Mental Health IssueNCT06344624
The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students
A study testing CBT group and Laughter group in people with Mental Health Issue, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- CBT group and Laughter group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 12 Jun 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Currently enrolled in the nursing faculty between April 10, 2024, and June 2, 2024.
- Scored within the top 20% on the Brief Symptom Inventory for mental symptom scores.
- Voluntarily agree to participate in the study and have signed the Informed Consent Form.
- Understand and comprehend Turkish language
Who cannot join
- Having received cognitive behavioral therapy previously.
- Undergoing psychological or psychiatric treatment.
- Underwent surgical procedures in the last three months.
- Having chronic illnesses requiring regular medication use.
- Having glaucoma or hernia conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Brief Cognitive-behavioral Group Therapy and Laughter Yoga on Depression and Psychological Resilience in Nursing Students With Mental Symptoms: A Randomized Controlled Trial
The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms.
Read the detailed description
A randomized controlled trial with a pretest-posttest design is planned to be conducted among 114 nursing students with mental symptoms between April and June 2024. The block randomization method will be used to assign students to the Cognitive Behavioral Therapy (CBT) Group and the Laughter Group. Brief cognitive behavioral therapy (b-CBT) will be applied to one group, and laughter yoga will be applied to the other group twice a week for 3 weeks, with sessions lasting 60 minutes each. Data will be collected through the Brief Symptom Inventory, Psychological Resilience Scale, and Automatic Thoughts Scale. Measurements will be done at baseline, right after the sixth session ends, and four weeks later.
During the b-CBT process, techniques such as breath-body awareness and self-identification, coping techniques for emotional and physical symptoms of depression, recognizing the interaction between thoughts, emotions, and behaviors, cognitive restructuring to replace dysfunctional thoughts and internal dialogues with functional ones, and future planning will be employed. Laughter yoga will consist of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises.
The results obtained from the research will provide an opportunity to identify methods that may be effective in helping nurses acquire the necessary skills to improve their mental health.
- Conditions
- Mental Health Issue
- Being tested
- CBT group, Laughter group
- Keywords
- Brief cognitive-behavioral group therapy, laughter yoga, mental symptoms, nursing students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT groupBehavioural
Brief cognitive behavioral therapy
Laughter groupBehavioural
Laughter yoga therapy
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy Group | Active comparator | In the first sessions, less time was allotted to the introductory phase because it was anticipated that students would face similar issues in terms of age, gender, and academic standing, and that their depressive symptoms would be milder than those of clinical patient groups. Additionally, more intensive short-term cognitive behavioral therapy (b-CBT) was preferred. Six sessions, two per week for three weeks, lasting sixty minutes each, were planned, with four groups of eight to twelve students based on course schedules. A researcher with a doctorate in mental health nursing and certification in CBT will oversee CBT. The program aims to enhance students' mindful awareness. Key CBT techniques will include breath-body awareness, coping methods for emotional and physical depression symptoms (breathing and attention exercises), recognizing thought-emotion-behavior interactions, cognitive restructuring, and future planning. Receives: Behavioral: CBT group |
| Laughter Yoga Therapy Group | Active comparator | There will be a certified researcher leading the laughter yoga sessions. Laughter yoga will ideally allow participants to sit comfortably in front of each other's eyes. Six sessions, two per week for three weeks, lasting sixty minutes each, were planned, with four groups of eight to twelve students based on course schedules. Laughter yoga consists of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises. Receives: Behavioral: Laughter group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in mental symptoms will be assessed using the Brief Symptom Inventory.
The scale consists of 53 Likert-type items. Items are scored on a scale of 0 to 4, corresponding to "not at all" and "very much," respectively. The higher the total score obtained from the scale, the more the individual's mental symptoms increase. It comprises nine subscales, three global indices, and additional items. The subscales are somatization, obsessive-compulsive disorder, interpersonal sensitivity, depression, anxiety disorder, hostility, phobic anxiety, paranoid ideation, and psychoticism, while additional items relate to eating disorders, sleep disturbances, thoughts of death and suicide, and feelings of guilt.
Measured: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and and 4 weeks later the end of the 6th season (T2).
Secondary outcomes (2)
Psychological resilience will be assessed using the Psychological Resilience Scale.
The Psychological Resilience Scale (PRS) consists of six items that respondents self-report on a 5-point Likert scale. Higher scores correspond to higher psychological resilience levels. The scores for items 2, 4, and 6 are reversed. The response options on the Likert scale range from "not at all suitable" (1), "not suitable" (2), "somewhat suitable" (3), "suitable" (4), and "completely suitable" (5). With an internal consistency score of.83, the scale has a high Cronbach's alpha coefficient.
Measured: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and 4 weeks later the end of the 6th season (T2).
Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale.
This scale is designed to measure common thought patterns and negative self-evaluations often seen in depression. The scale is in Likert format and consists of 30 items. For each item, response options range from "never" (1), "rarely" (2), "occasionally" (3), "frequently" (4), and "always" (5). A higher score denotes a higher frequency of automatic thoughts linked to depression. The total score ranges from 30 to 150. The Cronbach's α coefficient for the scale is 0.95.
Measured: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and 4 weeks later the end of the 6th season (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start10 Apr 2024
- Primary completion2 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with a pretest-posttest design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine ÖNCÜ, Mersin University
- Investigators
- EMİNE ÖNCÜ, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344624
- Sponsor's protocol ID
- Mersin_U
- Status last verified
- Jun 2024
- First submitted
- 25 Mar 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Brief Cognitive-behavioral Group Therapy and Laughter Yoga on Depression and Psychological Resilience in Nursing Students With Mental Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06344624
- Acronym / sponsor ID
- Mersin_U
- Conditions
- Mental Health Issue
- Keywords
- Brief cognitive-behavioral group therapy, laughter yoga, mental symptoms, nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 3 Apr 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 presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms.
Detailed description
A randomized controlled trial with a pretest-posttest design is planned to be conducted among 114 nursing students with mental symptoms between April and June 2024. The block randomization method will be used to assign students to the Cognitive Behavioral Therapy (CBT) Group and the Laughter Group. Brief cognitive behavioral therapy (b-CBT) will be applied to one group, and laughter yoga will be applied to the other group twice a week for 3 weeks, with sessions lasting 60 minutes each. Data will be collected through the Brief Symptom Inventory, Psychological Resilience Scale, and Automatic Thoughts Scale. Measurements will be done at baseline, right after the sixth session ends, and four weeks later.
During the b-CBT process, techniques such as breath-body awareness and self-identification, coping techniques for emotional and physical symptoms of depression, recognizing the interaction between thoughts, emotions, and behaviors, cognitive restructuring to replace dysfunctional thoughts and internal dialogues with functional ones, and future planning will be employed. Laughter yoga will consist of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises.
The results obtained from the research will provide an opportunity to identify methods that may be effective in helping nurses acquire the necessary skills to improve their mental health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with a pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Group | Active comparator | Behavioral: CBT groupIn the first sessions, less time was allotted to the introductory phase because it was anticipated that students would face similar issues in terms of age, gender, and academic standing, and that their depressive symptoms would be milder than those of clinical patient groups. Additionally, more intensive short-term cognitive behavioral therapy (b-CBT) was preferred. Six sessions, two per week for three weeks, lasting sixty minutes each, were planned, with four groups of eight to twelve students based on course schedules. A researcher with a doctorate in mental health nursing and certification in CBT will oversee CBT. The program aims to enhance students' mindful awareness. Key CBT techniques will include breath-body awareness, coping methods for emotional and physical depression symptoms (breathing and attention exercises), recognizing thought-emotion-behavior interactions, cognitive restructuring, and future planning. |
| Laughter Yoga Therapy Group | Active comparator | Behavioral: Laughter groupThere will be a certified researcher leading the laughter yoga sessions. Laughter yoga will ideally allow participants to sit comfortably in front of each other's eyes. Six sessions, two per week for three weeks, lasting sixty minutes each, were planned, with four groups of eight to twelve students based on course schedules. Laughter yoga consists of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Currently enrolled in the nursing faculty between April 10, 2024, and June 2, 2024.
- Scored within the top 20% on the Brief Symptom Inventory for mental symptom scores.
- Voluntarily agree to participate in the study and have signed the Informed Consent Form.
- Understand and comprehend Turkish language
Key exclusion criteria (5 listed)
- Having received cognitive behavioral therapy previously.
- Undergoing psychological or psychiatric treatment.
- Underwent surgical procedures in the last three months.
- Having chronic illnesses requiring regular medication use.
- Having glaucoma or hernia conditions.
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 |
|---|---|---|
| CBT groupBrief cognitive behavioral therapy | Behavioural | Cognitive Behavioral Therapy Group |
| Laughter groupLaughter yoga therapy | Behavioural | Laughter Yoga Therapy Group |
Primary outcome
The change in mental symptoms will be assessed using the Brief Symptom Inventory.
Time frame: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and and 4 weeks later the end of the 6th season (T2).
The scale consists of 53 Likert-type items. Items are scored on a scale of 0 to 4, corresponding to "not at all" and "very much," respectively. The higher the total score obtained from the scale, the more the individual's mental symptoms increase. It comprises nine subscales, three global indices, and additional items. The subscales are somatization, obsessive-compulsive disorder, interpersonal sensitivity, depression, anxiety disorder, hostility, phobic anxiety, paranoid ideation, and psychoticism, while additional items relate to eating disorders, sleep disturbances, thoughts of death and suicide, and feelings of guilt.
2 secondary outcomes
Psychological resilience will be assessed using the Psychological Resilience Scale.
Time frame: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and 4 weeks later the end of the 6th season (T2).
Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale.
Time frame: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and 4 weeks later the end of the 6th season (T2).
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 13 Jun 2024.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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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.
EMİNE ÖNCÜ principal investigator
Mersin 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 CBT group and Laughter group in people with Mental Health Issue, run by Mersin 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 4 inclusion and 5 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 13 Jun 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 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?
The change in mental symptoms will be assessed using the Brief Symptom Inventory. (time frame: Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and and 4 weeks later the end of the 6th season (T2).). 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 13 Jun 2024.