Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Journaling, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Affective Disorders, Rumination, Childhood Trauma, Eating Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy: A Randomized Controlled Trial
Overview
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).
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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)
Primary outcome measures
- Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2)) [Time frame: 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)) [Time frame: 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)) [Time frame: 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)) [Time frame: From enrollment to the end of treatment at 24 weeks]
Secondary outcome measures (4)
- Number of days patients completed the diary [Time frame: From enrollment to the end of treatment at 24 weeks]
- Custom questionnaire: Quality of implementation of goals [Time frame: From enrollment to the end of treatment at 24 weeks]
- Custom questionnaire: Quality of reflection [Time frame: From enrollment to the end of treatment at 24 weeks]
- Custom questionnaire: Quality and quantity of homework completion [Time frame: From enrollment to the end of treatment at 24 weeks]
Eligibility criteria
Inclusion criteria
- patients in ambulant cognitive behavioral therapy
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Hospital Tübingen, Department of Psychiatry and Psychotherapy — Tübingen
Identifiers
NCT: NCT06863909 · 611/2024BO2