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Abstract：
BACKGROUND: Hematopoietic cell transplantation (HCT) is a highly invasive and life-threatening treatment for hematological neoplasms and some types of cancer that can challenge the patient\'s meaning structures. Restoring meaning (i.e., building more flexible and significant explanations of the disease and treatment burden) can be aided by strengthening psychological flexibility by means of an Acceptance and Commitment Therapy (ACT) intervention. Thus, this trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT compared to a minimally enhanced usual care (mEUC) control group. The trial will be enhanced with a single-case experimental design (SCED), where ACT interventions will be compared between individuals with various pre-intervention intervals.
METHODS: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning.
CONCLUSIONS: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap.
BACKGROUND: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024.
METHODS: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning.
CONCLUSIONS: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap.
BACKGROUND: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024.
摘要：
背景：造血细胞移植（HCT）是一种对血液肿瘤和某些类型的癌症的高度侵入性和危及生命的治疗方法，这些癌症可以挑战患者的意义结构。恢复含义(即，通过接受和承诺疗法（ACT）干预来增强心理灵活性，可以帮助建立对疾病和治疗负担的更灵活和重要的解释）。因此，本试验旨在研究与最低限度强化常规护理(mEUC)对照组相比,ACT干预对HCT后患者意义形成过程的影响以及改变的潜在机制.该试验将通过单例实验设计(SCED)得到加强，其中ACT干预措施将在具有各种干预前间隔的个体之间进行比较。
方法：总共，将招募192名符合首次自体或同种异体HCT的患者进行双臂平行随机对照试验，将在线自助14天ACT培训与教育课程进行比较（HCT后的建议）。在这两种情况下，参与者将在门诊期间每天接受一次短期调查和干预建议(每天约5-10分钟).双盲评估将在基线进行，在干预期间,立即,1个月,干预后3个月。此外,6-9名参与者将被邀请参加SCED，并在完成ACT干预之前随机分配到干预前测量长度（1-3周）。随后在第2次和第3次干预后测量进行7天观察.主要结果是意义相关的痛苦。次要结果包括心理灵活性，有意义的应对，意义，和福祉以及全球和情境意义。
结论：这项试验是第一项整合ACT和意义制定框架以减少意义相关困扰的研究，刺激意义的创造过程，并提高HCT接受者的福祉。通过统计上严格的具体方法来查看对谁以及何时有效，将加强对干预措施的测试，以解决接受HCT的患者特有的生存问题。由于HCT人群获得干预措施的机会有限，基于网络的ACT自助计划可能会填补这一空白。
背景：ClinicalTrials.govID：NCT06266182。2024年2月20日注册。
方法：总共，将招募192名符合首次自体或同种异体HCT的患者进行双臂平行随机对照试验，将在线自助14天ACT培训与教育课程进行比较（HCT后的建议）。在这两种情况下，参与者将在门诊期间每天接受一次短期调查和干预建议(每天约5-10分钟).双盲评估将在基线进行，在干预期间,立即,1个月,干预后3个月。此外,6-9名参与者将被邀请参加SCED，并在完成ACT干预之前随机分配到干预前测量长度（1-3周）。随后在第2次和第3次干预后测量进行7天观察.主要结果是意义相关的痛苦。次要结果包括心理灵活性，有意义的应对，意义，和福祉以及全球和情境意义。
结论：这项试验是第一项整合ACT和意义制定框架以减少意义相关困扰的研究，刺激意义的创造过程，并提高HCT接受者的福祉。通过统计上严格的具体方法来查看对谁以及何时有效，将加强对干预措施的测试，以解决接受HCT的患者特有的生存问题。由于HCT人群获得干预措施的机会有限，基于网络的ACT自助计划可能会填补这一空白。
背景：ClinicalTrials.govID：NCT06266182。2024年2月20日注册。
