New therapy for hard-to-treat anxiety and depression
Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression
This study is testing a new therapy called Process-based Therapy to see if it helps people with hard-to-treat anxiety and depression better than traditional therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Goethe University Academic / other |
| Locations | 1 site (Frankfurt am Main, Hesse) |
| Trial ID | NCT06517589 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Process-based Therapy (PBT) compared to traditional Cognitive Behavioral Therapy (CBT) for patients with difficult-to-treat anxiety disorders and depression. PBT utilizes ecological momentary assessment data and dynamic network analysis to tailor interventions to the individual needs of patients. The study will involve participants who have previously not responded to standard treatments, assessing the feasibility and effectiveness of this innovative approach in a larger clinical sample.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a primary diagnosis of anxiety or depressive disorders who have not responded to at least two previous treatment attempts.
Not a fit: Patients with severe mental health issues such as increased suicidality, substance abuse, or certain personality disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with challenging anxiety and depression conditions.
How similar studies have performed: Preliminary support for Process-based Therapy has been reported, but this study represents a novel approach with no extensive prior data on its effectiveness in larger populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A primary DSM-5 diagnosis of depressive or anxiety disorder * At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) * Age 18-65 years * Sufficient knowledge of the German language * Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period Exclusion Criteria: * Increased suicidality * Substance abuse or dependency * Borderline personality disorder * Pervasive developmental disorder * Psychotic disorder * Eating disorder * Bipolar disorder * Severe physical illness
Where this trial is running
Frankfurt am Main, Hesse
- JWGUniversity — Frankfurt am Main, Hesse, Germany (Recruiting)
Study contacts
- Study coordinator: Ulrich Stangier, PhD
- Email: stangier@psych.uni-frankfurt.de
- Phone: 049 1707339293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.