Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression

Not Applicable

Recruiting

• Conditions: Depression; Anxiety Disorder

• Registration Number: NCT06517589
• Lead Sponsor: Goethe University

Brief 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.

Detailed Description

Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators have translated a Training Manual of PBT and modified for delivery of CBT in Mental Health Service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.

Study Timeline

• Study Start: 2024-01-29
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scale (DASS-21)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up	Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome

Secondary Outcome Measures

Name	Time	Method
Reflective Functioning Questionnaire (RFQ-8)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) 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 outcomes
Acceptance and Action Questionnaire Version 2 (AAQ-2)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up	Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome
Positive-Mental Health Scale (PMH)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up	Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome
Depression Anxiety Stress Scale (DASS-10)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) 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
Euroqol-5D (EQ-5D)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) 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
Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up	Pleasure in interpersonal situations, minimum value=17, maximum value=102, higher scores mean better outcome
Client Satisfaction Questionnaire (CSQ-8)	Assessed at post-treatment at week 32	Client Satisfaction, minimum value=8, maximum value=32, higher scores mean better outcome
Process-based Assessment Tool (PBAT)	Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up	Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome
Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)	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	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