation based on an online social media platform, which had never been done previously, on problem-solving skills and stress levels in young adults was investigated. A randomized, single-blind factorial trial was conducted with two groups of 54 university students who met the inclusion criteria. Cognitive behavioural based psychoeducation was carried on via Instagram's both online and asynchronized sessions for 8 weeks. Data were collected using pre-/posttest and follow-up measurements with the Problem-Solving Inventory and Perceived Stress Scale and were analysed using factorial analysis of variance. ηp2 and Cohen's r was used, which shows the effect size with variance distribution.
Read the detailed description
The research hypotheses are as follows:
- H1: There is a significant difference between the mean scores of the Problem Solving Inventory in favour of the 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 intervention group in the time series.
- H1: The recently developed group tele-psychoeducational intervention is effective for reducing Problem Solving Inventory mean scores.
- H1: The recently developed group tele-psychoeducational intervention is effective for reducing Perceived Stress Scale mean scores.
Research data was collected with an online survey tool (Googledocs) that does not require a usage fee or license. The tool is convenient and economical in that it is suitable for use with any electronic device that can connect to the internet. The developed online form was piloted with ten students. Arrangements were made for the clarity of the questions and the convenience of the online tool. Pilot study data was not included in the findings. The tools detailed below were used to collect the data.
Personal Data Collection Form: This form consists of 11 multiple-choice questions to determine the variables that may have an impact on the sociodemographic characteristics, health history, and problem-solving skills of the participants. The questions were prepared by the research team in the light of the literature.
Problem Solving Inventory: The Problem Solving Inventory (PSI), developed by Heppner and Petersen (1982), 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 higher total scores obtained from the scale indicate that the individual perceives himself as inadequate in terms of problem solving skills. The Cronbach alpha consistency coefficient of the original scale was .90, and the coefficients obtained for the subscales were between .72 and .85. The scale was adapted to Turkish by Şahin et al. (1993), and the Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.
Perceived Stress Scale: The scale was developed by Cohen et al. (1983), and adapted into Turkish by Eskin et al. (2013). The Perceived Stress Scale (PSS) is designed to measure how stressful situations in one's life are perceived. Five-point Likert-type scale items are interpreted over the total score and two sub-dimensions (Perception of Insufficient Self-efficacy and Perception of Stress Discomfort). 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.
Data Collection: Data collection in the study was planned in line with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES), which can be considered as a method and reporting guide for online survey research. The research's data security was ensured via a user account to which only two members of the research team had access and which would not be shared with any other user, and the access link was terminated when the data collection process was completed.
- Conditions
- Stress, Problems Psychosocial
- Being tested
- digitalized group psychoeducation
- Keywords
- Problem solving skills, psychoeducation, stress, mobile health, telepsychiatry, digitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digitalized group psychoeducationBehavioural
Problem Solving Approach based problem solving skills psychoeducation's session topics of eight weeks are as follows:
- Introduction and warm-up,
- Problem orientation-identifying the problem,
- Identifying prior problems-Which do I want to start from?
- Recognizing the losses caused by problems and complaints,
- Setting reachable and realistic goals,
- Generating alternatives -What can I do?
- Regulating emotions,
- Experimenting and exploring. The main outcomes of each session were determined, and sessions were completed in approximately one hour as a semi-structured interactive group training according to group dynamics.
Three days a week for 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. Participants were connected to the live broadcast of the research team and interacted via text messages.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: digitalized group psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem Solving Inventory (first evaluation with posttest)
The Problem Solving Inventory (PSI), developed by Heppner and Petersen (1982), 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 higher total scores obtained from the scale indicate that the individual perceives himself as inadequate in terms of problem solving skills. The Cronbach alpha consistency coefficient of the original scale was .90, and the coefficients obtained for the subscales were between .72 and .85 (Heppner \& Petersen, 1982). The scale was adapted to Turkish by Şahin et al. (1993), and the Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.
Measured: Through study completion, an average of 4 months
Perceived Stress Scale (first evaluation with posttest)
The scale was developed by Cohen et al. (1983), and adapted into Turkish by Eskin et al. (2013). The Perceived Stress Scale (PSS) is designed to measure how stressful situations in one's life are perceived. Five-point Likert-type scale items are interpreted over the total score and two sub-dimensions (Perception of Insufficient Self-efficacy and Perception of Stress Discomfort). 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 study completion, an average of 4 months
Problem Solving Inventory (second evaluation with follow up)
Measured: Through study completion, an average of 7 months
Perceived Stress Scale (second evaluation with follow up)
Measured: Through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start5 Apr 2021
- Primary completion18 Aug 2021
- Study completion31 Aug 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.
- More trials run by Ege UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study is a single-blind, randomized, factorial experimental type follow-up study with a control group.
- Masking
- None (open label)
- 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
- NCT05405699
- Sponsor's protocol ID
- EgeTrial2
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Digitalization in Psychoeducation' The Effect of Tele-Psychoeducation on Problem-Solving Skills and Stress: A Randomized Factorial Trial
- ClinicalTrials.gov ID
- NCT05405699
- Acronym / sponsor ID
- EgeTrial2
- Conditions
- Stress, Problems Psychosocial
- Keywords
- Problem solving skills, psychoeducation, stress, mobile health, telepsychiatry, digitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Jun 2022 (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 effect of tele-psychoeducation based on an online social media platform, which had never been done previously, on problem-solving skills and stress levels in young adults was investigated. A randomized, single-blind factorial trial was conducted with two groups of 54 university students who met the inclusion criteria. Cognitive behavioural based psychoeducation was carried on via Instagram's both online and asynchronized sessions for 8 weeks. Data were collected using pre-/posttest and follow-up measurements with the Problem-Solving Inventory and Perceived Stress Scale and were analysed using factorial analysis of variance. ηp2 and Cohen's r was used, which shows the effect size with variance distribution.
Detailed description
The research hypotheses are as follows:
- H1: There is a significant difference between the mean scores of the Problem Solving Inventory in favour of the 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 intervention group in the time series.
- H1: The recently developed group tele-psychoeducational intervention is effective for reducing Problem Solving Inventory mean scores.
- H1: The recently developed group tele-psychoeducational intervention is effective for reducing Perceived Stress Scale mean scores.
Research data was collected with an online survey tool (Googledocs) that does not require a usage fee or license. The tool is convenient and economical in that it is suitable for use with any electronic device that can connect to the internet. The developed online form was piloted with ten students. Arrangements were made for the clarity of the questions and the convenience of the online tool. Pilot study data was not included in the findings. The tools detailed below were used to collect the data.
Personal Data Collection Form: This form consists of 11 multiple-choice questions to determine the variables that may have an impact on the sociodemographic characteristics, health history, and problem-solving skills of the participants. The questions were prepared by the research team in the light of the literature.
Problem Solving Inventory: The Problem Solving Inventory (PSI), developed by Heppner and Petersen (1982), 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 higher total scores obtained from the scale indicate that the individual perceives himself as inadequate in terms of problem solving skills. The Cronbach alpha consistency coefficient of the original scale was .90, and the coefficients obtained for the subscales were between .72 and .85. The scale was adapted to Turkish by Şahin et al. (1993), and the Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.
Perceived Stress Scale: The scale was developed by Cohen et al. (1983), and adapted into Turkish by Eskin et al. (2013). The Perceived Stress Scale (PSS) is designed to measure how stressful situations in one's life are perceived. Five-point Likert-type scale items are interpreted over the total score and two sub-dimensions (Perception of Insufficient Self-efficacy and Perception of Stress Discomfort). 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.
Data Collection: Data collection in the study was planned in line with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES), which can be considered as a method and reporting guide for online survey research. The research's data security was ensured via a user account to which only two members of the research team had access and which would not be shared with any other user, and the access link was terminated when the data collection process was completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a single-blind, randomized, factorial experimental type follow-up study with a control group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: digitalized group psychoeducation |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being adult
- Being volunteer to participation
- Must be have the required technological opportunities
Key exclusion criteria (2 listed)
- To receive a professional support that can affect coping skills during the data collection process
- Not participate in 20% of tele-psychoeducational interventions
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 |
|---|---|---|
| digitalized group psychoeducationProblem Solving Approach based problem solving skills psychoeducation's session topics of eight weeks are as follows: 1. Introduction and warm-up, 2. Problem orientation-identifying the problem, 3. Identifying prior problems-Which do I want to start from? 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. The main outcomes of each session were determined, and sessions were completed in approximately one hour as a semi-structured interactive group training according to group dynamics. Three days a week for 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. Participants were connected to the live broadcast of the research team and interacted via text messages. | Behavioural | Intervention |
Primary outcome
Problem Solving Inventory (first evaluation with posttest)
Time frame: Through study completion, an average of 4 months
The Problem Solving Inventory (PSI), developed by Heppner and Petersen (1982), 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 higher total scores obtained from the scale indicate that the individual perceives himself as inadequate in terms of problem solving skills. The Cronbach alpha consistency coefficient of the original scale was .90, and the coefficients obtained for the subscales were between .72 and .85 (Heppner \& Petersen, 1982). The scale was adapted to Turkish by Şahin et al. (1993), and the Cronbach alpha consistency coefficient was found to be .88. In our study, the Cronbach alpha coefficient was .78.
Perceived Stress Scale (first evaluation with posttest)
Time frame: Through study completion, an average of 4 months
The scale was developed by Cohen et al. (1983), and adapted into Turkish by Eskin et al. (2013). The Perceived Stress Scale (PSS) is designed to measure how stressful situations in one's life are perceived. Five-point Likert-type scale items are interpreted over the total score and two sub-dimensions (Perception of Insufficient Self-efficacy and Perception of Stress Discomfort). 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 study completion, an average of 7 months
Perceived Stress Scale (second evaluation with follow up)
Time frame: Through study completion, an average of 7 months
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 9 Jun 2022.
- Individual participant dataSharing planned: Yes
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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 digitalized group psychoeducation in people with Stress and Problems Psychosocial, 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 3 inclusion and 2 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 9 Jun 2022. 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?
Problem Solving Inventory (first evaluation with posttest) (time frame: Through study completion, an average of 4 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 9 Jun 2022.