Investigating the effect of implementing a training package based on cognitive behavioral therapy on sleep quality and mental health of elderly men living in nursing homes

Investigating the effect of implementing an educational package based on cognitive behavioral therapy on sleep quality and mental health of elderly men living in nursing homes

This is a double-blind clinical trial with the available sampling method, among 68 elderly men living in nursing homes, will be randomly divided into an intervention group (34 people) and a control group (34 people) with 4 permutation blocks.

Before the start of the intervention, both groups will be pre-tested using the PSQ and GHQ. The intervention group has 8 sessions of 45 minutes in 8 weeks, as a group in the form of questions and answers, lectures, pamphlets and educational animations in the form of a storyline and presentation of homework based on the treatment plan of Colin Espy, and the control group will not receive special treatment. The completion of the questionnaires (before the intervention, at the end of the intervention and one month after the end of the study) will be done by the secretary, who after completing the questionnaires, the secretary will enter the data into SPSS 26 software, and the statistical analysis will be done by the statistical consultant who won't know allocation and intervention.

Inclusion criteria: age 65 years and older, having minimum reading and writing literacy, not participating in a similar training course, obtaining a score of 24 or higher in MMSE, willingness to participate in research Exclusion criteria: use of sleeping pills, smoking, absence of more than two sessions

Intervention group: 8 sessions of 45 minutes in 8 weeks, in group discussion, lectures, pamphlets and animations in the form of a storyline with assignments based on Colin Espy's plan. Control group: they will receive usual daily care and verbal communication.

Sleep quality, mental health

The present study is a double-blind clinical trial with a pre-test, post-test and follow-up with a control group, which is available as a sampling from among the elderly men aged 65 and older living in Kermanshah nursing home who consent to participate in the study and are eligible. The conditions and criteria for entering the study are, in the form of a permutation block of 4 people, 68 of these people were randomly assigned to 2 intervention groups receiving an educational package based on cognitive behavioral therapy (34 people) and control (34 people), with the aim of investigating the effect of the package Training based on cognitive behavioral therapy on sleep quality and mental health of elderly men living in Kermanshah nursing home will be conducted in 1403. After receiving the code of ethics and registration in the clinical trial center of Iran and a written permission from the research vice-chancellor of Ilam University of Medical Sciences, first go to the general welfare department of Kermanshah city and after going through the legal procedures, considering the ethical principles of the research and introducing them to the relevant nursing home. A written informed consent will be obtained from the elderly referring to the nursing home who are willing to participate in the study and who meet the criteria for entering the study, and after being divided into intervention and control groups, a pre-test will be conducted using a quality questionnaire. Pittsburgh Sleep and Goldberg Public Health will be completed by the secretary. The method of assigning people to the intervention and control groups will be as follows: 1) PPCC 2) PCPC 3) PCCP 4) CCPP 5) CPCP and 6) CPPC will be written on 6 separate sheets, where the letter P means Practice (educational package based on cognitive behavioral therapy) and the letter C means Control (without intervention). We will put 6 sheets in 6 separate envelopes. In the target nursing home, there are 4 buildings, buildings number 1 and 2 will be considered as one block and buildings number 3 and 4 will be considered as one block, and by throwing a coin, it will be determined whether they are intervention or control, then by referring to each The elderly person will be given an envelope to the nursing home center if they meet the entry criteria and personal satisfaction, based on the 4 permutation block randomization method, which contains the desired sequences, and after the sequence appears, if the letter P is displayed (educational package based on cognitive behavioral therapy) he is given a container containing two balls with the numbers of the intervention building (after determining the intervention building) to randomly choose one and enter one of the intervention buildings, and if the letter C (control) is displayed He is given a container containing two balls with the numbers of the control building, so that he randomly chooses one and enters one of the control buildings, which will determine the status of the next 3 people besides himself, and the next 3 people will be given only the container containing the balls. will be given and the next envelope will be opened by the fifth person. The above process will continue until the desired sample volume is reached. To hide the created sequence, envelopes will be embedded that will be completely similar to each other. This method will continue until the end of allocating samples.

Blinding in this study is a double-blind type that is implemented at several levels. Those responsible for data collection and data analysis in this study are not aware of the nature of the groups; In this way, a secretary will be hired to collect data through questionnaires, and this secretary will not know the type of intervention or its duration, nor will he know about the nature of the groups and how the participants will be assigned to the groups. The same secretary responsible for data collection also enters the collected data into SPSS software. The statistical consultant analyzing the data will be blinded to the nature of the allocation of participants to groups and the type of intervention.

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