Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression
NCT Number: NCT06517589
Acronym: PBTRAND
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anxiety Disorder
Interventions: OTHER: Process-based Cognitive Behavioral Therapy (PBT)|OTHER: Cognitive Behavioral Therapy (CBT)
Sponsor: Goethe University
Collaborators: Philipps University Marburg Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-29
Completion Date: 2025-07-30
Locations: JWGUniversity, Frankfurt am Main, Hessen, 60486, Germany

Summary:
The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.

Primary Outcome Measures: Depression Anxiety Stress Scale (DASS-21), Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Secondary Outcome Measures: Euroqol-5D (EQ-5D), Health related quality of life, minimum health state=11111, maximum health state=55555, higher scores in health state mean worse outcome, minimum health score=0, maximum health score=100, higher scores in health score mean better outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Positive-Mental Health Scale (PMH), Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS), Pleasure in interpersonal situations, minimum value=17, maximum value=102, higher scores mean better outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Depression Anxiety Stress Scale (DASS-10), Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Acceptance and Action Questionnaire Version 2 (AAQ-2), Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Reflective Functioning Questionnaire (RFQ-8), Reflective Functioning, minimum value=8, maximum value=56, higher scores on the uncertainty dimension mean worse outcome, higher scores in the certainty dimension mean better outcomes, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Client Satisfaction Questionnaire (CSQ-8), Client Satisfaction, minimum value=8, maximum value=32, higher scores mean better outcome, Assessed at post-treatment at week 32|Process-based Assessment Tool (PBAT), Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome, Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up|Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ), Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome, Assessed at inclusion, pre-treatment, weekly during the treatment (from week 11 to 30), at post-treatment (week 32) and at 6 month follow-up