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Not Yet Recruiting NCT07837609

ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU

Conditions: Psychological Flexibility, Psychological Distress, Neonatal Intensive Care Unit, Acceptance & Commitment Therapy

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 135
Sponsor: Meserret Aslan

Summary

This randomized controlled trial will evaluate two Acceptance and Commitment Therapy (ACT)-based counseling approaches for mothers whose infants are hospitalized in a Neonatal Intensive Care Unit (NICU). Mothers of infants in the NICU may experience high levels of stress, anxiety, and depressive symptoms. ACT is an approach that aims to improve psychological flexibility by helping people respond more effectively to difficult thoughts, emotions, and stressful experiences. A total of 135 mothers will be enrolled from two hospitals in Istanbul, Türkiye. Participants will be randomly assigned to one of three groups: an individual online ACT-based workshop, an ACT-based chatbot counseling program, or standard care. Mothers in the online workshop group will receive one individual 60-minute online session that includes mindfulness, acceptance, cognitive defusion, values clarification, and committed action exercises. Mothers in the chatbot group will receive ACT-based psychoeducation, guided exercises, and supportive digital counseling through a mobile application for four weeks. Mothers in the control group will receive the routine information and care normally provided in the NICU. Psychological flexibility will be the primary outcome. Depression, anxiety, and stress symptoms will be evaluated as secondary outcomes. Assessments will be completed at baseline, Week 2, Week 4, and at the 6-month follow-up. The study aims to determine whether ACT-based online and digital counseling can improve psychological flexibility and reduce psychological distress among mothers of infants hospitalized in the NICU.

Eligibility Criteria

Inclusion Criteria: Biological mother of an infant currently hospitalized in the Neonatal Intensive Care Unit (NICU) at one of the participating study sites. Aged 18 years or older. Able to read and understand Turkish. Has access to a smartphone and uses a messaging application. Willing to participate in the study and provide written informed consent. Exclusion Criteria: Presence of a psychotic disorder or current use of psychiatric medication. Mother of an infant admitted to the NICU for same-day care only. Mother of an infant receiving palliative care or considered to be in the terminal stage. Unable to read and understand Turkish.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07837609). StuddyBuddy aggregates publicly available trial information.