Meaning-focused Intervention in the Army

NCT ID: NCT05336292

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2022-12-13

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.

Detailed Description

The structure of the program will include tools for the promotion of meaning through the understanding of oneself, the practice of mindfulness, strengths, values, analysis of objectives and action plans to achieve them . In the MLI+ER group, training in emotional regulation skills will be included as an element that enhances the meaning of life, as suggested by some studies.

Objectives and hypotheses Studio 1

The investigators set ourselves the following objectives:

1. Explore the feasibility of enhancing the sense of life and work through an intervention based on the sense of life.

2. To explore the usefulness of an emotional regulation component in an intervention based on a meaningful life to enhance the effects on a meaningful life and a meaningful at work.

3. To explore the possible impact of an intervention based on meaningful life in other relevant aspects such as meaningful at work, burnout, work commitment, well-being, emotional dysregulation and depression

4. Check if an intervention based on meaningful life is acceptable and feasible in a non-clinical population in the military context.

5. Explore aspects to improve in the protocol based on the quantitative and qualitative results.

Study 2 Objectives: To compare the effects of a MLI-based intervention compared to a combined MLI+ER program and to analyze its impact on subjective well-being, emotional regulation, depressive symptomatology, burnout, and work commitment, as well as the mechanisms of change.

Hypothesis 1: The intervention group MLI and ER+MLI will present higher scores in meaningful life and meaningful at work after the intervention with respect to the subjects of the control group.

Hypothesis 2: The MLI and MLI+ER intervention group will present higher scores in subjective well-being, emotional regulation, depressive symptomatology, burnout and work commitment (secondary indicators) after the intervention compared to the control group subjects.

Hypothesis 3: Compared to the MLI group, the MLI+ER group will show greater increases in well-being (i.e., PHI subscale), emotional regulation, and meaningful life after the intervention.

Hypothesis 4: Participants in both interventions will show high levels of acceptability and satisfaction with the intervention.

The sample of this research will be workers of the Spanish Armed Forces, once the project is approved by the Research Ethics Committee of the Complutense University of Madrid. Participants will sign an informed consent form and receive an information sheet with the purpose of the research before starting the intervention.

The pilot study will be carried out with the first 18 participants in the program, being excluded from the total expected sample size. The estimated sample size is made from the G-Power 3.1 software, taking as a reference the effect size of 0.37 suggested by the literature on the effect of Mindfulness interventions on the vital sense (Chu, 2020). The investigators take a conservative approach, adopting an effect size of 0.30 which may correspond according to Cohen (d) to a medium-moderate effect size. The expected total sample size will be 120 participants.

The participants will be recruited voluntarily in a Military Unit in Madrid. Talks will be held between potential participating staff. Volunteers will register through their offices, in turn, the registration will be sent by organic chain to our department. Once the request of the interested personnel has been made, participants will be contacted via email or telephone. Participants will fill in all the pre, post and follow-up measures (via google forms) and will be randomly assigned to one of the three groups; intervention based on meaningful life (MLI); intervention based on meaningful life and emotional regulation (MLI+ER) or control group. Once assigned to the group, the program will begin with six sessions, once a week, for 120 minutes.

The design proposed to achieve the first objective will be a qualitative case study in order to investigate the individual effects at two moments: pre-post intervention, in the set of measures described above and in the five questions to evaluate individual satisfaction with the program. It will be carried out with the first 18 participants who complete the program and will form part of the pilot study.

For the rest of the objectives included in the second study, the proposed design is experimental with random assignment to the three groups; the two intervention modalities and control group. Repeated measures will be applied in three moments, pre and post and follow-up at 4 months. At the end of the data collection of all the participants, there will be a sample of 120 participants (excluding the 18 participants of the pilot study); (MLI) n= (40), (MLI+ER) n= (40) and (CG) n= (40). A quantitative and qualitative research design will be adopted to investigate the satisfaction, acceptability and feasibility of the program through the post measures and degree of acceptability-satisfaction with the intervention (CSQ-8).

Given the conditions of the size of the sample and to control the variability due to other factors, such as the programming of activities in the organization. The personnel will be organized randomly, in groups of 8 people in each modality, distributed in seven shifts of six sessions. In each turn, the two modalities will be carried out at the same time, in addition to their control group. This is justified by the type of sample and the conditions of the organization.

Regarding the analysis techniques provided for in the first study, a descriptive analysis of the mean of the first participants will be carried out, in addition to the non-parametric tests and qualitative analysis of the satisfaction comments. For the second study, once the data collection is finished, the pertinent tests of homoscedasticity and normality tests will be carried out to check if the data are parametric, and thus be able to use parametric techniques. In this case, the tests used would be: normality tests, group equivalence, Anova for repeated measures, Anova for independent samples, Regression analysis to evaluate the predictive capacity of the variables.

Conditions

Meaningful Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Meaningful life intervention

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).

Group Type: ACTIVE_COMPARATOR

Meaningful life-focused intervention

Intervention Type: BEHAVIORAL

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

Meaningful life and emotional regulation-focused intervention

Intervention Type: BEHAVIORAL

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

Control Group

Intervention Type: BEHAVIORAL

This group does not do any intervention

Meaningful life and emotional regulation

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

Group Type: ACTIVE_COMPARATOR

Meaningful life-focused intervention

Intervention Type: BEHAVIORAL

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

Meaningful life and emotional regulation-focused intervention

Intervention Type: BEHAVIORAL

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

Control Group

Intervention Type: BEHAVIORAL

This group does not do any intervention

Control group

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

Group Type: ACTIVE_COMPARATOR

Meaningful life-focused intervention

Intervention Type: BEHAVIORAL

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

Meaningful life and emotional regulation-focused intervention

Intervention Type: BEHAVIORAL

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

Control Group

Intervention Type: BEHAVIORAL

This group does not do any intervention

Interventions

Meaningful life-focused intervention

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

Intervention Type: BEHAVIORAL

Meaningful life and emotional regulation-focused intervention

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

Intervention Type: BEHAVIORAL

Control Group

This group does not do any intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• The inclusion criteria for the research will be active military personnel, or an active worker, over 18 years of age.

Exclusion Criteria:

• The exclusion criteria will be being on medical or psychiatric leave or having a significant level of depression (PHQ greater than or equal to 10). People excluded for this reason will be referred to a psychological care service.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Militaries units

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Gonzalo Hervas, Ph.D

Role: CONTACT

ghervas@psi.ucm.es

(34) 91-3943105.

Diana C. Ríos, Psychologist

Role: CONTACT

dcrios@ucm.es

(34) 606695480

Facility Contacts

Diana C. Ríos, Psychologist

Role: primary

dcrios@ucm.es

(34) 606695480

References

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

Ryff, C. (1989).

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: 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.

Reference Type: 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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 11556941 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 29999537 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26172498 (View on PubMed)

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

Reference Type: BACKGROUND

Study Documents

Document Type: Individual Participant Data Set

Data will be made available upon reasonable request

View Document

Other Identifiers

UComplutenseMadrid-Meaningful

Identifier Type: -

Identifier Source: org_study_id