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

Well-being Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906306
• Other study ID #: 01/2012
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: January 30, 2017
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 78 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Individuality
• Self-Efficacy
• Well-being

Intervention

Behavioral:
• Individual Occupational Therapy
45 minutes 3 times per week 6 months in nursing homes (A and B)
• Group Occupational Therapy
45 minutes 3 times per week 6 months in nursing homes (A and B)

Locations

Country	Name	City	State
Spain	Malaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ryff Questionnaire	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
Primary	General Self-efficacy	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
Primary	Barthel Index	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
Primary	Minimental MMSS	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
Primary	Geriatric Depression Scale (GDS)	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