Feasibility of Process-based Therapy in a Naturalistic Setting

NCT06530888 | Active Not Recruiting

• 1 other identifier: III L5 - 519/05.000.002 - 2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Disorder; Anxiety Disorder

Keywords

feasibility; Process-based Therapy

Outcome Measures

Primary Outcomes (5)

• Client Satisfaction Questionnaire (CSQ)

  Treatment satisfaction , minimum value= 8, maximum value= 32, higher scores mean better outcome

  From the time of randomization until the end of treatment, assessed no later than 28 weeks

• 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

  From the time of randomization until the end of treatment, assessed no later than 28 weeks

• 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

  From the time of randomization until the end of treatment, assessed no later than 28 weeks

• Treatment Evaluation Inventory (TEI)

  Acceptance of treatment, minimum value= 7, maximum value= 98, higher scores mean better outcome

  From the time of randomization until the end of treatment, assessed no later than 28 weeks

• Attrition rate

  The percentage of participants who withdraw before completing the final assessment

  From the time of randomization until the end of treatment, assessed no later than 28 weeks

Secondary Outcomes (9)

• Euroqol-5D (EQ-5D)

  Assessed after randomization and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment

• Positive-Mental Health Scale (PMH)

  Assessed after randomization and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment

• Depression Anxiety Stress Scale (DASS-10)

  Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment (week 28)

• Acceptance and Action Questionnaire Version 2 (AAQ-2)

  Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment

• Reflective Functioning Questionnaire (RFQ-8)

  Assessed after randomization, after completion of the EMA baseline phase (intermediate) and assessed until the end of treatment, assessed no later than 28 weeks at post-treatment

Study Arms (2)

Process-based Cognitive Behavioral Therapy

EXPERIMENTAL

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.

Other: Process-based Cognitive Behavioral Therapy (PBT)

Routine practice (r-PT)

ACTIVE COMPARATOR

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.

Other: Routine practice (r-PT)

Interventions

Routine practice (r-PT) OTHER

Intervention planning as usual.

Routine practice (r-PT)

Process-based Cognitive Behavioral Therapy (PBT) 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.

Also known as: Process-based Therapy with Ecological Momentary Assessment

Process-based Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead
• Philipps University Marburg: collaborator

Study Sites (1)

JWGUniversity

Frankfurt am Main, Hesse, 60486, Germany

Location

Related Links

• University website

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Clinical Psychology and Psychotherapy and Center for Psychotherapy

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: November 4, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication. Data are available for 5 years at a third-party website (Link to be included).
• Access Criteria: Proposals should be directed to stangier@psych.uni-frankfurt.de. To gain access, data requestors will need to sign a data access agreement.

Locations

DE (1)