Psychological DistressNCT06510478
Efficacy of Group Life Skill Intervention to Enhance Well-Being Among Higher Education Students
A study testing Group Life Skill Intervention in people with Psychological Distress and Mental Health Issue, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Mental Health Issue, Quality of Life
- What is being tested?
- Group Life Skill Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 31 May 2024
- 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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students of public sector university of Pakistan.
- Students aged 21-30.
- Students accessed with decreased psychological well-being.
Who cannot join
- Students of private universities in Pakistan
- Students with any physical disability.
- Students having a prior history of psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.
Read the detailed description
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.
Study Tasks:
Participants, who are University Students aged 21-30 years, were asked to provide informed consent to participate in the study. They completed questionnaires to assess their Life skills, Psychological distress, Well-being, and Quality of life as a pre-assessment.
Participants in the intervention group undergo the Life Skill Intervention, which includes activities like Team building skills, Leadership Skills, Self-respect and appreciation, Effective Communication Skills, Dealing with stress, Positive Thinking, Enhancing confidence, Volunteering, Decision Taking, Problem Solving, Conflict Resolution, Negotiating.
After the intervention, participants completed a post-assessment questionnaires to measure changes in Life skills, Psychological distress, Well-being, and Quality of life.
There will be a control group that does not receive any treatment.
Comparison Group:
Researchers compared the outcomes between the intervention group, who received the Life Skill Intervention and the control group, who did not receive any treatment. This will help us determine if the intervention had a significant impact on Life skills, Psychological distress, Well-being, and Quality of life outcomes for University students.
- Being tested
- Group Life Skill Intervention, Treatment as Usual for Control Group
- Keywords
- Efficacy, Group Life Skill Intervention, Psychological Distress, Life skills, Quality of Life, Well being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Life Skill InterventionBehavioural
This 13-session life skills program covers essential topics in one-hour sessions. It starts with introductions and team building, then progresses through leadership, self-esteem, communication, stress management, positive thinking, confidence building, volunteering, decision-making, problem-solving, conflict resolution, and negotiation. Each session includes ice-breakers, discussions, and targeted exercises. Each session incorporates ice-breakers, open discussions, and targeted exercises to ensure active learning and skill internalization. Duration of each session was 1 hour.
Treatment as Usual for Control GroupBehavioural
Standard psychological interventions i.e. Debreathing, Meditation, supportive counseling, or psychoeducation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Who receives intervention. Life Skill intervention will be administered in 12 sessions. Receives: Behavioral: Group Life Skill Intervention |
| Control Group | Placebo comparator | Who do not receive any intervention. Receives: Behavioral: Treatment as Usual for Control Group |
| Waitlist Control Group | Active comparator | Who are on the waitlist and will receive intervention components if the intervention is proven to be effective. Receives: Behavioral: Group Life Skill Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well Being
14-item scale 'Warwick-Edinburgh Mental Well-being Scale' used to measure. Minimum score on this scale is 0 and maximum score is 30.Higher score would indicate higher level of well being.
Measured: 2 Months
Secondary outcomes (2)
Life Skills
14-item scale- Life skills questionnaire used to measure. The minimum score on this scale is 14 and the maximum score is 70. Scoring higher on this scale indicates higher life skills in individuals.
Measured: 2 Months
Psychological Distress
Depression, Anxiety, and Stress Scale used to measure. The minimum score on this scale is 0 and the maximum score is 63. Higher scores on all subscales indicate a higher level of psychological distress.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Feb 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Mushtaq, Fatima Jinnah Women University
- Investigators
- Kiran Mushtaq, PhD Scholar, Principal investigator, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510478
- Sponsor's protocol ID
- FJWU/EC/2023/66
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Group Life Skill Intervention to Enhance Well-Being Among Higher Education Students
- ClinicalTrials.gov ID
- NCT06510478
- Acronym / sponsor ID
- FJWU/EC/2023/66
- Keywords
- Efficacy, Group Life Skill Intervention, Psychological Distress, Life skills, Quality of Life, Well being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 19 Jul 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.
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.
Detailed description
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.
Study Tasks:
Participants, who are University Students aged 21-30 years, were asked to provide informed consent to participate in the study. They completed questionnaires to assess their Life skills, Psychological distress, Well-being, and Quality of life as a pre-assessment.
Participants in the intervention group undergo the Life Skill Intervention, which includes activities like Team building skills, Leadership Skills, Self-respect and appreciation, Effective Communication Skills, Dealing with stress, Positive Thinking, Enhancing confidence, Volunteering, Decision Taking, Problem Solving, Conflict Resolution, Negotiating.
After the intervention, participants completed a post-assessment questionnaires to measure changes in Life skills, Psychological distress, Well-being, and Quality of life.
There will be a control group that does not receive any treatment.
Comparison Group:
Researchers compared the outcomes between the intervention group, who received the Life Skill Intervention and the control group, who did not receive any treatment. This will help us determine if the intervention had a significant impact on Life skills, Psychological distress, Well-being, and Quality of life outcomes for University students.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Group Life Skill InterventionWho receives intervention. Life Skill intervention will be administered in 12 sessions. |
| Control Group | Placebo comparator | Behavioral: Treatment as Usual for Control GroupWho do not receive any intervention. |
| Waitlist Control Group | Active comparator | Behavioral: Group Life Skill InterventionWho are on the waitlist and will receive intervention components if the intervention is proven to be effective. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Students of public sector university of Pakistan.
- Students aged 21-30.
- Students accessed with decreased psychological well-being.
Key exclusion criteria (3 listed)
- Students of private universities in Pakistan
- Students with any physical disability.
- Students having a prior history of psychiatric illness.
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 |
|---|---|---|
| Group Life Skill InterventionThis 13-session life skills program covers essential topics in one-hour sessions. It starts with introductions and team building, then progresses through leadership, self-esteem, communication, stress management, positive thinking, confidence building, volunteering, decision-making, problem-solving, conflict resolution, and negotiation. Each session includes ice-breakers, discussions, and targeted exercises. Each session incorporates ice-breakers, open discussions, and targeted exercises to ensure active learning and skill internalization. Duration of each session was 1 hour. | Behavioural | Intervention Group, Waitlist Control Group |
| Treatment as Usual for Control GroupStandard psychological interventions i.e. Debreathing, Meditation, supportive counseling, or psychoeducation. | Behavioural | Control Group |
Primary outcome
Well Being
Time frame: 2 Months
14-item scale 'Warwick-Edinburgh Mental Well-being Scale' used to measure. Minimum score on this scale is 0 and maximum score is 30.Higher score would indicate higher level of well being.
2 secondary outcomes
Life Skills
Time frame: 2 Months
Psychological Distress
Time frame: 2 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 19 Jul 2024.
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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.
Kiran Mushtaq, PhD Scholar principal investigator
Fatima Jinnah Women University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Life Skill Intervention in people with Psychological Distress and Mental Health Issue, run by Fatima Jinnah Women University at 1 site in Pakistan.
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 3 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 19 Jul 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Well Being (time frame: 2 Months). 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 19 Jul 2024.