Social IsolationNCT07820020
Effectiveness of a Psychological Intervention to Reduce Social Isolation and Promote Social Connectedness in Young Adults
A study testing Digital-Assisted Group Social Skills Training in people with Social Isolation and Loneliness, run by Korea University.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of a psychological intervention aimed at reducing social isolation and promoting social connectedness among young adults. Read more about this study
- Who is it for?
- Ages 19 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Loneliness, Social Skills
- What is being tested?
- Digital-Assisted Group Social Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 19 to 34 years
- South Korean nationality
- Interpersonal Competence Questionnaire, 15-item short form (ICQ-15): mean score of 2.87 or lower
- Meets either (a) or (b) below:
- (a) Lubben Social Network Scale-6 (LSNS-6) total score of less than 12, AND short-form UCLA Loneliness Scale-8 total score of 17 or higher
- (b) Korea University Social Isolation Scale (KUSIS) total score of 9 or higher
- Confirmation on a non-face-to-face screening interview that the participant's primary difficulty involves interpersonal problems stemming from a lack of social knowledge and skills
Who cannot join
- Psychiatric or neurological hospitalization within the past 6 months
- Current or past diagnosis of a severe neurological disorder
- Cognitive impairment severe enough to hinder the basic communication required for program participation
- Suicide attempt within the past 6 months
- Severe suicide risk identified during the assessment
- History of psychotic symptoms or manic episodes
Show all 10Show fewer
- Severe psychiatric condition or major medical abnormality that would complicate participation
- Unable or unwilling to follow the research team's instructions during the application process
- Currently participating in individual or group psychotherapy that provides training in other social skills
- Participation within the past 5 years in a study on social isolation conducted by an investigator of the present research team, which raises concern for a confounding effect on the study results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this randomized controlled trial is to evaluate the effectiveness of a psychological intervention aimed at reducing social isolation and promoting social connectedness among young adults. Specifically, the study investigates the impact of an 8-week, digitally assisted face-to-face group social skills training program on individuals aged 19 to 34 who experience difficulties in interpersonal relationships and social isolation. Participants will be randomly assigned to either the active intervention group or a waitlist control group. The study aims to determine whether this structured psychosocial intervention improves interpersonal competence and social performance, reduces social isolation, and improves other psychosocial variables. Outcomes will be evaluated at three time points-pre-intervention, post-intervention, and a 1-month follow-up-utilizing a combination of self-report questionnaires and performance-based role-play assessments.
- Conditions
- Social Isolation, Loneliness, Social Skills
- Being tested
- Digital-Assisted Group Social Skills Training
- Medical subject headings
- Social Isolation, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-Assisted Group Social Skills TrainingBehavioural
Participants assigned to the active intervention arm receive an 8-week, face-to-face group social skills training program, which involves weekly 120-minute sessions supplemented by a web-based digital platform designed to promote between-session practice and skill generalization.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | No intervention | Not described |
| Digital-Assisted Group Social Skills Training | Experimental | Not described Receives: Behavioral: Digital-Assisted Group Social Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean Version of the Interpersonal Competence Questionnaire (K-ICQ)
The Korean Version of the Interpersonal Competence Questionnaire (K-ICQ) is a 31-item self-report measure of interpersonal competence. Each item is rated on a 5-point Likert scale from 1 (poor) to 5 (extremely good). The total score sums all items and ranges from 31 to 155. Higher scores indicate greater interpersonal competence, which is a better outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Social Skills Knowledge Test
The Social Skills Knowledge Test is an investigator-developed knowledge test created to objectively measure acquisition of the social skills content taught in the intervention. It consists of 21 items (multiple-choice and true/false) covering seven domains that correspond to the session curriculum: relationship formation skills, conversation skills I, conversation skills II, assertion skills, conflict management skills, dating skills, and workplace skills, with 3 items per domain. Each item has an unambiguously correct answer and is scored 1 (correct) or 0 (incorrect). The total score is the sum of correct responses and ranges from 0 to 21. Higher scores indicate greater knowledge of social skills, which is a better outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Korea University Social Isolation Scale (KUSIS)
The Korea University Social Isolation Scale (KUSIS) is a 9-item self-report measure of social isolation risk. Respondents rate their state over the past month, excluding people they currently live with. Each item is rated on a 4-point scale from 0 (never) to 3 (very much). The total score sums all items and ranges from 0 to 27, with a cut-off of 9 or higher indicating risk of social isolation. Higher scores indicate greater social isolation, which is a worse outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Secondary outcomes (8)
Lubben Social Network Scale-6 (LSNS-6)
The Lubben Social Network Scale-6 (LSNS-6) is a 6-item self-report measure of social network size and engagement; three items concern family and relatives, and three concern friends and other acquaintances. Each item is rated on a 6-point scale from 0 (none) to 5 (nine or more people). The total score sums all items and ranges from 0 to 30. Higher scores indicate a larger and more engaged social network, which is a better outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Short-form UCLA Loneliness Scale-8
The short-form UCLA Loneliness Scale-8 (ULS-8) is an 8-item self-report measure of loneliness abbreviated from the 20-item UCLA Loneliness Scale. Each item is rated on a 4-point scale from 1 (never) to 4 (always); two positively worded items are reverse-scored. The total score is the sum of all items and ranges from 8 to 32. Higher scores indicate greater loneliness, which is a worse outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms over the preceding two weeks, based on the DSM-IV diagnostic criteria for major depressive disorder. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of all items and ranges from 0 to 27. Higher scores indicate more severe depressive symptoms, which is a worse outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of the core symptoms of generalized anxiety disorder over the preceding two weeks. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of all items and ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms, which is a worse outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Korean version of the Social Interaction Anxiety Scale-Social Phobia Scale Short Form (K-SIAS-SPS-SF)
The Korean version of the Social Interaction Anxiety Scale-Social Phobia Scale Short Form (K-SIAS-SPS-SF) is a single 14-item self-report measure of social anxiety. Its items were derived by exploratory factor analysis of the pooled 40-item set of the Social Interaction Anxiety Scale and the Social Phobia Scale, and the resulting instrument is administered and scored as one scale comprising three correlated factors: social interaction anxiety (5 items), fear of overt evaluation (6 items), and fear of attracting attention (3 items). Each item is rated on a 5-point scale from 0 (not at all characteristic of me) to 4 (extremely characteristic of me). A single total score is obtained by summing all 14 items and ranges from 0 to 56, with a total score of 22 or higher indicating probable social anxiety disorder. Higher scores indicate greater social anxiety, which is a worse outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Mental Health Continuum-Short Form (MHC-SF)
The Mental Health Continuum-Short Form (MHC-SF) is a 14-item self-report measure of positive mental health over the past month, comprising three subscales: emotional well-being (3 items), social well-being (5 items), and psychological well-being (6 items). Each item is rated on a 6-point frequency scale from 0 (never) to 5 (every day). The total score sums all items and ranges from 0 to 70. Higher scores indicate greater well-being, which is a better outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report measure of perceived social support from three sources: significant other, family, and friends, with 4 items per source. Each item is rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). The total score sums all items and ranges from 12 to 84. Higher scores indicate greater perceived social support, which is a better outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Broad Autism Phenotype Questionnaire Short Form (BAPQ-SF)
The Broad Autism Phenotype Questionnaire Short Form (BAPQ-SF) is a 14-item self-report measure that assesses core features of the autism spectrum as a continuous dimension in the general population. Each item is rated on a 6-point frequency scale from 1 (very rarely) to 6 (very often), and positively worded items are reverse-scored so that higher values reflect more pronounced traits. The total score sums all items and ranges from 14 to 84. Higher scores indicate more pronounced broad autism phenotype traits, which is a worse outcome.
Measured: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KEE-HONG CHOI, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820020
- Sponsor's protocol ID
- KUIRB-2026-0388
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Psychological Intervention to Reduce Social Isolation and Promote Social Connectedness in Young Adults
- ClinicalTrials.gov ID
- NCT07820020
- Acronym / sponsor ID
- KUIRB-2026-0388
- Conditions
- Social Isolation, Loneliness, Social Skills
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2026 (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 purpose of this randomized controlled trial is to evaluate the effectiveness of a psychological intervention aimed at reducing social isolation and promoting social connectedness among young adults. Specifically, the study investigates the impact of an 8-week, digitally assisted face-to-face group social skills training program on individuals aged 19 to 34 who experience difficulties in interpersonal relationships and social isolation. Participants will be randomly assigned to either the active intervention group or a waitlist control group. The study aims to determine whether this structured psychosocial intervention improves interpersonal competence and social performance, reduces social isolation, and improves other psychosocial variables. Outcomes will be evaluated at three time points-pre-intervention, post-intervention, and a 1-month follow-up-utilizing a combination of self-report questionnaires and performance-based role-play assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | – |
| Digital-Assisted Group Social Skills Training | Experimental | Behavioral: Digital-Assisted Group Social Skills Training |
Who may qualify
- Ages
- 19 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 19 to 34 years
- South Korean nationality
- Interpersonal Competence Questionnaire, 15-item short form (ICQ-15): mean score of 2.87 or lower
- Meets either (a) or (b) below:
- (a) Lubben Social Network Scale-6 (LSNS-6) total score of less than 12, AND short-form UCLA Loneliness Scale-8 total score of 17 or higher
Key exclusion criteria (10 listed)
- Psychiatric or neurological hospitalization within the past 6 months
- Current or past diagnosis of a severe neurological disorder
- Cognitive impairment severe enough to hinder the basic communication required for program participation
- Suicide attempt within the past 6 months
- Severe suicide risk identified during the assessment
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 |
|---|---|---|
| Digital-Assisted Group Social Skills TrainingParticipants assigned to the active intervention arm receive an 8-week, face-to-face group social skills training program, which involves weekly 120-minute sessions supplemented by a web-based digital platform designed to promote between-session practice and skill generalization. | Behavioural | Digital-Assisted Group Social Skills Training |
Primary outcome
Korean Version of the Interpersonal Competence Questionnaire (K-ICQ)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
The Korean Version of the Interpersonal Competence Questionnaire (K-ICQ) is a 31-item self-report measure of interpersonal competence. Each item is rated on a 5-point Likert scale from 1 (poor) to 5 (extremely good). The total score sums all items and ranges from 31 to 155. Higher scores indicate greater interpersonal competence, which is a better outcome.
Social Skills Knowledge Test
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
The Social Skills Knowledge Test is an investigator-developed knowledge test created to objectively measure acquisition of the social skills content taught in the intervention. It consists of 21 items (multiple-choice and true/false) covering seven domains that correspond to the session curriculum: relationship formation skills, conversation skills I, conversation skills II, assertion skills, conflict management skills, dating skills, and workplace skills, with 3 items per domain. Each item has an unambiguously correct answer and is scored 1 (correct) or 0 (incorrect). The total score is the sum of correct responses and ranges from 0 to 21. Higher scores indicate greater knowledge of social skills, which is a better outcome.
Korea University Social Isolation Scale (KUSIS)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
The Korea University Social Isolation Scale (KUSIS) is a 9-item self-report measure of social isolation risk. Respondents rate their state over the past month, excluding people they currently live with. Each item is rated on a 4-point scale from 0 (never) to 3 (very much). The total score sums all items and ranges from 0 to 27, with a cut-off of 9 or higher indicating risk of social isolation. Higher scores indicate greater social isolation, which is a worse outcome.
8 secondary outcomes
Lubben Social Network Scale-6 (LSNS-6)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Short-form UCLA Loneliness Scale-8
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Korean version of the Social Interaction Anxiety Scale-Social Phobia Scale Short Form (K-SIAS-SPS-SF)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Mental Health Continuum-Short Form (MHC-SF)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Broad Autism Phenotype Questionnaire Short Form (BAPQ-SF)
Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital-Assisted Group Social Skills Training in people with Social Isolation and Loneliness, run by Korea University.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaehee Jung (821073177521, emqhfkwogml13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean Version of the Interpersonal Competence Questionnaire (K-ICQ) (time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)). The study lists 3 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 24 Sep 2026.