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

NCT07837609 | Not Yet Recruiting

• 1 other identifier: IUC-NICU-ACT-2026-01
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psychological Flexibility; Psychological Distress; Neonatal Intensive Care Unit; Acceptance & Commitment Therapy

Keywords

Acceptance and Commitment Therapy; Psychological Flexibility; Neonatal Intensive Care Unit; Perinatal Mental Health; Psychological Distress; Digital Health; Online Counseling; Psychoeducation; Midwifery

Outcome Measures

Primary Outcomes (1)

• Change in Psychological Flexibility Scale Total Score

  Psychological flexibility will be assessed using the 28-item Psychological Flexibility Scale. Items are rated on a 7-point Likert scale. The scale assesses core dimensions of psychological flexibility, including openness to experience, behavioral awareness, and valued action. Changes in total scores over time will be compared among the ACT-based online workshop, ACT-based chatbot counseling, and standard care groups.

  Baseline, Week 2, Week 4, and Month 6

Secondary Outcomes (3)

• Change in DASS-21 Stress Subscale Score

  Baseline, Week 2, Week 4, and Month 6

• Change in DASS-21 Anxiety Subscale Score

  Baseline, Week 2, Week 4, and Month 6

• Change in DASS-21 Depression Subscale Score

  Baseline, Week 2, Week 4, and Month 6

Study Arms (3)

ACT-Based Online Workshop

EXPERIMENTAL

Participants assigned to this arm will receive an individual, synchronous online ACT-based psychoeducational workshop lasting approximately 60 minutes. The session will include mindfulness and present-moment awareness, acceptance, cognitive defusion, values clarification, and committed action. Participants will also be encouraged to practice brief mindfulness exercises during the four-week follow-up period.

Behavioral: ACT-Based Online Psychoeducational Workshop

ACT-Based Chatbot Counseling

EXPERIMENTAL

Participants assigned to this arm will receive ACT-based digital counseling through a mobile chatbot for four weeks. The chatbot will provide structured psychoeducation, brief exercises, and supportive guidance based on mindfulness, acceptance, cognitive defusion, values clarification, and committed action. Participants will be able to use the application at times convenient to them throughout the intervention period.

Behavioral: ACT-Based Chatbot Counseling

Standard Care

NO INTERVENTION

Participants assigned to this arm will receive the routine information, counseling, and clinical care normally provided to mothers of infants hospitalized in the NICU. No additional ACT-based psychoeducational workshop or chatbot-based counseling intervention will be provided.

Interventions

ACT-Based Online Psychoeducational Workshop BEHAVIORAL

Participants will receive one individual, synchronous online psychoeducational session based on Acceptance and Commitment Therapy (ACT), lasting approximately 60 minutes. The session will include present-moment awareness and mindfulness exercises, acceptance of difficult emotions, cognitive defusion, values clarification, and committed action. Participants will also be encouraged to practice brief mindfulness exercises during the four-week follow-up period.

ACT-Based Online Workshop

ACT-Based Chatbot Counseling BEHAVIORAL

Participants will receive ACT-based digital counseling through a mobile chatbot for four weeks. The intervention will provide structured psychoeducation, brief guided exercises, and supportive counseling based on mindfulness, acceptance, cognitive defusion, values clarification, and committed action. The chatbot will not provide diagnosis, treatment recommendations, medication advice, or clinical decision-making. Predefined safety and referral messages will be used when risk-related expressions are detected.

ACT-Based Chatbot Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meserret Aslan: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analyses will be conducted using coded group labels (A, B, and C), with group identities concealed during analysis and revealed after completion of the analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: A three-arm, parallel-group randomized controlled trial comparing an ACT-based online workshop, ACT-based chatbot counseling, and standard care. Randomization will be stratified by study site and infant gestational status.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share