IndividualityNCT02906306
Effects of Individual and Group Occupational Therapy on General Self-Efficacy, Psychological Well-Being, Personal Independence and Occupational Therapy in Older Adults
A study testing Individual Occupational Therapy and Group Occupational Therapy in people with Individuality and Self-Efficacy, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 78 to 95 years
- Conditions the study is for
- Individuality, Self-Efficacy, Well-being
- What is being tested?
- Individual Occupational Therapy and Group Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 78 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be able to read
- Have normal cognitive function scoring >22 on Mini Mental Scale Examination
- Sign informant consent
- Apply the recommendations
Who cannot join
- Advanced cognitive impairment
- Fear of animals
- Miss three time
- Visual impairment
- Multiple disorders
- Hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Individuality, Self-Efficacy, Well-being
- Being tested
- Individual Occupational Therapy, Group Occupational Therapy
- Keywords
- Older adults, Occupational Therapy, Self-Efficacy, Psychological Well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Occupational TherapyBehavioural
45 minutes 3 times per week 6 months in nursing homes (A and B)
Group Occupational TherapyBehavioural
45 minutes 3 times per week 6 months in nursing homes (A and B)
| Study group | Role | What they receive |
|---|---|---|
| Individual Occupational therapy | Experimental | 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). Receives: Behavioral: Individual Occupational Therapy |
| Group Occupational therapy | Experimental | 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. Receives: Behavioral: Group Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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
Measured: 6 months
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)
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IndividualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abel Toledano-González, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906306
- Sponsor's protocol ID
- 01/2012
- Status last verified
- Jan 2017
- First submitted
- 7 Sep 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30131748
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF INDIVIDUAL AND GROUP OCCUPATIONAL THERAPY ON GENERAL SELF-EFFICACY AND PSYCHOLOGICAL WELL-BEING IN OLDER ADULTS
- ClinicalTrials.gov ID
- NCT02906306
- Acronym / sponsor ID
- 01/2012
- Conditions
- Individuality, Self-Efficacy, Well-being
- Keywords
- Older adults, Occupational Therapy, Self-Efficacy, Psychological Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Occupational therapy | Experimental | Behavioral: Individual Occupational TherapyIn 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). |
| Group Occupational therapy | Experimental | Behavioral: Group Occupational TherapyIn 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. |
Who may qualify
- Ages
- 78 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Be able to read
- Have normal cognitive function scoring >22 on Mini Mental Scale Examination
- Sign informant consent
- Apply the recommendations
Key exclusion criteria (6 listed)
- Advanced cognitive impairment
- Fear of animals
- Miss three time
- Visual impairment
- Multiple disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Occupational Therapy45 minutes 3 times per week 6 months in nursing homes (A and B) | Behavioural | Individual Occupational therapy |
| Group Occupational Therapy45 minutes 3 times per week 6 months in nursing homes (A and B) | Behavioural | Group Occupational therapy |
Primary outcome
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
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
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)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 30131748Toledano-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Occupational Therapy and Group Occupational Therapy in people with Individuality and Self-Efficacy, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ryff Questionnaire (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.