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Cognitive DeclineNCT05016336

Cognitive Training and Social Interaction Effects on Cognitive Performance of Older Adults

A study testing Social interaction combined with cognitive training based on mnemonic strategies. and Social interaction group in people with Cognitive Decline, run by Bar-Ilan University, Israel at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aging is associated with a decline in almost all aspects of cognitive functions, particularly memory. Recent research suggests that combining cognitive training with ongoing social interaction may aid in improving cognitive functioning for older adults. Read more about this study

Who is it for?
Ages 64 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Decline
What is being tested?
Social interaction combined with cognitive training based on mnemonic strategies. and Social interaction group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteIsrael
Study dates
18 Nov 2018to 24 Feb 2019
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 64 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy participants who are active in a designated group in the community.

Who cannot join

  • Any diagnosis of cognitive decline.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Bar Ilan University

    Ramat Gan, 5290002

Other trials in Israel

About this study

Official title: Strategy Based Cognitive Training Effects on Cognitive Performance of Older Adults in a Socially Interactive Learning Group

Aging is associated with a decline in almost all aspects of cognitive functions, particularly memory. Recent research suggests that combining cognitive training with ongoing social interaction may aid in improving cognitive functioning for older adults. Furthermore, accumulative evidence suggests that strategy-based cognitive training may also improve the trainee's memory. In this study, the investigators examined the effects of a combined strategy-based cognitive training and a socially interactive learning method on cognitive performance and transfer effects in older adults.

Read the detailed description

A major concern with the aging of the world's population is a higher prevalence of age-related impairment of cognitive functions. This concern highlights the need to identify quick and effective interventions that can preserve cognitive functions.

A growing body of literature supports the notion that cognitive training may assist in promoting healthy brain aging and improve a wide range of cognitive abilities.

Cognitive training refers to a protocol consisting of a set of exercises designed to improve performance in one or several cognitive abilities. One approach to cognitive training mentioned in the literature is strategy training. Strategy training usually focuses on teaching specific strategies designed to help encode or retrieve information and involves techniques such as rehearsal, chunking, mental imagery, and story-formation.

A possible means for improving cognitive training outcomes is employing a socially interactive group-based cognitive training program versus an individual one. An abundance of studies has shown that social interaction may contribute to the slowing down of cognitive decline in old age.

Recent studies suggest that social interaction alone may not be beneficial for enhancing cognitive abilities, but when combined with a mental stimulus that requires cognitive effort, such improvement might be achieved.

Only a few studies to date have investigated the advantage of strategy training performed in-group vs individually and even fewer studies focused specifically on socially interactive learning methods. A recent pilot study combined cognitive training with social interaction for people with mild to moderate dementia and reported a significant cognitive improvement in favor of the social interaction group compared to the control group who was engaged in cognitive training only.

Social cognition is supported by an extensive system of limbic, cortical and subcortical brain regions. Many of these regions are also involved in episodic memory, semantic memory and other cognitive functions. Thus, it is possible that aspects of cognitive processing, which are activated through social interaction will also strengthen these cognitive abilities.

Engaging in social interaction usually consists of complex cognitive and memory challenges, which in turn may aid in enhancing cognitive abilities and cognitive reserve Training in a group setting can provide participants with an opportunity to problem-solve with a relevant peer group and allow individuals to gain comfort from sharing their concerns about memory.

The purpose of the current study was therefore to determine the effectiveness of a strategy-based cognitive training approach combined with a socially interactive learning method on cognitive performance and transferability of training gains for older adults.

Procedure:

Meetings of both groups were held in public community centers. A pre-session meeting was devoted to explaining the research objectives and signing consent forms. Prior to the first training meeting and after the program ended, cognitive evaluation measurements were taken individually from each subject. Before the final cognitive evaluation, participants were reminded to use the learned strategies.

Sample size assessment:

A priori power analysis using pilot data and the SimR package in R (version 1.0.5) suggested that 30 participants would provide sufficient power (power > 80%) to detect the critical strategy training plus social interaction effect on cognitive performance.

Statistical analysis plan:

Data will be analyzed with IBM SPSS Statistics for Windows, version 23 (IBM Corp., Armonk, N.Y., USA). The main analysis 'שד a mixed-design analysis that compares the experimental conditions (between-subject factors) regarding their effect on cognitive performance in 4 cognitive tests and 2-time points (within-subjects variables).

Being tested
Social interaction combined with cognitive training based on mnemonic strategies., Social interaction group
Keywords
Cognitive training, Strategy training, Older adults, Mnemonic, Social interaction
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social interaction combined with cognitive training based on mnemonic strategies.Other

    In the first six sessions, participants in the experimental group learned and practiced six different mnemonic strategies: Story-Formation strategy, Face-Name strategy, Peg-Word strategy, Chunking strategy, Key-Word strategy and the Method of Loci. In the following six sessions, in order to assimilate the strategies they learned, participants practiced the same tasks.

  • Social interaction groupOther

    In the control group, each session also began with a conversation between the participants. The sessions then dealt with the content of interpersonal communication and the acquisition of tools for creating interpersonal relationships. Participants were asked to share the way they used the tools they acquired between sessions and received feedback from the other participants

Study groups in NCT05016336
Study groupRoleWhat they receive
strategy-based cognitive training + social interactionExperimentalThe experimental group received twelve 60 minutes sessions of strategy-based cognitive training. (i.e., training in mnemonic memory strategies). We chose to train multiple strategies instead of a single one in effort to reach larger training gains. each session began with engaging conversations between the researcher and participants. After each practice trial, participants were encouraged to share their ideas/stories/associations or visual images (mnemonic uses) in turn. All other participants were allowed to give feedback relating to what can be learned from each mnemonic use or give their own ideas on how they think it can be improved.
Receives: Other: Social interaction combined with cognitive training based on mnemonic strategies.
social interactionActive comparatorThe social interaction control group received the same number of group meetings but without the strategy training. Meetings content consisted of providing tools for making social connections, providing tools for interpersonal communication and raising the participant's sense of personal well-being through group contact.
Receives: Other: Social interaction group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verbal Fluency Test (Chiu et al., 1997)

    Participants were asked to say aloud as many words as possible belonging to a given category (animal's category and fruit and vegetables category) within a period of sixty seconds.

    Measured: Change from baseline (before treatment) to immediately after treatment (12 weeks)

Secondary outcomes (3)
  1. Wechsler Digit Span Test (Wechsler 2008)

    Series of digits were presented verbally at a rate of one digit per second. Subjects were required to repeat the digits verbally in the order presented.

    Measured: Change from baseline (before treatment) to immediately after treatment (12 weeks)

  2. Words Recall Test (Fairchild et al., 2013)

    Subjects were asked to remember a list of 16 words and to recall the list after a 5-min delay.

    Measured: Change from baseline (before treatment) to immediately after treatment (12 weeks)

  3. Corsi Block-Tapping Test (Corsi 1972)

    The task involves mimicking the researcher as he taps a sequence of up to nine identical spatially separated blocks.

    Measured: Change from baseline (before treatment) to immediately after treatment (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2021
  2. Study start18 Nov 2018
  3. Primary completion3 Feb 2019
  4. Study completion24 Feb 2019

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study included 32 subjects, 20 in the experimental group and 12 in the control group. The experimental group received 12 sessions of strategy-based cognitive training combined with a socially interactive learning method. The control group received the same number of meetings but without the strategy training. Participants were recruited from designated active groups in the community.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016336
Sponsor's protocol ID
08082021ML
Status last verified
Aug 2021
First submitted
17 Aug 2021
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets generated during and/or analyzed during the current study are available from the main author.

Publications

  • Choi M. Association between social participation and cognitive function among community-dwelling older adults living alone: Analysis of a nationally representative survey. Int J Nurs Pract. 2020 Aug;26(4):e12841. doi: 10.1111/ijn.12841. Epub 2020 May 27.

    PubMed 32458529
  • Hikichi H, Kondo K, Takeda T, Kawachi I. Social interaction and cognitive decline: Results of a 7-year community intervention. Alzheimers Dement (N Y). 2016 Dec 21;3(1):23-32. doi: 10.1016/j.trci.2016.11.003. eCollection 2017 Jan.

    PubMed 29067317
  • Krueger KR, Wilson RS, Kamenetsky JM, Barnes LL, Bienias JL, Bennett DA. Social engagement and cognitive function in old age. Exp Aging Res. 2009 Jan-Mar;35(1):45-60. doi: 10.1080/03610730802545028.

    PubMed 19173101
  • Park DC, Gutchess AH, Meade ML, Stine-Morrow EA. Improving cognitive function in older adults: nontraditional approaches. J Gerontol B Psychol Sci Soc Sci. 2007 Jun;62 Spec No 1:45-52. doi: 10.1093/geronb/62.special_issue_1.45.

    PubMed 17565164
  • Chan MY, Haber S, Drew LM, Park DC. Training Older Adults to Use Tablet Computers: Does It Enhance Cognitive Function? Gerontologist. 2016 Jun;56(3):475-84. doi: 10.1093/geront/gnu057. Epub 2014 Jun 13.

    PubMed 24928557
  • Iizuka A, Suzuki H, Ogawa S, Kobayashi-Cuya KE, Kobayashi M, Inagaki H, Sugiyama M, Awata S, Takebayashi T, Fujiwara Y. Does social interaction influence the effect of cognitive intervention program? A randomized controlled trial using Go game. Int J Geriatr Psychiatry. 2019 Feb;34(2):324-332. doi: 10.1002/gps.5024. Epub 2018 Dec 10.

    PubMed 30430635
  • Myhre JW, Mehl MR, Glisky EL. Cognitive Benefits of Online Social Networking for Healthy Older Adults. J Gerontol B Psychol Sci Soc Sci. 2017 Sep 1;72(5):752-760. doi: 10.1093/geronb/gbw025.

    PubMed 26984523
  • Cavallini E, Dunlosky J, Bottiroli S, Hertzog C, Vecchi T. Promoting transfer in memory training for older adults. Aging Clin Exp Res. 2010 Aug;22(4):314-23. doi: 10.3275/6704. Epub 2009 Nov 27.

    PubMed 19966535
  • Valentijn SA, van Hooren SA, Bosma H, Touw DM, Jolles J, van Boxtel MP, Ponds RW. The effect of two types of memory training on subjective and objective memory performance in healthy individuals aged 55 years and older: a randomized controlled trial. Patient Educ Couns. 2005 Apr;57(1):106-14. doi: 10.1016/j.pec.2004.05.002.

    PubMed 15797159
  • Rouse HJ, Small BJ, Faust ME. Assessment of Cognitive Training & Social Interaction in People with Mild to Moderate Dementia: A Pilot Study. Clin Gerontol. 2019 Jul-Sep;42(4):421-434. doi: 10.1080/07317115.2019.1590489. Epub 2019 Mar 21.

    PubMed 30895883
  • Bennett DA, Schneider JA, Tang Y, Arnold SE, Wilson RS. The effect of social networks on the relation between Alzheimer's disease pathology and level of cognitive function in old people: a longitudinal cohort study. Lancet Neurol. 2006 May;5(5):406-12. doi: 10.1016/S1474-4422(06)70417-3.

    PubMed 16632311
  • Ertel KA, Glymour MM, Berkman LF. Effects of social integration on preserving memory function in a nationally representative US elderly population. Am J Public Health. 2008 Jul;98(7):1215-20. doi: 10.2105/AJPH.2007.113654. Epub 2008 May 29.

    PubMed 18511736
  • Verhaeghen P, Marcoen A, Goossens L. Improving memory performance in the aged through mnemonic training: a meta-analytic study. Psychol Aging. 1992 Jun;7(2):242-51. doi: 10.1037//0882-7974.7.2.242.

    PubMed 1535198
  • Flynn TM, Storandt M. Supplemental group discussions in memory training for older adults. Psychol Aging. 1990 Jun;5(2):178-81. doi: 10.1037//0882-7974.5.2.178.

    PubMed 2378683
  • Chiu HF, Chan CK, Lam LC, Ng KO, Li SW, Wong M, Chan WF. The modified Fuld Verbal Fluency Test: a validation study in Hong Kong. J Gerontol B Psychol Sci Soc Sci. 1997 Sep;52(5):P247-50. doi: 10.1093/geronb/52b.5.p247.

    PubMed 9310094

Questions about this trial

What is this clinical trial studying?

A study testing Social interaction combined with cognitive training based on mnemonic strategies. and Social interaction group in people with Cognitive Decline, run by Bar-Ilan University, Israel at 1 site in Israel.

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 1 inclusion and 1 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 26 Aug 2021. 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 Israel. 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?

Verbal Fluency Test (Chiu et al., 1997) (time frame: Change from baseline (before treatment) to immediately after treatment (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05016336, which also lists 18 linked publications.

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 26 Aug 2021.

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