Efficacy and Safety of a Brief Transdiagnostic Cognitive Behavioral Intervention: A Randomized Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037856

Enrollment

Registered

2025-09-18

Start date

2025-07-07

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32.0 F32.1 F32.2 F33.0 F33.1 F33.2 F34.1 F40.0 F40.1 F41.0 F41.1

Interventions

Group 1: Intervention group: Patients, who will be allocated to the intervention group, receive the five session (each 100 minutes) brief transdiagnostig cognitiv-behavioral intervention within 5 week

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - fluent in spoken and written German - the presence of one of the following ICD-10 diagnosis: F32, F33, F34.1, F40 (exclusion: F40.2, specific phobia), F41

Exclusion criteria

Exclusion criteria: - current psychotherapeutic treatment - regular use of benzodiazepines - change in psychopharmacological medication less than 4 weeks ago - acute suicidality - current addiction disorder (alcohol and/or drugs) - current psychosis - current (hypo)mania (ICD-10: F30) or bipolar affective dirsorder (ICD-10: F31) - current pregnany or breastfeeding period

Design outcomes

Primary

Measure	Time frame
Symtom Distress (Brief-Symptom-Iventary-18) at Post-Treatment (T2). Additionally, Symtom Distress will be measured at 2-months follow-up after the last intervention session.	—

Secondary

Measure	Time frame
- Depressive Symptoms (Patient Health Questionnaire-9 (PHQ-9)) - Anxiety Symptoms (Beck-Angst-Inventar (BAI)) - Emotion Regulation (Emotion Regulation Questionnaire (ERQ)) - Emotional Avoidance (Brief Behavioral Experiential Avoidance Questionnaire (BEAQ)) - Negative Affectivity (Subscale "negative affectivity" of the Persönlichkeitsinventar für DSM-5 und ICD-11- Short Version (ICDPID5BF+)) - Mindfulness (Southampton Mindfulness Questionnaire (SMQ-D)) - Self-Esteem (Rosenberg-Self-Esteem-Skala (RSES)) - Internalized Stigma (Internalized Stigma of Menal Illness Skala (ISMI)) - Social Distance (soziale Distanzskala) - Group Psychotherapy Motivation (Fragebogen zur Erfassung der Gruppenpsychotherapiemotivation (FGPTM)) All assessments take place at baseline (T1), one week after the last intervention session (T2), and at 2-months follow-up (T3). Additionally, sociodemographics and childhood maltreatment (CTQ) will be assessed at baseline (T1). At post-intervention (T2), intervention satisfaction (ZUF-8), and adverse events (INEP) will be assessed.	—

Measure

Time frame

- Depressive Symptoms (Patient Health Questionnaire-9 (PHQ-9)) - Anxiety Symptoms (Beck-Angst-Inventar (BAI)) - Emotion Regulation (Emotion Regulation Questionnaire (ERQ)) - Emotional Avoidance (Brief Behavioral Experiential Avoidance Questionnaire (BEAQ)) - Negative Affectivity (Subscale "negative affectivity" of the Persönlichkeitsinventar für DSM-5 und ICD-11- Short Version (ICDPID5BF+)) - Mindfulness (Southampton Mindfulness Questionnaire (SMQ-D)) - Self-Esteem (Rosenberg-Self-Esteem-Skala (RSES)) - Internalized Stigma (Internalized Stigma of Menal Illness Skala (ISMI)) - Social Distance (soziale Distanzskala) - Group Psychotherapy Motivation (Fragebogen zur Erfassung der Gruppenpsychotherapiemotivation (FGPTM)) All assessments take place at baseline (T1), one week after the last intervention session (T2), and at 2-months follow-up (T3). Additionally, sociodemographics and childhood maltreatment (CTQ) will be assessed at baseline (T1). At post-intervention (T2), intervention satisfaction (ZUF-8), and adverse events (INEP) will be assessed.

—

Countries

Germany

Contacts

Public ContactJulia Bosch

Universitätsklinikum Ulm, Klinik für Psychiatrie und Psychotherapie III

julia.bosch@uniklinik-ulm.de+49 500 62072

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026