Feasibility of Process-based Therapy in a Naturalistic Setting

Not Applicable

Recruiting

• Conditions: Anxiety Disorder; Depressive Disorder

• Registration Number: NCT06530888
• Lead Sponsor: Goethe University

Brief Summary

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

Detailed Description

In the naturalistic setting of mental health care, treatment decisions of psychotherapists are often based on theories or experience related to treatment approaches. An alternative approach to treatment decision is suggested by Process-based Therapy (PBT), which emphasizes empirical and rational criteria for the selection of intervention. It utilizes ecological momentary assessment (EMA) data, incorporates feedback from dynamic network analysis, and supports interventions based on individual network models and empirical evidence from research related to change processes. Currently, there are no data on the feasibility and acceptability of PBT in practice. The present study investigates in a naturalistic setting, whether PBT can be implemented by psychotherapists in mental health care. Furthermore, the investigators explore the acceptability and efficacy of PBT as compared to psychotherapy delivered in routine practice (r-PT).

Study Timeline

• Study Start: 2023-11-04
• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-07-27
• Study First Posted: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• A primary DSM-5 diagnosis of a depressive or anxiety disorder
• 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
• Diagnose of a cluster A or B (DSM-5) personality disorder
• Pervasive developmental disorder
• Psychotic disorder
• Eating disorder
• Bipolar disorder
• Severe physical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Therapist attitude towards utility of EMA and networks Scale (TAUEN)	Assessed at post-treatment (week 28)	Attitude towards utility of EMA and network models, minimum value= 6, maximum value= 30, higher scores mean better outcome
Patient attitude towards utility of EMA and networks Scale (PAUEN)	Assessed at post-treatment (week 28)	Attitude towards utility of EMA and network models, minimum value= 8, maximum value= 40, higher scores mean better outcome
Treatment Evaluation Inventory (TEI)	Assessed at post-treatment (week 28)	Acceptance of treatment, minimum value= 7, maximum value= 98, higher scores mean better outcome
Credibility/expectancy questionnaire(CEQ)	Assessed at pre-treatment	Treatment expectancy and credibility, minimum value= 4, maximum value= 56, higher scores mean better outcome

Secondary Outcome Measures

Name	Time	Method
Euroqol-5D (EQ-5D)	Assessed at pre-treatment, at post-treatment (week 28) and at 6-month follow-up	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
Positive-Mental Health Scale (PMH)	Assessed at pre-treatment, at post-treatment (week 28) and at 6-month follow-up	Psychological wellbeing, minimum value=9, maximum value=36, higher scores mean better outcome
Depression Anxiety Stress Scale (DASS-10)	Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up	Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome
Reflective Functioning Questionnaire (RFQ-8)	Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up	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
Process-based Assessment Tool (PBAT)	Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up	Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome
Acceptance and Action Questionnaire Version 2 (AAQ-2)	Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up	Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome
Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)	Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up	Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome

Trial Locations

Locations (1)

JWGUniversity; 🇩🇪 Frankfurt am Main, Hessen, Germany