Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors

August 25, 2022 updated by: Chin-Tsung Shen, Mackay Medical College

Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors With Disabilities: A Randomized Controlled Trial

This study aimed to evaluate the effects of a biopsychosocial-spiritual (BPS-S) Group intervention on quality of life among seniors with disabilities in long-term care residential settings.

Study Overview

Status

Completed

Conditions

Detailed Description

Background: Traditionally, biomedical care approach has been insufficient to meet the complex needs of older people living with multi-morbidity. Promoting whole-person wellness and better quality of life becomes a key goal of care in residential long-term care facilities. The integrative approaches composed of physio-psycho-social and spiritual components might be a viable strategy to assist older adults accept uncontrollable life changes and enhance holistic wellness.

Purpose: The study purpose was to develop and evaluate the effects of 8-week biopsychosocial-spiritual (BPS-S) group intervention versus usual care on self-perception of quality of life (QoL) and meaning in life among seniors with disability in residential care home at mid- and post-intervention, and at a 1-month follow up.

Methods: This single-blind randomized controlled trail with repeated measures design was conducted in residential long-term care facilities. Both the experimental groups (EG) and the control group (CG) received routing group activities based on their institution's schedule. Additionally, the EG received 8 sessions of weekly BPS-S group therapy for 80 minutes each. The baseline characteristics of residents with disabilities (including demographic information, length of stay in the institution and medical conditions) were collected using a data sheet, and activities of daily living of these residents were measured using the Barthel Index. To evaluate the effectiveness of the BPS-S group therapy, the primary outcomes including "participants' overall QOL" and the secondary outcome "meaning in life" were assessed at four time points: before, mid- and post- intervention and at a 1-month follow up. Quality of Life Index (QLI)-Part I and Purpose in Life (PIL) test were used to measure these outcome variables, respectively.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • New Taipei City, Taiwan
        • Department of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. being 65 years of age or older;
  2. living in the institution for at least 1 month;
  3. Barthel Index scores under 90;
  4. no hearing, visual impairment and infectious diseases;
  5. being able to follow instructions and participate in group activities.

Exclusion Criteria:

have the diagnosis of major depression.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the Biopsychosocial-Spiritual Group Intervention
The experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.
The Experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.
No Intervention: weekly general chatting activities
The Control group received weekly general chatting activities for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life summary scores before intervention to 4-week post intervention.
Time Frame: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
Quality of life was measured using the Chinese version of the Quality of Life Index (QLI)-Part I. It contains 33 items measuring satisfaction regarding the four domains (health and functioning, social and economic domain, psychological/spiritual wellness, and family). The QLI-Part I is a six-point satisfaction rating scale from very unsatisfied (1) to very satisfied (6). To determine the scores, each satisfaction item is recoded from -0.25 to 0.25, and both the overall and subscale scores of the QLI-Part I calculated by following step by step scoring instructions ranges from 0 to 30; highest values represent better quality of life
The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Meaning in life summary scores before intervention to 4-week post intervention.
Time Frame: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
Meaning in life was measured using the Purpose in Life Test (PIL). It is a 20-item scale designed to measure the degree of perceived meaning and purpose in individual life. Each item of the original scale is rated on a seven-point scale along a continuum from one extreme feeling (0) to the opposite feeling (7). However, too many options may be difficult for older adults to make ratings, so the original seven-point scale was modified to a five-point scale in this study, with 3 representing a neutral response. Possible scores range from 20 to 100, where higher scores indicate stronger sense of meaning in life.
The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yi-Heng Chen, Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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