The effect of psychological interventions on mental function in the elderly
| ISRCTN | ISRCTN14524472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14524472 |
| Secondary identifying numbers | 2603869 |
- Submission date
- 08/08/2020
- Registration date
- 12/08/2020
- Last edited
- 12/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The world population is ageing and one of the consequences of ageing is cognitive decline (decreases in memory, attentional ability, processing speed, problem solving and planning). A decrease in these cognitive abilities can lead to poorer quality of life in elderly, losing social connections, struggling in day to day life challenges and etc. To address these issues many interventions in recent years are presented both for public use and use in professional settings. We are planning to compare three interventions in this study and see which one has the best effect on the cognition of the elderly and has the most lasting effect. The interventions that we are going to investigate are Loving Kindness Mediation (LKM; a type of mindfulness), Computerized Cognitive Training (CCT; also known as brain fitness) and Multiple Exemplar Training (MET; based on Relational Frame Theory, which is a theory to explain how human language and thought process works).
Who can participate?
Retired elderly aged between 65 and 75 years.
What does the study involve?
Participants must pass the screening The Addenbrooke’s Cognitive Examination-III (ACE-III). Participants are randomly allocated to four groups. Three of them are experimental groups (LKM, CCT and MET) and one control group with no treatment. They will be tested for cognitive baseline. The CCT and MET experimental groups will be given a specific software for training which they can use in the home and the LKM group training given a script and audio file of Loving-kindness meditation that they must practice at home. After 8 weeks of training, the participants are asked to be tested for cognitive changes as the post-test. They will be tested after another six months for follow up results to check if there is any changes from post-test cognitive results.
What are the possible benefits and risks of participating?
All the participants in experimental groups will benefit from training and once the experiment is done the control group and the experimental group will receive the most effective intervention. and there are no side effects or risk reported for the interventions of this study.
Where is the study run from?
Kharazmi University of Tehran (Iran)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Amir Etemadi
Etemadi.a.sh@gmail.com
Contact information
Scientific
Dept of clinical psychology
Faculty of Psychology
Kharazmi University of Tehran
Tehran
1418664114
Iran
 ORCID ID |
0000-0001-6143-9680 |
|---|---|
| Phone | +98 (21) 88329220-3 |
| etemadi.a.sh@gmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparing the efficacy of multiple exemplar training, cognitive training & loving-kindness meditation on enhancing the executive functions and psychological wellbeing of elderly |
| Study acronym | MET LKM CCT elderly |
| Study hypothesis | As the world's population ages, the number of people suffering from cognitive decline and dementia is increasing. One of the most important consequences of aging is cognitive decline. This growing age group emphasizes the need for fast, effective, and low-cost solutions to reduce age-related cognitive decline. in this study we aim to compare the three interventions on elderly groups and compare the results both after the treatment and after six month as follow up study. |
| Ethics approval(s) | Approved 12/01/2020, Kharazmi University Research Ethics Committee (Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran; +98-21-81455618; ethics@behdasht.gov.ir), ref: IR.KHU.REC.1398.043 |
| Condition | Cognitive decline |
| Intervention | There will be three intervention groups and one control group. CCT: One of the tools to address cognitive decline is cognitive training. This intervention typically relies on activating and stimulating brain neural circuits. Neuroplasticity is achieved during repetitive exercises that allow participants to perform cognitive operations that are slightly above their current ability threshold. Numerous studies support its use in age-related cognitive decline. the computerized version of cognitive training will be used, The CCT protocol will be provided to the subjects as interactive software and will be presented in 16 sessions over 2 months. In this software, a set of cognitive games is presented to the individual and the subject should practice them in each session for 30 - 45 minutes. these exercises are feedback based and the subject's answers and times are recorded. LKM: the second intervention that we are planing to investigate is LKM. Mindfulness is defined as the awareness of the moment to moment and without judgment of what we are experiencing internally or externally. Among all the different types of meditation, the most studied meditations are focused-attention meditation (FAM), open-monitoring meditation (OMM), and loving-kindness meditation (LKM). Love-kindness-kindness meditation includes elements from both FAM and OMM meditation. Loving-Kindness is a form of meditation that involves benevolence, along with the repetition of the phrase such as: "I wish all beings to be happy" to cultivate a sense of selfless love. The LKM experimental group will be given complete information about mindfulness and how to do it, and there will be instructions for performing love-kindness-kindness meditation both in script and audio file. This type of meditation involves the repetition of a set of phrases that are addressed first to the individual, then to others and acquaintances, and finally to all human beings and beings. For example, when meditating on oneself, one repeats phrases such as, "I wish I was safe from all dangers, I wish I was happy and at peace, and I wish I was free from suffering." This set of phrases is done in a 20-minute session consisting of the following sections: 4 minutes of self-directed phrases, phrases for a friend for about 5 minutes, for a family member for 5 minutes, and finally for all humans and living things for 6 minutes. MET: Another intervention that will be investigated in this research is Multiple Exemplar Training (MET). Multiple exemplar training (MET) is the process of teaching specific behavioral responses by exposing the organism to different stimuli in different contexts to control stimulus responses and modify behavior. In addition to shaping day to day events, the MET protocol has also found useful in shaping communication skills. MET is based on relational frame theory (RFT). The MET protocol is interactive software that is designed in 16 stages and five levels and the subject is asked to practice in 16 sessions of 30 - 45 minutes for eight weeks. After registering in the software and entering the required information, the individual enters the page where the stages are located. At the beginning of each stage, instructions are shown to the individual according to which he should perform the exercises of that stage. Control group: no treatment (waiting list) unique ID will be assigned to each participant and using the PASS software, subjects will be randomly assigned to three experimental and one control groups. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Attention is measured using Stroop test at baseline, 2 months and 8 month 2. Problem solving is measured using Tower of Hanoi at baseline, 2 months and 8 month 3. Working memory is measured using The digit span backward test, 2 months and 8 month 4. Processing speed is measured using Digit symbol substitution test, 2 months and 8 month 5. Cognitive flexibility is measured using Trail Making Test, 2 months and 8 month |
| Secondary outcome measures | Psychological well-being measured using Ryff Scales of Psychological Well-Being at month 8 |
| Overall study start date | 04/07/2017 |
| Overall study end date | 04/02/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 100 (25 in each group) |
| Participant inclusion criteria | 1. Age 65 - 75 years 2. Living in Tehran 3. Having at least a high school degree 4. Vital |
| Participant exclusion criteria | 1. Using drugs or other cognitive enhancement meth 2. Suffering from psychological disorders 3. Cognitive impairment 4. Serious health condition 5. Alcohol and drug abuse |
| Recruitment start date | 20/05/2019 |
| Recruitment end date | 04/02/2020 |
Locations
Countries of recruitment
- Iran
Study participating centre
Tehran
1418664114
Iran
Sponsor information
University/education
Tehran
Tehran
1418664114
Iran
| Phone | +98 (21) 88329220-3 |
|---|---|
| international@khu.ac.ir | |
| Website | http://khu.ac.ir/portal/faces/public/portal |
"ROR" |
https://ror.org/05hsgex59 |
Funders
Funder type
University/education
Government organisation / Local government
- Location
- Iran
Results and Publications
| Intention to publish date | 30/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets gathered and analysed during the current study will be stored in a publicly available repository (www.osf.io, SPSS data will be shared in this domain after publishing the article. the data will be available for every researcher for research purposes. the data are anonymous and there's no mention to personal data of the participants. |
Editorial Notes
12/08/2020: Trial’s existence confirmed by Kharazmi University
