Comparison of the effectiveness of acceptance and commitment therapy (ACT) and unified transdiagnostic treatment (UP) in colorectal cancer patients
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Intervention 1: Intervention group 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow & et al will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 2: Intervention group 2: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, & Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 3: Control group: This group of 15 randomly selected individuals will receive no treatment for two months. However, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Acceptance and Commitment Therapy or Unified Transdiagnostic Treatment.
Primary outcome(s): Psychological distress. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Depression Anxiety and Stress Scale.;Meta-emotion beliefs. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Meta-Emotions Scale.;Acceptance. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Acceptance and Action Questionnaire.;Post-traumatic growth. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Post-traumatic Growth Questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: acceptance and commitment therapy, unified transdiagnostic treatment and control. First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = acceptance and commitment therapy, B = unified transdiagnostic treatment, and C = control group. In this study with three groups A, B and C, we create the following six groups and assign a number from 1 to 6 to each group: ABC-ACB-BAC-BCA-CAB-CBA, Then, using the table of random numbers, we contract that if the n
干预1:干预组1:采用巴洛(Barlow)等人所著《统一跨诊断治疗手册》(Unified Transdiagnostic Treatment)为框架的治疗方案,严格遵循实验流程实施:每周开展1次治疗,每次时长约90分钟,总计8次治疗,持续周期为2个月。评估将分三个时间节点进行:治疗中期、治疗结束时,以及治疗结束后2个月。
干预2:干预组2:采用海斯(Hayes)、斯特罗萨尔(Strosahl)与威尔逊(Wilson)所著《接纳与承诺疗法手册》(Acceptance and Commitment Therapy)为框架的治疗方案,严格遵循实验流程实施:每周开展1次治疗,每次时长约90分钟,总计8次治疗,持续周期为2个月。评估将分三个时间节点进行:治疗中期、治疗结束时,以及治疗结束后2个月。
干预3:对照组:该组纳入15名随机选取的被试,在2个月研究周期内不接受任何治疗。为补偿该组被试参与研究的付出,在研究周期结束后,将为其免费提供接纳与承诺疗法(Acceptance and Commitment Therapy)或统一跨诊断治疗(Unified Transdiagnostic Treatment)中的一种进行强化干预。
主要结局指标:
1. 心理困扰(Psychological distress):评估时间点为治疗中期、治疗结束时及治疗结束后2个月,测量工具为《抑郁焦虑压力量表》(Depression Anxiety and Stress Scale);
2. 元情绪信念(Meta-emotion beliefs):评估时间点为治疗中期、治疗结束时及治疗结束后2个月,测量工具为《元情绪量表》(Meta-Emotions Scale);
3. 接纳程度(Acceptance):评估时间点为治疗中期、治疗结束时及治疗结束后2个月,测量工具为《接纳与行动问卷》(Acceptance and Action Questionnaire);
4. 创伤后成长(Post-traumatic growth):评估时间点为治疗中期、治疗结束时及治疗结束后2个月,测量工具为《创伤后成长问卷》(Post-traumatic Growth Questionnaire)。
研究设计:
随机化设计:随机分组,设盲情况:未设盲,安慰剂使用情况:未使用安慰剂,分组方式:平行对照,研究目的:支持性研究。
随机化方法说明:由统计顾问采用区组随机化法,具体流程如下:将被试随机分为3组,分别为接纳与承诺疗法(Acceptance and Commitment Therapy)组、统一跨诊断治疗(Unified Transdiagnostic Treatment)组与对照组。首先生成符合入组标准的被试名单并进行编码。区组随机化通过构建序列区组,确保各组内被试人数尽可能均衡。将三组分别以拉丁字母编码:A=接纳与承诺疗法(Acceptance and Commitment Therapy)组,B=统一跨诊断治疗(Unified Transdiagnostic Treatment)组,C=对照组。本研究包含A、B、C三组,因此生成如下6种区组序列并分别赋值1至6:ABC-ACB-BAC-BCA-CAB-CBA。随后通过随机数字表进行随机化,若n(原文未完整表述)。
创建时间:
2021-01-15



