- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06344624
The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students
Comparing Brief Cognitive-behavioral Group Therapy and Laughter Yoga on Depression and Psychological Resilience in Nursing Students With Mental Symptoms: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: EMİNE ÖNCÜ, Assoc.Prof.
- Phone Number: +905052775502
- Email: eeoncu@gmail.com
Study Locations
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Mersin, Turkey, 33180
- Turkey, Mersin University
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Contact:
- EMİNE ÖNCÜ, Assoc.Prof.
- Email: eeoncu@gmail.com
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Sub-Investigator:
- Zeliha Yaman, Doctorate
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Sub-Investigator:
- Filiz Değirmenci, Doctorate
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cognitive Behavioral Therapy Group
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.
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Brief cognitive behavioral therapy
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Active Comparator: Laughter Yoga Therapy Group
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.
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Laughter yoga therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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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.
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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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.
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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).
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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).
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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.
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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).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: EMİNE ÖNCÜ, Mersin University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Mersin_U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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