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NCT Number: NCT06863909

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

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).

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Key information

Conditions

Affective Disorders Chemically-Induced Disorders Childhood Trauma Digestive System Diseases Eating Disorder Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorder Mental Disorders Mood Disorders Pathological Conditions, Signs and Symptoms Personality Disorder Personality Disorders Rumination Rumination Syndrome Signs and Symptoms Signs and Symptoms, Digestive Substance Use Disorder Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients in ambulant cognitive behavioral therapy

Exclusion criteria

  • none

Treatment and study plan

Journaling

Behavioral

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.

Treatment as Usual (TAU)

Behavioral

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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    Investigation of the changes in FEP-2 scores between the groups 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.

  4. 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

    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.

Secondary outcomes

  1. Number of days patients completed the diary

    Time frame: From enrollment to the end of treatment at 24 weeks

    At the end of each therapy session, the therapist assesses the frequency with which the diary was completed as an indicator of the complicance of the patient.

    The "frequency of completion" is measured in the number of days in which the diary was completed (e.g. diary was completed on 5 days = 5). The maximum of the scale is calculated by the number of days that have passed since the last session. Higher scores mean a better outcome.

  2. Custom questionnaire: Quality of implementation of goals

    Time frame: From enrollment to the end of treatment at 24 weeks

    At the end of each therapy session, the therapist rates the quality of the implementation of the goals as an indicator of the compliance of the patient.

    The scale "Quality of implementation of goals" is measured on a custom 5-point Likert scale. The therapist rates:

    • = did not implement the rules of goal setting on any day
    • = implemented the rules of goal setting on less than half of the days, but not never
    • = implemented the rules of goal setting on half of the days
    • = implemented the rules of goal setting on more than half of the days, but not always
    • = implemented the rules of goal setting every day The minimum is correspondingly 1, the maximum 5. Higher scores mean a better outcome.

  3. Custom questionnaire: Quality of reflection

    Time frame: From enrollment to the end of treatment at 24 weeks

    At the end of each therapy session, the therapist rates the quality of the reflection as an indicator of the compliance of the patient.

    The scale "Quality of reflection" is measured on a custom 5-point Likert scale. The therapist rates:

    • = not reflected on any day if necessary
    • = reflected on less than half of the days, but not never, if necessary
    • = reflected on half of the days if necessary
    • = reflected on more than half of the days, but not always, if necessary
    • = reflected on every day if necessary The minimum is correspondingly 1, the maximum 5. Higher scores mean a better outcome.

  4. Custom questionnaire: Quality and quantity of homework completion

    Time frame: From enrollment to the end of treatment at 24 weeks

    At the end of each therapy session, the therapist rates the quality of the overall quality and quantity of the homework completion.

    This scale is measured on a custom 5-point Likert scale. The therapist rates:

    • = not at all
    • = a little
    • = moderate
    • = good
    • = very good The minimum is correspondingly 1, the maximum 5. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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