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Pilotstudy on Process-Based Therapy in Difficult to Treat Depression and Anxiety Disorder

Pilotstudy on Process-Based Therapy in Difficult to Treat Depression and Anxiety Disorder - PBTRAND

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032863
Enrollment
40
Registered
2025-04-30
Start date
2024-01-15
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

F32 F33 F34.1 F40 F41

Interventions

Group 1: Intervention (Process-based cognitive behavioral therapy: PB-CBT) Baseline Phase: In the PB-CBT condition, a hypothetical maladaptive disorder model is derived based on each patient’s indiv

Sponsors

Phillips-Universität
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients will be recruited from the adult outpatient department of the Center for Psychotherapy at Goethe University. Only patients who have previously signaled their interest in participating in the research will be informed about the study. After a detailed explanation of the study, the patients are willing to participate in outpatient psychotherapy at the Center for Psychotherapy once a week for a period of 24 weeks. They fulfill the criteria of a depressive disorder or an anxiety disorder. On the basis of these criteria, the patients have already undergone at least one guideline-oriented psychotherapy and at least one guideline-oriented psychopharmacotherapy. At the beginning of the study, they are either not receiving any psychopharmaceuticals or their medication has been constant for at least 4 weeks.

Exclusion criteria

Exclusion criteria: Current psychotherapeutic treatment, substance dependence, posttraumatic stress disorder, bipolar disorder I (lifetime), psychotic disorder (lifetime), borderline type emotionally unstable personality disorder, brain organic disorders, acute suicidality, suicide attempt in the past 6 months, serious medical circumstances precluding psychotherapy, medication changes in the 4 weeks before study participation, or mental disorders requiring treatment in a different setting (eg, BMI<16.5).

Design outcomes

Primary

MeasureTime frame
Change of positive mental health score (PMH) after the intervention ended (T1) and 6 months after the intervention ended (T2)

Secondary

MeasureTime frame
Change in depression and anxiety symptoms, quality of life, well-being, acceptance, ability to reflect and functional inner processes after the intervention (T1), as well as 6 months after the intervention (T2) Additional exploratory analyses are conducted using a partial data set that includes measurements taken at baseline and after the self-observation phase. These analyses are conducted before the start of the therapeutic intervention and serve to investigate the effects of self-observation (diary vs. Ecological Momentary Assessment, EMA) on the psychological variables already mentioned, as well as variables that indicate acceptance (response behavior over time, number of missing values, and dropout rate).

Countries

Germany

Contacts

Public ContactUlrich Stangier

Goethe-Universität

stangier@psych.uni-frankfurt.de+49 69 7982 2848

Outcome results

None listed

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