Feasibility of Process-based Therapy in a Naturalistic Setting

NCT ID: NCT06530888

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-04
• Study Completion Date: 2025-09-30

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).

Conditions

Depressive Disorder; Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Process-based Cognitive Behavioral Therapy

In PBT, treatment planning is based on a dynamic network analysis of EMA data collected during the baseline phase. Therapists identify the central node, significant edges, self-loops, and feedback loops between the nodes. Using this information, interventions are selected based on empirical evidence for mechanisms of change that correspond to the network characteristics.

These interventions are framed within an evolutionary framework as the variation, selection, and retention of an adaptive mode of the central node in relation to the specific context of the problem. The change in this key variable is monitored through daily judgments based on EMA. Treatment also focuses on additional targets to establish adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled in statistical analyses.

Group Type: EXPERIMENTAL

Process-based Cognitive Behavioral Therapy (PBT)

Intervention Type: OTHER

Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.

Routine practice (r-PT)

In r-PT, as opposed to PBT, a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the factors maintaining the disorder and interventions changing them, e.g. avoidance and exposure in anxiety disorders or reduced reinforcement of activities and behavioral activation in depression. Interventions are based on common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to tailor the techniques to the individual problems of the patients. Treatment process is largely structured by personal preferences of the therapist due to experience, knowledge or recommendations of the National guidelines for the mental health problem.Concomitant medication is allowed and will be controlled in statistical analyses.

Group Type: ACTIVE_COMPARATOR

Routine practice (r-PT)

Intervention Type: OTHER

Intervention planning as usual.

Interventions

Process-based Cognitive Behavioral Therapy (PBT)

Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.

Intervention Type: OTHER

Routine practice (r-PT)

Intervention planning as usual.

Intervention Type: OTHER

Other Intervention Names

Process-based Therapy with Ecological Momentary Assessment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philipps University Marburg

OTHER

Sponsor Role: collaborator

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Ulrich Stangier

Director of the Department of Clinical Psychology and Psychotherapy and Center for Psychotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

JWGUniversity

Frankfurt am Main, Hesse, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ulrich Stangier, PhD

Role: CONTACT

stangier@psych.uni-frankfurt.de

049 1707339293

Facility Contacts

Ulrich Stangier, Prof.

Role: primary

stangier@psych.uni-frankfurt.de

+4969 79822848

Ulrich Stangier

Role: backup

stangier@psych.uni-frankfurt.de

+491707339293

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://www.psychologie.uni-frankfurt.de/140318315/PBaPP_Patienteninformation

University website

Other Identifiers

III L5 - 519/05.000.002 - 2

Identifier Type: -

Identifier Source: org_study_id