Psychological FlexibilityNICU-ACTNCT07837609
ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU
A study testing ACT-Based Online Psychoeducational Workshop and ACT-Based Chatbot Counseling in people with Psychological Flexibility and Psychological Distress, run by Meserret Aslan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psychological Flexibility, Psychological Distress, Neonatal Intensive Care Unit
- What is being tested?
- ACT-Based Online Psychoeducational Workshop and ACT-Based Chatbot Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Effect of Two Acceptance and Commitment Therapy Based Counseling Methods on Psychological Flexibility in Mothers With Infants Hospitalized in the Neonatal Intensive Care Unit
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.
Read more
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.
Read the detailed description
This study is a three-arm, parallel-group randomized controlled trial designed to evaluate the effects of two ACT-based counseling delivery methods on psychological flexibility and psychological distress among mothers whose infants are hospitalized in the NICU.
The study will be conducted at the Neonatal Intensive Care Units of Istanbul Atlas University Hospital and Gaziosmanpasa Training and Research Hospital in Istanbul, Türkiye. A total of 135 eligible mothers will be enrolled, with approximately 45 participants allocated to each study group.
Participants will be assigned to the three groups using stratified block randomization. Stratification will be based on study site and infant gestational status, with the aim of achieving balanced allocation across the intervention groups.
ACT-Based Online Workshop Group:
Participants assigned to this group will receive an individual, synchronous online ACT-based psychoeducational session lasting approximately 60 minutes. The session will include present-moment awareness and mindfulness, acceptance of difficult emotional experiences, 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 Group:
Participants assigned to this group will use a mobile chatbot-based intervention for four weeks. The chatbot will provide structured ACT-based psychoeducation, brief exercises, and supportive guidance related to mindfulness, acceptance, cognitive defusion, values, and committed action. The chatbot will not diagnose mental health conditions, provide medical treatment, prescribe medication, or make clinical decisions. Predefined safety messages and referral pathways will be used when potentially high-risk expressions are detected.
Standard Care Group:
Participants assigned to the control group will receive the routine information, counseling, and clinical care normally provided to mothers in the NICU. No additional ACT-based intervention will be provided.
Data will be collected using a descriptive information form, the Psychological Flexibility Scale, and the 21-item Depression Anxiety Stress Scale (DASS-21). Psychological flexibility will be the primary outcome. Depression, anxiety, and stress scores will be secondary outcomes. Assessments will be conducted at baseline, Week 2, Week 4, and Month 6.
The primary objective is to compare changes in psychological flexibility between the two ACT-based intervention groups and the standard care group. Secondary objectives are to compare changes in depression, anxiety, and stress symptoms and to examine whether the effects of the interventions are maintained during long-term follow-up.
- Conditions
- Psychological Flexibility, Psychological Distress, Neonatal Intensive Care Unit, Acceptance & Commitment Therapy
- Being tested
- ACT-Based Online Psychoeducational Workshop, ACT-Based Chatbot Counseling
- Keywords
- Acceptance and Commitment Therapy, Psychological Flexibility, Neonatal Intensive Care Unit, Perinatal Mental Health, Psychological Distress, Digital Health, Online Counseling, Psychoeducation, Midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-Based Online Psychoeducational WorkshopBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, Week 4, and Month 6
Secondary outcomes (3)
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.
Measured: Baseline, Week 2, Week 4, and Month 6
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.
Measured: Baseline, Week 2, Week 4, and Month 6
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.
Measured: Baseline, Week 2, Week 4, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological FlexibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meserret Aslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meserret Aslan, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837609
- Sponsor's protocol ID
- IUC-NICU-ACT-2026-01
- Acronym
- NICU-ACT
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At present, there is no plan to share individual participant data (IPD) with external researchers. Study data will be coded and stored securely in accordance with the approved study protocol and applicable data protection regulations. Access to the research data will be restricted to the principal investigator and authorized members of the research team. Data will be retained securely for five years after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Acceptance and Commitment Therapy Based Counseling Methods on Psychological Flexibility in Mothers With Infants Hospitalized in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07837609
- Acronym / sponsor ID
- NICU-ACT / IUC-NICU-ACT-2026-01
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Meserret AslanUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a three-arm, parallel-group randomized controlled trial designed to evaluate the effects of two ACT-based counseling delivery methods on psychological flexibility and psychological distress among mothers whose infants are hospitalized in the NICU.
The study will be conducted at the Neonatal Intensive Care Units of Istanbul Atlas University Hospital and Gaziosmanpasa Training and Research Hospital in Istanbul, Türkiye. A total of 135 eligible mothers will be enrolled, with approximately 45 participants allocated to each study group.
Participants will be assigned to the three groups using stratified block randomization. Stratification will be based on study site and infant gestational status, with the aim of achieving balanced allocation across the intervention groups.
ACT-Based Online Workshop Group:
Participants assigned to this group will receive an individual, synchronous online ACT-based psychoeducational session lasting approximately 60 minutes. The session will include present-moment awareness and mindfulness, acceptance of difficult emotional experiences, 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 Group:
Participants assigned to this group will use a mobile chatbot-based intervention for four weeks. The chatbot will provide structured ACT-based psychoeducation, brief exercises, and supportive guidance related to mindfulness, acceptance, cognitive defusion, values, and committed action. The chatbot will not diagnose mental health conditions, provide medical treatment, prescribe medication, or make clinical decisions. Predefined safety messages and referral pathways will be used when potentially high-risk expressions are detected.
Standard Care Group:
Participants assigned to the control group will receive the routine information, counseling, and clinical care normally provided to mothers in the NICU. No additional ACT-based intervention will be provided.
Data will be collected using a descriptive information form, the Psychological Flexibility Scale, and the 21-item Depression Anxiety Stress Scale (DASS-21). Psychological flexibility will be the primary outcome. Depression, anxiety, and stress scores will be secondary outcomes. Assessments will be conducted at baseline, Week 2, Week 4, and Month 6.
The primary objective is to compare changes in psychological flexibility between the two ACT-based intervention groups and the standard care group. Secondary objectives are to compare changes in depression, anxiety, and stress symptoms and to examine whether the effects of the interventions are maintained during long-term follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT-Based Online Workshop | Experimental | Behavioral: ACT-Based Online Psychoeducational WorkshopParticipants 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. |
| ACT-Based Chatbot Counseling | Experimental | Behavioral: ACT-Based Chatbot CounselingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-Based Online Psychoeducational WorkshopParticipants 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. | Behavioural | ACT-Based Online Workshop |
| ACT-Based Chatbot CounselingParticipants 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. | Behavioural | ACT-Based Chatbot Counseling |
Primary outcome
Change in Psychological Flexibility Scale Total Score
Time frame: Baseline, Week 2, Week 4, and Month 6
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.
3 secondary outcomes
Change in DASS-21 Stress Subscale Score
Time frame: Baseline, Week 2, Week 4, and Month 6
Change in DASS-21 Anxiety Subscale Score
Time frame: Baseline, Week 2, Week 4, and Month 6
Change in DASS-21 Depression Subscale Score
Time frame: Baseline, Week 2, Week 4, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. At present, there is no plan to share individual participant data (IPD) with external researchers. Study data will be coded and stored securely in accordance with the approved study protocol and applicable data protection regulations. Access to the research data will be restricted to the principal investigator and authorized members of the research team. Data will be retained securely for five years after completion of the study.
Related trials for Psychological Flexibility
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
Active, not recruitingPhase 2
Novel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma
Depression, Anxiety
Recruiting
FlexED: National Substudy
Eating Disorders, Body Image
Not yet recruiting
Mindfulness Training in University Badminton Athletes
Competitive Anxiety, Attentional Control
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-Based Online Psychoeducational Workshop and ACT-Based Chatbot Counseling in people with Psychological Flexibility and Psychological Distress, run by Meserret Aslan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Flexibility Scale Total Score (time frame: Baseline, Week 2, Week 4, and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.