NCT06290362

Brief 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 problem-solving skills among young adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

February 26, 2024

Last Update Submit

March 5, 2024

Conditions

Keywords

telemedicineinternet-based interventionstressproblem-solving

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Through intervention completion, an average of 5 months

Study Arms (2)

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.

Behavioral: Cognitive Behavioural Theory-based group consultation

Interventions

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.

Cognitive Behavioural Theory-based group consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be over 18 years of age,
  • Being an university student,
  • Volunteer for the study,
  • Possess the necessary technological resources

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Dr.

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

April 16, 2021

Primary Completion

July 30, 2021

Study Completion

November 28, 2021

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
By publication with no end date.
Access Criteria
It is planned to publish the research results in a high-impact journal in the field.
More information

Locations