Emotion-Focused Mindfulness Therapy: A Feasibility Study for Late Life Anxiety

NCT04415528 | Completed

• 1 other identifier: 1509
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Canadians 65 and older experience anxiety at a rate of 6.4%, affecting more than 300,000 people. In Ontario, 5.6% of adults 65 and older have anxiety, representing over 100,000 people. Eastern Ontario primary care clinics report significantly higher numbers of adults 65 and older diagnosed with anxiety at between 28% and 30%, representing approximately 4,600 people diagnosed with anxiety. Costs to the Canadian health care system of anxiety in community dwelling adults aged 65 and older have been estimated at $61.2 to $119.8 million per 1,000,000 people. These costs can reasonably be expected to increase by 2021 when the percentage of older adults 65+ with mental illness is estimated to be approximately 30% of the older population base. Anxiety in older adults has been linked retaining new information and the instrumental activities of daily living, sleep disturbance, suicidal ideation particularly among men, and increased use of health care services. Present pharmacological treatments for anxiety in older adults have met with limited success. Mindfulness-based interventions (MBIs) are an area of research interest in the treatment of anxiety. The use of MBIs has shown a trend toward self-reported lower levels of chronic stress and psychological stress among older adults small scale RCTs and qualitative studies. Emotion focused mindfulness meditation therapy (EFMT) is a MBI that shows promise. EFMT has been demonstrated to reduce symptoms of anxiety in general populations. EFMT's focus on meditation and the felt sense of emotions, rather than learning new material, may make it a promising intervention for reducing symptoms of anxiety for older adults who often report normal aging problems such as general forgetfulness and difficulty with word recall. EFMT may be a potentially promising intervention that has not yet been tested in older adults. EFMT can be offered in primary care, community and hospital settings. Further research is required to determine if EFMT could reduce anxiety for older adults.

Conditions

Anxiety

Keywords

anxiety; aging and health; adults aged 65 and older; mindfulness based intervention; meditation

Outcome Measures

Primary Outcomes (3)

• Determine if participants can be recruited, enrolled, and retained

  Data will be gathered and measured on the number of potential participants referred and screened for eligibility, participants meeting eligibility requirements, participants enrolled, and participants completing the intervention. Dates defining the recruitment period will be reported. Number of participants referred by physicians and number of participants who call the PI directly will be combined for each site.

  8 weeks

• Determine if participants can adhere to all components of the intervention

  To determine if participants can adhere to the intervention, attendance of 6 / 8 sessions, data on attendance will be gathered. Data for the other measures of adherence of meditation, journaling and reporting will also be gathered. In the tradition of MBI research, the intervention will be considered complete if participants are able to attend a minimum of six of eight meetings (Santorelli, Florence Meleo-Meyer, Koerbel, \& Kabat-Zinn, 2017). Data gathered on adherence to meditation, journaling and reporting aspects of the intervention through weekly reporting forms to be completed by each participant through an online survey. Participants will answer yes or no to whether they engaged in each component. Participants are not required to practice at home, however data will be gathered on the frequency and duration of home practice meditation and journaling to determine if there is a relationship to outcomes.

  From time of enrollment to end of intervention at 8 weeks

• Geriatric Anxiety Inventory, to assess change over time

  The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.

  Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index (PQSI) to to assess change over time

  Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention

• Multifactorial Memory Questionnaire (Troyer & Rich, 2002), to assess change over time

  Time 1: at enrollment; Time 2: end of intervention at 8 weeks; Time 3: 8 weeks post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will begin receiving the group intervention within one - two weeks of Time 1 assessment. This group will receive Time 2 assessments at the end of the group delivery. Time 3 assessments will be administered eight weeks after the completion of group delivery.

Other: Emotion-Focused Mindfulness Therapy

Wait listed control group

ACTIVE COMPARATOR

The wait listed control group will be assessed at Time 1, eight weeks before receiving the intervention. This group will receive Time 2 assessments at the beginning of their group delivery. This group will complete Time 3 assessments eight weeks after the completion of group delivery.

Other: Emotion-Focused Mindfulness Therapy

Interventions

Emotion-Focused Mindfulness Therapy OTHER

EFMT is a group intervention of 8weekly meetings of 2.5 hours with 10 - 12 participants per group. Participants are provided instruction that encourages noting and experiencing bodily sensations and emotions during meditations. Meditations are conducted in silence for between 20 and 35 minutes. Participants are asked to journal their recollection of the meditation and experiences that arise for them as they journal. Each participant then describes their experience in meditation, with the facilitator offering empathic exploration to support transforming negative emotions into adaptive emotions. The study will be conducted in an online PHIPPA protected platform and has been modified to accommodate electronic delivery. Maximum number of participants per group will be six, and each session will be 1.5 hours. Data will be collected at three points by a research assistant to evaluate the feasibility of EFMT for older adults and determine whether anxiety is influenced by the intervention.

Intervention group; Wait listed control group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Stacey Hatch: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (9)

• Gayner, B. (2019). Emotion-focused mindfulness therapy. Person-Centered & Experiential Psychotherapies, 1-23. https://doi.org/10.1080/14779757.2019.1572026

  BACKGROUND

• Statistics Canada. (2012). Table 13-10-0465-01: Mental health indicators. https://doi.org/https://doi.org/10.25318/1310046501-eng

  BACKGROUND

• Wisco, R., & Haber, C. (n.d.). A feasibility study of an emotion focused-mindfulness group. In Press.

  BACKGROUND

• Vasiliadis HM, Dionne PA, Preville M, Gentil L, Berbiche D, Latimer E. The excess healthcare costs associated with depression and anxiety in elderly living in the community. Am J Geriatr Psychiatry. 2013 Jun;21(6):536-48. doi: 10.1016/j.jagp.2012.12.016. Epub 2013 Feb 6.

  PMID: 23567409 RESULT

• Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.

  PMID: 11773220 RESULT

• Pachana NA, Byrne GJ, Siddle H, Koloski N, Harley E, Arnold E. Development and validation of the Geriatric Anxiety Inventory. Int Psychogeriatr. 2007 Feb;19(1):103-14. doi: 10.1017/S1041610206003504.

  PMID: 16805925 RESULT

• Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998 Jul;45(1):5-13. doi: 10.1016/s0022-3999(97)00298-5.

  PMID: 9720850 RESULT

• Hatch S, Finlayson M, Rej S, Kessler D. Virtually-Delivered Emotion Focused Mindfulness Therapy (EFMT) Group vs. Wait-List Control for Late-Life Anxiety: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2023 Oct;31(10):767-782. doi: 10.1016/j.jagp.2023.04.007. Epub 2023 Apr 19.

  PMID: 37169708 DERIVED

• Hatch S, Kessler D, Finlayson M, Rej S. Video-delivered emotion-focused mindfulness therapy for late- life anxiety: study protocol for a feasibility randomized controlled trial. Pilot Feasibility Stud. 2021 Sep 3;7(1):169. doi: 10.1186/s40814-021-00905-0.

  PMID: 34479632 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Stacey Hatch, PhDcandidate

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study involves partial disclosure to prevent confirmation bias on the part the research assistant who will be administering assessments. The research assistant will be blinded to the study purpose throughout the study. Participants will be informed that there will be different phases of data collection, and provision of the intervention. The research assistant will not be informed of participant allocation to the intervention group or the wait list control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Stacey Hatch, PhD candidate

Model Details: This will be a small pilot RCT study that will use a wait list control trial design. Participants will be randomly allocated to either the intervention or control group

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: August 3, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)