ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU (NICU-ACT)
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.
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：ACT-Based Online Workshop
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. |
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. |
|
実験的：ACT-Based Chatbot Counseling
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. |
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. |
|
介入なし：Standard Care
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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Psychological Flexibility Scale Total Score
時間枠：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. |
Baseline, Week 2, Week 4, and Month 6
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in DASS-21 Stress Subscale Score
時間枠：Baseline, Week 2, Week 4, and Month 6
|
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. |
Baseline, Week 2, Week 4, and Month 6
|
|
Change in DASS-21 Anxiety Subscale Score
時間枠：Baseline, Week 2, Week 4, and Month 6
|
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. |
Baseline, Week 2, Week 4, and Month 6
|
|
Change in DASS-21 Depression Subscale Score
時間枠：Baseline, Week 2, Week 4, and Month 6
|
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. |
Baseline, Week 2, Week 4, and Month 6
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- IUC-NICU-ACT-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。