NCT06533202

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 24, 2024

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • World Health Organization Quality of Life Measure - Brief Version (WHOQOL-BREF)

    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 Outcomes (8)

  • Retirement Attitudes Scale (EAJ)

    Baseline; up to 24 weeks; 3 months follow up

  • Satisfaction With Life Scale (SWLS)

    Baseline; up to 24 weeks; 3 months follow up

  • Questionnaire of Stereotypes towards Old Age (CENVE)

    Baseline; up to 24 weeks; 3 months follow up

  • The acceptance and action questionnaire-II (AAQ-II)

    Baseline; up to 24 weeks; 3 months follow up

  • MOS Questionnaire of Perceived Social Support (MOS)

    Baseline; up to 24 weeks; 3 months follow up

  • +3 more secondary outcomes

Study Arms (2)

Education Programme

ACTIVE COMPARATOR

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.

Behavioral: Education Programme

Psychoeducational Programme

EXPERIMENTAL

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.

Behavioral: Psychoeducational Programme

Interventions

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.

Psychoeducational Programme

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.

Education Programme

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No evidence of literacy difficulties or a significant deficit in language comprehension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castilla y León

Salamanca, 37005, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The work of sequencing, randomisation, recruitment and allocation of the trial sample will be carried out by research staff who are not involved in the assessments or interventions of each group, thus avoiding any potential bias in the trial. Participants will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which they have been assigned, thus masking the blinded assessment by third parties in the clinical trial. In addition, the researchers responsible for the statistical analysis of the trial will be blinded in order to increase the rigour of the trial process and thus the scientific quality.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 1, 2024

Study Start

September 9, 2024

Primary Completion

September 9, 2025

Study Completion

December 31, 2025

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

They will be made available to researchers in the document repository "GREDOS" of the University of Salamanca, Spain.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available at the end of the study.
Access Criteria
Open access for researchers.
More information

Locations