Effects of Individual and Group Occupational Therapy on General Self-Efficacy, Psychological Well-Being, Personal Independence and Occupational Therapy in Older Adults

January 30, 2017 updated by: Abel Toledano-González, University of Malaga

EFFECTS OF INDIVIDUAL AND GROUP OCCUPATIONAL THERAPY ON GENERAL SELF-EFFICACY AND PSYCHOLOGICAL WELL-BEING IN OLDER ADULTS

The objective of this study is to determine whether individual and/or group occupational therapy leads to changes in generalized self-efficacy and psychological well-being, and to identify the type of therapy that has the best effects on older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective

The main objective of this study is to determine whether individual and/or group occupational therapy leads to changes in generalized self-efficacy and psychological well-being, and to identify the type of therapy that has the best effects on the population of older adults. In addition, the investigators aim to determine whether there is a relationship between the different domains of psychological well-being and the sense of general self-efficacy.

Design

The research draws on a randomized experimental intervention study with a pre-post design. It compares two groups: one receiving individual therapy and the other, group therapy.

Setting

The intervention was conducted at two state-assisted residential care centers for older adults in Málaga (Spain). Each participant was first interviewed to gather sociodemographic data (age, gender, education level) as well as to verify that their scores for cognitive levels and the required skills and capabilities were sufficient to participate in the study. During this interview, the aim and length of the intervention was explained and an invitation to participate was given. All participants gave their informed consent. The care center and the Ethics Committee of the University of Málaga authorized the study. The same cognitive and emotional screening was conducted before and after the intervention. In each care center participants were randomly assigned to the two treatment groups.

Subjects

From an initial sample of 112 residents, a final sample of 74, divided into two groups of 37, was included in the study. For both groups, the inclusion criteria were: 1) able to read; 2) having normal cognitive function, scoring >22 on the Mini Mental Scale Examination, the cut-off point according to the scoring instructions of the adapted version for the Spanish population.

Method

In April 2014, after the sample was selected, participants were randomized to two groups of 34. Following assessment, the intervention began in May. The intervention lasted 6 months, after which participants were re-assessed.

The instruments used were Van Dierendonck's Spanish adaptation of Ryff´s Psychological Well-being Scale, comprising 39 items and with an internal consistency of between 0.78 and 0.81 and the Spanish adaptation of Schwarzer and Jerusalem's General Self-Efficacy Scale (GSE), with an internal consistency of 0.84 (Cronbach's alpha).

Activities were conducted in three 45-minute sessions per week. In both treatment modalities the activities included personal independence training (ADLs), sensory-motor stimulation activities, cognitive stimulation (attention, memory, language and executive function) and animal-assisted therapy (AAT). The group occupational therapy participants also received psychosocial skills training.

To describe the sample, the investigators used descriptive statistics for quantitative and qualitative variables. To analyze differences in the main study variables we applied the t-student test or the Mann-Whitney U test, depending on whether or not they followed a normal distribution. Chi square testing was used to determine the existence of differences in distribution by gender, age and educational level. To analyze the main dependent variables (self-efficacy and well-being) we conducted a repeated measures ANOVA for intra-subject and inter-subject factors. Statistical significance was established at p<0.05. Data were analyzed using SPSS, version 21.0.

Study Type

Interventional

Enrollment (Actual)

112

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

  • Spain
      • Malaga, Spain
        • Malaga

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

78 years to 95 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be able to read
  • Have normal cognitive function scoring >22 on Mini Mental Scale Examination
  • Sign informant consent
  • Apply the recommendations

Exclusion Criteria:

  • Advanced cognitive impairment
  • Fear of animals
  • Miss three time
  • Visual impairment
  • Multiple disorders
  • Hearing impairment

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual Occupational therapy
In Individual Occupational Therapy treatment the activities included personal independence training (ADLs), sensory-motor stimulation activities, cognitive stimulation (attention, memory, language and executive function) and animal-assisted therapy (AAT).
Behavioral: Individual Occupational Therapy
45 minutes 3 times per week 6 months in nursing homes (A and B)
Experimental: Group Occupational therapy
In group Occupational Therapy treatment the activities included personal independence training (ADLs), sensory-motor stimulation activities, cognitive stimulation (attention, memory, language and executive function) and animal-assisted therapy (AAT) and psychosocial skills training.
Behavioral: Group Occupational Therapy
45 minutes 3 times per week 6 months in nursing homes (A and B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ryff Questionnaire
Time Frame: 6 months
The scale of psychological well-being Ryff is formed by the complete version of 39 items with Likert responses it 1-6. The main objective this scale is to measure the degree of psychological well-being of personaa through 6 dimensions: purpose in life, self-acceptance, positive relationships, autonomy, environmental mastery and personal growth
6 months
General Self-efficacy
Time Frame: 6 months
The scale of generalized self-efficacy is a self informed through 10 items with 1-4 Likert scale responses. The main objective is to measure the degree of generalized self-efficacy of the person across 10 assertions with 4 possible answers above, in which the option that best reflects what the person thinks is marked
6 months
Barthel Index
Time Frame: 6 months
Barthel index measured through 10 items the level of dependence of the person performing the activities of daily life can vary between 0 (completely dependent) to 100 (completely independent)
6 months
Minimental MMSS
Time Frame: 6 months
The MMSE is composed of 13 items to assess with scores (0,1,2,3,4,5) according answer. the main objective is to briefly assess the mental state and allow observe the degree of progression of cognitive status through the following areas: orientation, fixation, concentration and calculation, memory, language and construction.
6 months
Geriatric Depression Scale (GDS)
Time Frame: 6 MONTHS
Geriatric Depression Scale consists of 15 items (10 negative and 5 positive) through answers (yes / no) whose content focuses on cognitive behavioral aspects related to special characteristics of the population. The main objective is to facilitate the assessment of depression in the geriatric population.
6 MONTHS

Collaborators and Investigators

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

Sponsor

University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01/2012

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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