Clinical trial NCT06863909: Study on the Effectiveness of Journaling As an Add-on to Cognitive Behavioral Therapy
Official title: Study on the Effectiveness of Journaling As an Add-on to Cognitive Behavioral Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Affective Disorders
Rumination
Childhood Trauma
Eating Disorder
Substance Use Disorder
Personality Disorder
Mental Disorder
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 80 patients will be included, 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients in ambulant cognitive behavioral therapy

Exclusion Criteria:

* none

Primary outcomes:
measure: Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2))
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy)(FEP-2))
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
measure: Number of days patients completed the diary
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Custom questionnaire: Quality of implementation of goals
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Custom questionnaire: Quality of reflection
timeFrame: From enrollment to the end of treatment at 24 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Psychiatry and Psychotherapy
Study officials:
affiliation: University Hospital Tübingen Department of Psychiatry and Psychotherapy
name: Ann-Christine Ehlis, Dr.
role: PRINCIPAL_INVESTIGATOR
References: