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

NCT06863909 | Enrolling By Invitation

• 1 other identifier: 611/2024BO2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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, 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).

Conditions

Affective Disorders; Rumination; Childhood Trauma; Eating Disorder; Substance Use Disorder; Personality Disorder; Mental Disorder

Outcome Measures

Primary Outcomes (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))

  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.

  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.

  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.

  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.

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (4)

• Number of days patients completed the diary

  From enrollment to the end of treatment at 24 weeks

• Custom questionnaire: Quality of implementation of goals

  From enrollment to the end of treatment at 24 weeks

• Custom questionnaire: Quality of reflection

  From enrollment to the end of treatment at 24 weeks

• Custom questionnaire: Quality and quantity of homework completion

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Behavioral: Treatment as Usual (TAU)

Treatment as usual + Journaling

EXPERIMENTAL

Behavioral: Journaling; Behavioral: Treatment as Usual (TAU)

Interventions

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 + Journaling

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).

Treatment as usual; Treatment as usual + Journaling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in ambulant cognitive behavioral therapy

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Mood Disorders; Rumination Syndrome; Feeding and Eating Disorders; Substance-Related Disorders; Personality Disorders; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Ann-Christine Ehlis, Dr.

  University Hospital Tübingen Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 7, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

DE (1)