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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMeserret Aslan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: ACT-Based Online WorkshopExperimental treatment 1 intervention
Group B: ACT-Based Chatbot CounselingExperimental treatment 1 intervention
Group C: Standard CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline, Week 2, Week 4, and Month 6

Secondary outcomes

1

Change in DASS-21 Stress Subscale Score

Stress symptoms will be assessed using the Stress subscale of the 21-item Depression Anxiety Stress Scale (DASS-21). The stress subscale consists of 7 items rated from 0 to 3. Subscale scores are calculated according to the DASS-21 scoring procedure, with higher scores indicating greater stress symptom severity.

Time frame
Baseline, Week 2, Week 4, and Month 6
2

Change in DASS-21 Anxiety Subscale Score

Anxiety symptoms will be assessed using the Anxiety subscale of the 21-item Depression Anxiety Stress Scale (DASS-21). The anxiety subscale consists of 7 items rated from 0 to 3. Subscale scores are calculated according to the DASS-21 scoring procedure, with higher scores indicating greater anxiety symptom severity.

Time frame
Baseline, Week 2, Week 4, and Month 6
3

Change in DASS-21 Depression Subscale Score

Depressive symptoms will be assessed using the Depression subscale of the 21-item Depression Anxiety Stress Scale (DASS-21). The depression subscale consists of 7 items rated from 0 to 3. Subscale scores are calculated according to the DASS-21 scoring procedure, with higher scores indicating greater depressive symptom severity.

Time frame
Baseline, Week 2, Week 4, and Month 6

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Meserret Aslan

Lead sponsor

Atlas University

Sponsor institution

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