The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students

Mental Health Issue Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344624
• Other study ID #: Mersin_U
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: Mersin University
• Contact: EMINE ÖNCÜ, Assoc.Prof.
• Phone: +905052775502
• Email: eeoncu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: February 1, 2025
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• CBT group
Brief cognitive behavioral therapy
• Laughter group
Laughter yoga therapy

Locations

Country	Name	City	State
Turkey	Turkey, Mersin University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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).
Secondary	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 a coefficient for the scale is 0.95.	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).