Feasibility of Process-based Therapy in a Naturalistic Setting
NCT Number: NCT06530888
Acronym: PBaPP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depressive Disorder|Anxiety Disorder
Interventions: OTHER: Process-based Cognitive Behavioral Therapy (PBT)|OTHER: Routine practice (r-PT)
Sponsor: Goethe University
Collaborators: Philipps University Marburg Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-04
Completion Date: 2025-09
Locations: JWGUniversity, Frankfurt am Main, Hessen, 60486, Germany

Summary:
The main objective is to explore the feasibility of Process-based Therapy in a natural mental health care setting delivered by practitioners.

Primary Outcome Measures: Credibility/expectancy questionnaire(CEQ), Treatment expectancy and credibility, minimum value= 4, maximum value= 56, higher scores mean better outcome, Assessed at pre-treatment|Patient attitude towards utility of EMA and networks Scale (PAUEN), Attitude towards utility of EMA and network models, minimum value= 8, maximum value= 40, higher scores mean better outcome, Assessed at post-treatment (week 28)|Therapist attitude towards utility of EMA and networks Scale (TAUEN), Attitude towards utility of EMA and network models, minimum value= 6, maximum value= 30, higher scores mean better outcome, Assessed at post-treatment (week 28)|Treatment Evaluation Inventory (TEI), Acceptance of treatment, minimum value= 7, maximum value= 98, higher scores mean better outcome, Assessed at post-treatment (week 28)
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 pre-treatment, at post-treatment (week 28) and at 6-month follow-up|Positive-Mental Health Scale (PMH), Psychological wellbeing, minimum value=9, maximum value=36, higher scores mean better outcome, Assessed at pre-treatment, at post-treatment (week 28) 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 pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) 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 pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) 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 outcome, Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up|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 pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) 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 pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up