PMID- 34328428
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210825
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 7
DP  - 2021 Jul 30
TI  - A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity 
      Psychological Intervention for Fear of Memory Loss and Quality of Life in Older 
      Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) 
      Study.
PG  - e30514
LID - 10.2196/30514 [doi]
LID - e30514
AB  - BACKGROUND: Dementia is the most feared disease associated with aging. Prolonged 
      fears about memory loss and dementia can have harmful consequences even in the 
      absence of cognitive decline. Fear of dementia is associated with poorer health 
      outcomes and psychological well-being and increased memory failures in older 
      adults. OBJECTIVE: We will conduct a randomized controlled trial to determine the 
      feasibility of a tailored, web-based mindfulness program to reduce fear of memory 
      loss and increase quality of life in older adults experiencing heightened fear. 
      METHODS: Eighty participants will be recruited and divided into 2 groups (40 in 
      each group). One group will receive psychoeducation plus mindfulness training. A 
      second group will receive psychoeducation, mindfulness training, and additional 
      modules targeting maladaptive behavioral avoidance (ie, social and cognitive 
      withdrawal). RESULTS: Our recent etiological model posits that maladaptive 
      behavioral avoidance strategies critically underlie psychosocial dysfunction 
      associated with fear of memory loss. Thus, we predict better outcomes in the 
      second group, including reduced fear of memory loss (primary outcome), Alzheimer 
      disease, anxiety, and subjective memory failures, and increased quality of life 
      (secondary outcomes). Outcome measures will be applied at 5 time points (before, 
      baseline, interim, and after the intervention, and at 3-month follow-up). Data 
      will be analyzed using mixed models and correlations. CONCLUSIONS: Results from 
      this study will contribute to the current literature on dementia-related fear and 
      improve our understanding of how to effectively address and reduce these fears. 
      TRIAL REGISTRATION: ClinicalTrials.gov NCT04821960; 
      https://clinicaltrials.gov/ct2/show/NCT04821960. INTERNATIONAL REGISTERED REPORT 
      IDENTIFIER (IRRID): PRR1-10.2196/30514.
CI  - (c)Patricia O'Loughlin, Pavithra Pavithra, John Regan, Marc Bennett, Rachel Knight, 
      Bert Lenaert, Melissa Marquez, Michelle Taddeo, James Griffith, Rita Shapiro, 
      Francesca Farina. Originally published in JMIR Research Protocols 
      (https://www.researchprotocols.org), 30.07.2021.
FAU - O'Loughlin, Patricia
AU  - O'Loughlin P
AUID- ORCID: 0000-0003-1332-0495
AD  - School of Psychology, Trinity College Dublin, Dublin, Ireland.
FAU - Pavithra, Pavithra
AU  - Pavithra P
AUID- ORCID: 0000-0001-5643-0956
AD  - School of Psychology, Trinity College Dublin, Dublin, Ireland.
FAU - Regan, John
AU  - Regan J
AUID- ORCID: 0000-0003-0023-7406
AD  - School of Psychology, Trinity College Dublin, Dublin, Ireland.
FAU - Bennett, Marc
AU  - Bennett M
AUID- ORCID: 0000-0001-7217-4059
AD  - Medical Research Council, Cognition and Brain Sciences Unit, University of 
      Cambridge, United Kingdom.
FAU - Knight, Rachel
AU  - Knight R
AUID- ORCID: 0000-0002-8315-2864
AD  - Medical Research Council, Cognition and Brain Sciences Unit, University of 
      Cambridge, United Kingdom.
FAU - Lenaert, Bert
AU  - Lenaert B
AUID- ORCID: 0000-0002-6250-8833
AD  - Faculty of Health, Medicine and Life Sciences, Limburg Brain Injury Centre, 
      Maastricht University, Netherlands.
FAU - Marquez, Melissa
AU  - Marquez M
AUID- ORCID: 0000-0003-3154-7220
AD  - Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
FAU - Taddeo, Michelle
AU  - Taddeo M
AUID- ORCID: 0000-0002-1478-8826
AD  - Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
FAU - Griffith, James
AU  - Griffith J
AUID- ORCID: 0000-0002-4840-8692
AD  - Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
FAU - Shapiro, Rita
AU  - Shapiro R
AUID- ORCID: 0000-0003-3123-7943
AD  - VA Chicago Health Care System, Chicago, IL, United States.
FAU - Farina, Francesca
AU  - Farina F
AUID- ORCID: 0000-0002-4410-4368
AD  - Global Brain Health Institute, Trinity College Institute of Neuroscience, Trinity 
      College Dublin, Dublin 2, Ireland.
LA  - eng
SI  - ClinicalTrials.gov/NCT04821960
PT  - Journal Article
DEP - 20210730
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8367123
OTO - NOTNLM
OT  - behavioral activation
OT  - dementia
OT  - fear
OT  - memory loss
OT  - mindfulness
OT  - older adults
COIS- Conflicts of Interest: None declared.
EDAT- 2021/07/31 06:00
MHDA- 2021/07/31 06:01
PMCR- 2021/07/30
CRDT- 2021/07/30 12:16
PHST- 2021/05/18 00:00 [received]
PHST- 2021/06/01 00:00 [accepted]
PHST- 2021/06/01 00:00 [revised]
PHST- 2021/07/30 12:16 [entrez]
PHST- 2021/07/31 06:00 [pubmed]
PHST- 2021/07/31 06:01 [medline]
PHST- 2021/07/30 00:00 [pmc-release]
AID - v10i7e30514 [pii]
AID - 10.2196/30514 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 Jul 30;10(7):e30514. doi: 10.2196/30514.