Clinical trial NCT02906306: Effects of Individual and Group Occupational Therapy on General Self-Efficacy, Psychological Well-Being, Personal Independence and Occupational Therapy in Older Adults
Official title: EFFECTS OF INDIVIDUAL AND GROUP OCCUPATIONAL THERAPY ON GENERAL SELF-EFFICACY AND PSYCHOLOGICAL WELL-BEING IN OLDER ADULTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuality
Self-Efficacy
Well-being
Keywords: Older adults
Occupational Therapy
Self-Efficacy
Psychological Well-being
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 112
Sex: ALL
Minimum age (years): 78
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ryff Questionnaire
timeFrame: 6 months
measure: General Self-efficacy
timeFrame: 6 months
measure: Barthel Index
timeFrame: 6 months
measure: Minimental MMSS
timeFrame: 6 months
measure: Geriatric Depression Scale (GDS)
timeFrame: 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Malaga
Study officials:
References:
citation: Toledano-Gonzalez A, Labajos-Manzanares T, Romero-Ayuso DM. Occupational Therapy, Self-Efficacy, Well-Being in Older Adults Living in Residential Care Facilities: A Randomized Clinical Trial. Front Psychol. 2018 Aug 7;9:1414. doi: 10.3389/fpsyg.2018.01414. eCollection 2018.