Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy

Официальное название

Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy: A Randomized Controlled Trial

Обзор

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, psychotherapy patients will be randomly assigned to two treatment groups: CBT vs. CBT + Journaling. Patients will be block-randomized until 40 patients have completed the study in each treatment arm (at least 10 completed sessions).

Подробное описание

As part of this study, the investigators are examining the effectiveness of certain therapeutic techniques that could improve the effectiveness of psychotherapy. Patients will be assigned to one of two treatment groups: one group will receive standard treatment, while the second group will receive additional tasks/techniques. Patients will be block-randomized until 40 patients have completed the study in each treatment arm (at least 10 completed sessions). 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.

Вмешательства

• Поведенческое Journaling
  In the journaling condition, participants will be asked to keep a therapy journal twice a day in addition to the content of the cognitve behavioral therapy. At the beginning of the day, patients are to set a daily goal that aligns with their therapy goals (e.g., remaining calm when negative thoughts arise), and at the end of the day, they will reflect on the day itself and the work done on their therapy goals.
• Поведенческое Treatment as Usual (TAU)
  Patients in this arm receive standard treatment (cognitive behavioral therapy) for their individual diagnosis. The study participation spans a period of 24 sessions (short-term psychotherapy KZT1\&2), during which the severity of 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)

Первичные конечные точки

• Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2)) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy)(FEP-2)) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy)(FEP-2)) [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy)(FEP-2)) [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Вторичные конечные точки (4)

• Number of days patients completed the diary [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Custom questionnaire: Quality of implementation of goals [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Custom questionnaire: Quality of reflection [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Custom questionnaire: Quality and quantity of homework completion [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Критерии участия

Критерии включения

• patients in ambulant cognitive behavioral therapy

Критерии исключения

• none

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Hospital Tübingen, Department of Psychiatry and Psychotherapy — Tübingen

Идентификаторы

NCT: NCT06863909 · 611/2024BO2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗