Clinical trial NCT05336292: Meaning-focused Intervention in the Army
Official title: Acceptability and Preliminary Results of a Meaning-focused Intervention in the Army: A Case Series Study. Assessment of Meaningful Life Intervention in the Spanish Forces
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meaningful Life
Keywords: Meaningful life
Meaningful at work
Propose
Well-being
Emotional regulation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Change in Meaningful life
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
measure: Change in Meaningful at work
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
measure: Change in Well-being
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
Secondary outcomes:
measure: Change in Burnout
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
measure: Change in Engagement at work
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
measure: Change in Emotional regulation
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
measure: Change in Depression after intervention
timeFrame: "pre intervention", "immediately after intervention" and "4 months after the end of the intervention"
measure: Client Satisfaction Questionnaire after intervention and open questions
timeFrame: "immediately after intervention"
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Militaries units
Study officials:
References:
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