NCT05336292

Brief Summary

The purpose of this research is to contribute to the empirical study of meaningful life interventions in the general population, since it is a sample of active professionals. To get the research objectives, two studies are proposed. In the present investigation the effects of two interventions in meaningful life will be analyzed and will be compared with a control group. The first group will be an intervention based on meaningful life (MLI), the second group an intervention based on meaningful life and emotional regulation (MIL+ER) and the third group will be a control group on the waiting list. The assignment will be random and both programs will consist of six sessions, once a week, of 120 minutes. Prior to the main study, a pilot study will be carried out with the aim of describing the possible individual benefits of the meaningful life intervention, and at the same time analyzing whether emotional regulation favors meaningful life. The acceptability and feasibility of both programs will also be evaluated.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

April 20, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

March 17, 2022

Last Update Submit

April 12, 2022

Conditions

Keywords

Meaningful lifeMeaningful at workProposeWell-beingEmotional regulation

Outcome Measures

Primary Outcomes (3)

  • Change in Meaningful life

    Meaningful life Questionnaire; MLQ de Steger M., 2006, It is a 10-item instrument with two subscales that measure presence and the search for meaning in life. Items are rated on a Likert scale from 1 (Absolutely false) to 7 (Absolutely true). A minimum score of 24 points on each subscale reflects higher levels of presence and search for meaning in life, respectively.

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

  • Change in Meaningful at work

    Work and Meaningful Inventory; WAMI, Steger M., 2012; It is a 10-item instrument. It measures the perception that the individual has about the meaning of his work. The WAMI contains 3 subscales: positive meaning at work (PM), feeling that the work one does is important, creating meaning through work (MM), building meaning in one's personal life through what one does at work job; and great motivations towards others (GG), believing that work benefits and does good for others and society in general. Each item is evaluated on a Likert-type scale ranging from 1 (Absolutely false) to 5 (Absolutely true). The total score ranges from 10 to 50, the higher the score, the more meaning experienced through the work.

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

  • Change in Well-being

    Pemberton happiness index; Vazquez C. y Hervas G., 2013; This scale is a measure of well-being that integrates hedonic and eudaimonic aspects. The scale contains 11 items of remembered well-being and 10 items of experienced well-being. The sum of these scales results in a well-being index. The recalled well-being scale has a Likert scale ranging from 0 (completely disagree) to 10 (completely agree). The well-being index has a score from 0 to 10.

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

Secondary Outcomes (5)

  • Change in Burnout

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

  • Change in Engagement at work

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

  • Change in Emotional regulation

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

  • Change in Depression after intervention

    "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"

  • Client Satisfaction Questionnaire after intervention and open questions

    "immediately after intervention"

Study Arms (3)

Meaningful life intervention

ACTIVE COMPARATOR

We will work with psychological skills, meaningful life model, mindfulness skills ,personal values, the Wellbeing Model (Ryff, 1989) . The strengths of character (Park et al., 2004) and sources meaningful life. We will identify ways to use strengths and enhance meaningful life and develop an action plan to improve strengths. ). To identify the Meaning at the work. Link our strengths and values to our goals and purposes. Apply the SMART Method to achieve meaningful goals. Visualizing Our Best Future Self (Burton \& King, 2004).

Behavioral: Meaningful life-focused interventionBehavioral: Meaningful life and emotional regulation-focused interventionBehavioral: Control Group

Meaningful life and emotional regulation

ACTIVE COMPARATOR

Program Based on meaningful life and Emotional Regulation (MLI+ER) Session 1 Emotional regulation as a path towards the meaningful life Mindfulness training (emotional mindfulness) Generate knowledge of emotions and their functioning Session 2 Emotional Psychoeducation Emotional care To Know the well-being model Carol Ryff and Vital Sense To Understand the process of emotional regulation Session 3 Strengths and Personal Values Cultivate introspection and self-knowledge (Mindfulness, Carlson, 2013; Klussman, 2020) To Know the strengths of character (Park et al., 2004) and sources of vital meaning Identify ways to use strengths and enhance the sense of life Making Core Values Real (My 80th Birthday Speech; Harris, 2009) Note: Sessions 4, 5 and 6 are the same as the intervention based on meaningful life

Behavioral: Meaningful life-focused interventionBehavioral: Meaningful life and emotional regulation-focused interventionBehavioral: Control Group

Control group

ACTIVE COMPARATOR

The waiting list will be the control group. Participants will not be part of the program. They will participate in a day of positive psychology

Behavioral: Meaningful life-focused interventionBehavioral: Meaningful life and emotional regulation-focused interventionBehavioral: Control Group

Interventions

The intervention works different skills to increase the meaningful life in the general population and specifically in the army.

Control groupMeaningful life and emotional regulationMeaningful life intervention

The intervention works different skills to increase the meaningful life and emotional regulation in the general population and specifically in the army.

Control groupMeaningful life and emotional regulationMeaningful life intervention
Control GroupBEHAVIORAL

This group does not do any intervention

Control groupMeaningful life and emotional regulationMeaningful life intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Militaries units

Madrid, 28011, Spain

RECRUITING

Related Publications (20)

  • Chu, S., & Mak, W. (2020). How Mindfulness Enhances Meaning in Life: A Meta-Analysis of Correlational Studies and Randomized Controlled Trials. Mindfulness. 11, 177-193 https://doi.org/10.1007/s12671-019-01258-9.

    BACKGROUND
  • Hicks, J., & King, L. (2009). Positive mood and social relatedness as information about meaning in life. The Journal of Positive Psychology, 4(6), 471-482. https://doi.org/10.1080/17439760903271108.

    BACKGROUND
  • Martela, F., & Steger, M. (2016). The three meanings of meaning in life: Distinguishing coherence, purpose and significance. The Journal of Positive Psychology, 11, 531-45.

    BACKGROUND
  • Ryff, C. (1989).

    BACKGROUND
  • Steger, M., Dik, B., & Duffy, R. (2012). Measuring meaningful work: The work and Meaning Inventory (WAMI). Journal of Career Assesment, 20, 322-37.

    BACKGROUND
  • Steger, M., Frazier, P., Oishi, S., & Kaler, M. (2006). The Meaning in Life Questionnaire: Assesing the Presence of and Search for Meaning in Life. Journal of Counselling Psychology, 53, 1, 80-93. DOI: 10.1037/0022-0167.53.1.80.

    BACKGROUND
  • Schaufeli, W. B., Bakker, A. B., & Salanova, M. (2006). The measurement of work engagement with a short questionnaire. A cross-national study. Educational and Psychological Measurement, 66, 701-716. https://doi.org/10.1177/0013164405282471.

    BACKGROUND
  • Park, N., Peterson, C., & Seligman, M. E. (2004). Strengths of character and well-being. Journal of social and Clinical Psychology, 23(5), 603-619. https://doi.org/10.1521/jscp.23.5.603.50748

    BACKGROUND
  • Maslach, C. & Jackson, S.E. (1981), The measurement of experienced burnout. J. Organiz. Behav., 2: 99-113. https://doi.org/10.1002/job.4030020205

    BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Hervás, G., & Jódar, R. (2008). Adaptación al castellano de la Escala de Dificultades en la Regulación Emocional The spanish version of the Difficulties in Emotion Regulation Scale. Clínica y Salud, 19(2), 139. https://psycnet.apa.org/record/2008-17752-001

    BACKGROUND
  • Harris, R. (2009). ACT Made Simple: An easy-toread primer on Acceptance and Commitment Therapy. Oakland: CA: New Har

    BACKGROUND
  • Burton, CM & King, LA. 2004. The health benefits of writing about intensely positive experiences. Journal of Research in Personality, 38: 150-163. https://doi.org/10.1016/S0092-6566(03)00058-8

    BACKGROUND
  • Shin, J., & Steger, M. (2014). Promoting Meaning and Purpose in Life. En A. C. Parks, S.M. Schueller. The Wiley-Blackwell Handbook of Psychology of Positive Psychological Interventions, First Edition. London: Willey-Blackwell.

    BACKGROUND
  • Wong, P. (2010). Meaning therapy: an integrative and positive existential psicotherapy. Journal of Contemporary Psicotherapy, 40, 85-93.

    BACKGROUND
  • Steger, M. (2017). Creating Meaning and Purpose in Work. In L. Oades, M.F. Steger, A. Della Fave, and J. Passmore, (eds.), The Wiley-Blackwell Handbook of Psychology of Positive and Strenghts-based Approacheas at work, pp. 60-81. London: Willey-Blackwell.

    BACKGROUND
  • Miao M, Gan Y. How does meaning in life predict proactive coping? The self-regulatory mechanism on emotion and cognition. J Pers. 2019 Jun;87(3):579-592. doi: 10.1111/jopy.12416. Epub 2018 Aug 5.

    PMID: 29999537BACKGROUND
  • Steger, M., & Ekman, E. (2016). Working it: Making meaning with workplace mindfulness. In: Mindfulness and positive psychology. New York: Itzvan; 2016:1-29.

    BACKGROUND
  • Carlson EN. Overcoming the Barriers to Self-Knowledge: Mindfulness as a Path to Seeing Yourself as You Really Are. Perspect Psychol Sci. 2013 Mar;8(2):173-86. doi: 10.1177/1745691612462584.

    PMID: 26172498BACKGROUND
  • Park, N., Park, M. &Peterson, C. (2010), When is the Search for Meaning Related to Life Satisfaction? Applied Psychology: Health and Well-Being, 2: 113. https://doi.org/10.1111/j.1758-0854.2009.01024.x

    BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Gonzalo Hervas, Ph.D

CONTACT

Diana C. Ríos, Psychologist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three groups; intervention based on meaningful life(MLI); intervention based on meaningful life and emotional regulation (MLI+ER) or control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 20, 2022

Study Start

November 30, 2019

Primary Completion

October 30, 2022

Study Completion

December 13, 2022

Last Updated

April 20, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request, due to the provenance of the sample.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Once the data collection and analysis is finished, they can be facilitated and shared for justified reasons during the time deemed appropriate, due to the characteristics of the sample.
Access Criteria
The data will be available upon reasonable request, due to the provenance of the sample.

Available IPD Datasets

Individual Participant Data Set Access

Locations