Affective DisordersNCT06863909
Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy
A study testing Journaling and Treatment as Usual (TAU) in people with Affective Disorders and Rumination, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Affective Disorders, Rumination, Childhood Trauma
- What is being tested?
- Journaling and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in ambulant cognitive behavioral therapy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, 72076
About this study
Official title: Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy: A Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Affective Disorders, Rumination, Childhood Trauma, Eating Disorder, Substance Use Disorder, Personality Disorder
- Being tested
- Journaling, Treatment as Usual (TAU)
- Medical subject headings
- Mood Disorders, Rumination Syndrome, Feeding and Eating Disorders, Substance-Related Disorders, Personality Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JournalingBehavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Not described Receives: Behavioral: Treatment as Usual (TAU) |
| Treatment as usual + Journaling | Experimental | Not described Receives: Behavioral: Journaling; Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire for the Evaluation of Psychotherapy Progress (german: Fragebogen zur Evaluation von Psychotherapieverläufen (english translation: Questionnaire for evaluating the course of psychotherapy) (FEP-2))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: 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))
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.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (4)
Number of days patients completed the diary
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.
Measured: From enrollment to the end of treatment at 24 weeks
Custom questionnaire: Quality of implementation of goals
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.
Measured: From enrollment to the end of treatment at 24 weeks
Custom questionnaire: Quality of reflection
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.
Measured: From enrollment to the end of treatment at 24 weeks
Custom questionnaire: Quality and quantity of homework completion
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.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann-Christine Ehlis, Dr., Principal investigator, University Hospital Tübingen Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863909
- Sponsor's protocol ID
- 611/2024BO2
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06863909
- Acronym / sponsor ID
- 611/2024BO2
- Conditions
- Affective Disorders, Rumination, Childhood Trauma, Eating Disorder, Substance Use Disorder, Personality Disorder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as Usual (TAU) |
| Treatment as usual + Journaling | Experimental | Behavioral: Journaling, Behavioral: Treatment as Usual (TAU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients in ambulant cognitive behavioral therapy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JournalingIn 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. | Behavioural | Treatment as usual + Journaling |
| 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). | Behavioural | Treatment as usual, Treatment as usual + Journaling |
Primary 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))
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.
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.
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann-Christine Ehlis, Dr. principal investigator
University Hospital Tübingen Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Journaling and Treatment as Usual (TAU) in people with Affective Disorders and Rumination, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)) (time frame: From enrollment to the end of treatment at 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.