Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2))
研究概览
简要总结
The aim of the present study is to examine the effects of keeping a therapy journal (journaling) on the effectiveness of cognitive behavioral therapy (CBT). Homework assignments are a fundamental component of behavioral therapies. In line with the learning theory foundation of behavioral therapies, various types of homework are used to facilitate learning processes between therapy sessions and to enable patients to make progress. One way to enhance individual goal setting and reflection in patients is through the use of "therapy journals."
The goal of the planned project is to evaluate the effectiveness of goal-oriented journal writing as an additional element in cognitive behavioral therapy (CBT). To do this, N = 80 psychotherapy patients will be randomly assigned to two treatment groups: CBT vs. CBT + Journaling.
详细描述
As part of this study, the investigators are examining the effectiveness of certain therapeutic techniques that could improve the effectiveness of psychotherapy. A total of 80 patients will be studied, and they will be assigned to one of two treatment groups: one group will receive standard treatment, while the second group will receive additional tasks/techniques. The study will span a period of 24 sessions (short-term psychotherapy KZT1&2), during which the severity of their symptoms will be assessed at the beginning of each session (duration approx. 2 minutes). Additionally, participants will be asked to answer some questions about basic documentation (diagnoses, symptoms) at the beginning and end of the study (duration approx. 20 minutes).
The investigators assure that the personal data they collect will be protected in accordance with the European Data Protection Regulation. Collected data will only be analyzed in anonymized form, meaning without mentioning any names, and may be published in scientific journals. All data will be stored in encrypted form using personal codes. All data will be digitally archived for a period of 10 years on a well-secured drive at the University Hospital Tübingen; only the study leaders (Dr. Rosenbaum and Dr. Ehlis) are authorized to re-identify the data. The investigators would like to inform that the collected data will not be used for diagnostic purposes regarding possible pathological changes. There are no health risks associated with this study, and while it is unlikely to benefit personally from it, the participation will contribute to scientific knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in ambulant cognitive behavioral therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment as usual + Journaling
干预措施: Journaling (Behavioral)
Treatment as usual + Journaling
干预措施: Treatment as Usual (TAU) (Behavioral)
Treatment as usual
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2))
时间窗: From enrollment to the end of treatment at 24 weeks
Number of patients exhibiting reliable changes in FEP-2 scores between baseline and end of treatment. FEP-2 = Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy). Minimum = 1; Maximum = 5. Higher scores mean a better outcome.
Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy)(FEP-2))
时间窗: From enrollment to the end of treatment at 24 weeks
Number of sessions until patients exhibit reliable changes in FEP-2 scores between baseline and end of treatment. FEP-2 = Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy). Minimum = 1; Maximum = 5. Higher scores mean a better outcome.
Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2))
时间窗: From enrollment to the end of treatment at 24 weeks
Number of patients exhibiting reliable changes in FEP-2 scores between baseline and end of treatment. FEP-2 = Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy). Minimum = 1; Maximum = 5. Higher scores mean a better outcome.
Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy)(FEP-2))
时间窗: From enrollment to the end of treatment at 24 weeks
Investigation of a repeated-measures ANOVA to compare the mean FEP2 values (intent-to-treat; last observation carried forward) across different phases: baseline (sessions 1-5), early change (sessions 6-15), and late change (sessions 15-25). FEP-2 = Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy). Minimum = 1; Maximum = 5. Higher scores mean a better outcome.
次要结局
- Number of days patients completed the diary(From enrollment to the end of treatment at 24 weeks)
- Custom questionnaire: Quality of implementation of goals(From enrollment to the end of treatment at 24 weeks)
- Custom questionnaire: Quality of reflection(From enrollment to the end of treatment at 24 weeks)
- Number of days patients completed the diary(From enrollment to the end of treatment at 24 weeks)
- Custom questionnaire: Quality of implementation of goals(From enrollment to the end of treatment at 24 weeks)
- Custom questionnaire: Quality of reflection(From enrollment to the end of treatment at 24 weeks)
- Custom questionnaire: Quality and quantity of homework completion(From enrollment to the end of treatment at 24 weeks)