- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06533202
Psycho-educational Intervention Programme for Comprehensive Preparation for Retirement: Study Protocol
Study Protocol for a Randomised Controlled Trial: Effect of a Psycho-educational Intervention Programme for Comprehensive Preparation for Retirement and the New Phase of Life
Background: The transition to retirement can be a challenging event, necessitating the adjustment of new routines, roles and expectations. Such modifications have the potential to impact the individual's quality of life and psychosocial well-being. t is of the utmost importance to develop intervention programmes that prepare people for retirement, with the objective of facilitating a positive and healthy transition.
Methods: A parallel randomised controlled clinical trial with two arms will be conducted. The study will be conducted at the Faculty of Psychology of the University of Salamanca (USAL) in Spain. The study will recruit individuals aged 60 years or older who are already retired or who will retire within the next five years. The participants will be divided into two groups: the intervention group (IG), which will undergo a comprehensive psychoeducational intervention programme, and the control group (CG), which will engage in a controlled follow-up. The programme will comprise 12 sessions over a period of three months. All participants will be assessed at the outset and conclusion of the study, as well as after three months, during which time data regarding their socio-demographic characteristics and responses to the following scales will be collected: The World Health Organization Quality of Life Measure - Brief Version (WHOQOL-BREF), the Retirement Attitudes Scale (EAJ), the Satisfaction With Life Scale (SWLS), the Questionnaire of Stereotypes towards Old Age (CENVE), the Acceptance and Action Questionnaire-II (AAQ-II), the MOS Questionnaire of Perceived Social Support (MOS), the General Health Questionnaire (GHQ), the Generalised Self-Efficacy Scale (EAG) and the Self-Regulation Scale (EAR).
Discussion: The objective of this study is to enhance the comprehension and implementation of intervention programmes in anticipation of retirement and the subsequent phase of life. To this end, a comprehensive psychoeducational intervention is proposed, with the aim of improving quality of life and attitudes towards retirement, increasing life satisfaction, psychological flexibility, perceived social support and general health, self-efficacy and self-regulation, and reducing stereotypes about ageing. The programme is designed to equip individuals with the skills and knowledge to navigate the challenges and opportunities associated with the transition to retirement.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Salamanca, Spain, 37005
- Castilla y León
-
Contact:
- Sara Jiménez García-Tizón, PhD
- Phone Number: 923294500
- Email: sarajim@usal.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be retired or nearing retirement (within 5 years)
- Be 60 years of age or older
- Voluntarily sign the consent form to participate
- Complete the initial assessment
Exclusion Criteria:
- No evidence of literacy difficulties or a significant deficit in language comprehension
- Not meet any of the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Education Programme
Why: At the end of the baseline assessment, participants will receive instructions and recommendations to facilitate a positive and healthy transition to retirement, as part of an education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow. What (materials): Instructions and recommendations for an education programme. What (procedures): Participants will receive instructions and recommendations on how to facilitate a positive and healthy transition to retirement as part of an education programme. How: The participants will receive the material individually at the commencement of the programme. When and for how long: The intervention consists of a single session and details of the time and duration will be provided to participants. |
At the end of the baseline assessment, participants will receive instructions and recommendations to facilitate a positive and healthy transition to retirement, as part of an education programme.
These will focus on the benefits of an active lifestyle and general guidelines to follow.
|
|
Experimental: Psychoeducational Programme
Why: The programme is based on a psychoeducational intervention that aims to facilitate a positive and healthy transition into retirement. What (materials): projector, computer, screen, presentation of content, stationery, chairs, tables and self-recording of home tasks. What (procedures): Patients assigned to the experimental group will follow a psychoeducational programme structured and supervised at the University of Salamanca, consisting of a education programme combined with a psychoeducational programme. Who will carry out the interventions: The content is divided into six modules: (I) Introduction to retirement from a psychosocial approach, (II) Health and retirement, (III) Financial security and the process of successful retirement, (IV) Status and retirement, (V) Leisure and retirement, and (VI) My personal project (Table 1). When and for how long: Each participant will receive 4 sessions per month for 3 months, for a total of 12 sessions. |
The objective of this type of programme is to equip individuals with the knowledge and skills required to navigate the challenges and capitalise on the opportunities presented by retirement.
In particular, the programme strives to enhance the quality of life and attitudes towards retirement, elevate levels of life satisfaction, psychological flexibility, perceived social support and general health, self-efficacy and self-regulation, and mitigate stereotypes associated with ageing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World Health Organization Quality of Life Measure - Brief Version (WHOQOL-BREF)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Quality of life.
The range of scores is from 26 to 100 points.
The higher the score, the better the quality of life.
|
Baseline; up to 24 weeks; 3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retirement Attitudes Scale (EAJ)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Attitudes towards retirement.
The range of scores is from 20 to 140 points.
The final scores indicate more negative attitudes the higher the value obtained.
|
Baseline; up to 24 weeks; 3 months follow up
|
|
Satisfaction With Life Scale (SWLS)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Satisfaction with life.
The range of scores is from 5 to 25 points.
A higher score indicates that the person is generally satisfied with his/her life.
|
Baseline; up to 24 weeks; 3 months follow up
|
|
Questionnaire of Stereotypes towards Old Age (CENVE)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Stereotypes about ageing.
The range of score is from 5 to 20 points.
High scores indicate a high degree of belief in negative stereotypes of ageing.
|
Baseline; up to 24 weeks; 3 months follow up
|
|
The acceptance and action questionnaire-II (AAQ-II)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Psychological inflexibility.
The range of score is from 7 to 49 points.
High scores indicate more psychological inflexibility.
|
Baseline; up to 24 weeks; 3 months follow up
|
|
MOS Questionnaire of Perceived Social Support (MOS)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Perceived social support.
The overall scores range from 20 to 100 points.
The higher the score, the more social support the individual perceives.
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Baseline; up to 24 weeks; 3 months follow up
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|
Goldberg General Health Questionnaire (GHQ)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Perceived general health.
The overall scores range from 0 to 36 points.
Higher scores correspond to a higher level of perceived health.
|
Baseline; up to 24 weeks; 3 months follow up
|
|
Generalised Self-Efficacy Scale (EAG)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Self-efficacy.
Scores range from 10 to 40 points.
Higher scores indicate higher levels of self-efficacy.
|
Baseline; up to 24 weeks; 3 months follow up
|
|
Self-Regulation Scale (EAR)
Time Frame: Baseline; up to 24 weeks; 3 months follow up
|
Self-regulation.
Scores range from 7 to 35 points.
Higher scores on the scale indicate a greater ability to control attention in the pursuit of goals, while lower scores may suggest difficulties in maintaining focus and attention to goals.
|
Baseline; up to 24 weeks; 3 months follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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