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IRCT20260711070128N1 IRCT 2026-11-06 Islamic Azad University Effectiveness of Integrated Logotherapy and Life Coaching on Meaning in Life and Life Satisfaction Investigating the Effectiveness of Integrated Logotherapy and Life Coaching Intervention on Meaning in Life and Life Satisfaction among Adults 2026-10-12 anticipated 80 Complete https://irct.ir/trial/91563 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study is a parallel two-arm (intervention and control) randomized controlled trial (RCT). Its unique design feature is the application of a mixed-methods approach, specifically a Sequential Explanatory Design. Accordingly, the research is conducted in two consecutive phases: the first phase comprises a randomized controlled trial with repeated measures (pre-test, post-test, and one-month follow-up) for quantitative data collection and analysis. In the second phase, following the analysis of quantitative data, qualitative data are collected through semi-structured interviews with a subsample of the intervention group to provide a deeper explanation of the findings and to understand the participants' lived experiences. These qualitative data will be analyzed using thematic analysis. This mixed-methods design enables a more comprehensive understanding of how and why the intervention works, Randomization description: This is a two-arm parallel randomized controlled trial. The unit of randomization is individual. After eligibility assessment, written informed consent, and completion of the pre-test, participants are randomly allocated to the intervention group (n=40) and the control group (n=40) with a 1:1 allocation ratio. Simple randomization was used; no quasi-random methods such as hospital sequence, day of week, or file number were applied. No stratified or blocked randomization was used, and the study is not cluster-randomized. The random sequence is generated using random number generation software (SPSS/R or Random.org) with a 1:1 ratio for 80 participants. For allocation concealment, the generated sequence is placed in opaque, sealed, sequentially numbered envelopes by a research collaborator independent of recruitment and screening. Each envelope is opened only after participant registration and completion of the pre-test, in sequential order. Group allocation is performed by a person not involved in screening or intervention delivery. The study is open-label; participants and the intervention facilitator are aware of group assignment, and no blinding was performed. To reduce bias, data analysis will be conducted using group codes without revealing group labels and based on the intention-to-treat principle. N/A Meaning in Life and Life Satisfaction. Intervention group: 9 sessions of integrated logotherapy and life coaching intervention delivered in a group format, twice a week (each session 60-75 minutes). The first 4 sessions focus on logotherapy principles including "Will to Meaning," freedom and responsibility, creative values (meaningful creation), experiential values (depth of life moments), and attitudinal values (suffering as an existential task), culminating in the development of a personal "Meaning Statement." The next 4 sessions utilize the T-GROW model (Topic, SMART Goal setting, Reality assessment using the CIA model, Options exploration, and Will/Action planning) to translate existential insights into practical goals and actionable plans. The final session (9th) is dedicated to integration, reflection, and designing a maintenance plan. The intervention is delivered by a trained researcher in logotherapy and coaching.. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD), Full Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) template, Clinical Study Report (CSR), Analysis Codes, and Data Dictionary. All raw participant data including pre-test, post-test, and follow-up scores of MLQ and SWLS, demographic information, and group allocation will be shared after the complete removal of direct identifiers (names, phone numbers, etc.) and replacing them with unique random codes. When: Access will begin 6 months after the publication of the main results and will be available for 5 years. To whom: Academic researchers, postgraduate students, and professionals in psychology and related fields, regardless of their institutional affiliation. Conditions: Data will be used for non-commercial research and educational purposes only. Requestors must agree to cite the original source, refrain from any attempt at re-identification of participants, and sign a Data Use Agreement (DUA). Where to obtain: Arash Ghavidel (Principal Investigator) Email: ghavidel.a55@gmail.com Phone: +98 915 916 1875 Postal Address: No. 31, Emamat 6, Emamat Blvd., Vakilabad Blvd., Mashhad, Iran. Postal Code: 9188894573 How to obtain: Submit a written request via email to the Principal Investigator. Review of the request by the PI and Supervisor (maximum 2 weeks). Signing the Data Use Agreement by the requestor. Secure data transfer (typically 2 to 4 weeks after approval). Comments: For any further clarification regarding the data sharing process, please contact the Principal Investigator using the provided contact details.
public Arash Ghavidel
No. 31, Emamat 6, Emamat Blvd., Vakilabad Blvd., Mashhad, Razavi Khorasan, Iran
mashhad Iran (Islamic Republic of) 9188894573 +98 51 3604 4841 ghavidel.a55@gmail.com Islamic Azad University scientific mohammad hossein delshad
Ferdowsi St. Razi Razi St. 2, No. 14, 2nd floor
Torbat Heydariyeh Iran (Islamic Republic of) 9519633885 +98 51 5222 1508 delshad264@gmail.com Torbate-Heidaria University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age range 30-45 years at least high school diploma informed consent to participate no concurrent psychotherapy or professional coaching interventions 30 years 45 years Both Active severe psychiatric disorders (based on initial screening) Behavior Intervention group: 9 sessions of integrated logotherapy and life coaching intervention delivered in a group format, twice a week (each session 60-75 minutes). The first 4 sessions focus on logotherapy principles including "Will to Meaning," freedom and responsibility, creative values (meaningful creation), experiential values (depth of life moments), and attitudinal values (suffering as an existential task), culminating in the development of a personal "Meaning Statement." The next 4 sessions utilize the T-GROW model (Topic, SMART Goal setting, Reality assessment using the CIA model, Options exploration, and Will/Action planning) to translate existential insights into practical goals and actionable plans. The final session (9th) is dedicated to integration, reflection, and designing a maintenance plan. The intervention is delivered by a trained researcher in logotherapy and coaching. Meaning in Life score (Presence of Meaning and Search for Meaning) measured by Meaning in Life Questionnaire (MLQ) at three time points: pre-test, post-test, and one-month follow-up. Timepoint: Pre-test (before intervention), Post-test (immediately after intervention), and Follow-up (one month after intervention). Method of measurement: Participants complete the Meaning in Life Questionnaire (MLQ). The MLQ includes 10 items measuring two subscales ("Presence of Meaning" and "Search for Meaning") on a 7-point Likert scale. Life Satisfaction score measured by Satisfaction with Life Scale (SWLS) at three time points: pre-test, post-test, and one-month follow-up. Timepoint: Pre-test (before intervention), Post-test (immediately after intervention), and Follow-up (one month after intervention). Method of measurement: Completion of the standard Meaning in Life Questionnaire (MLQ) and Satisfaction with Life Scale (SWLS) by participants at three time points (pre-test, post-test, and one-month follow-up). Islamic Azad University Approved 2026-10-05 Ethics Committee of Islamic Azad University, North Tehran Branch No. 11, Khajeh Nasir St., South Palestine St., Enghelab St., Tehran, Iran tehran Tehran Iran (Islamic Republic of)