Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06530888

Feasibility of Process-based Therapy in a Naturalistic Setting

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depressive Disorder Anxiety Disorder Anxiety Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JWGUniversity

Frankfurt am Main, Hesse, 60486, Germany

About this study

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 first indications of efficacy of PBT delivered in routine practice (r-PT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Process-based Therapy with Ecological Momentary Assessment

Routine practice (r-PT)

Other

Intervention planning as usual.

Primary outcomes

  1. Client Satisfaction Questionnaire (CSQ)

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

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

  2. Patient attitude towards utility of EMA and networks Scale (PAUEN)

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

    Attitude towards utility of EMA and network models, minimum value= 8, maximum value= 40, higher scores mean better outcome

  3. Therapist attitude towards utility of EMA and networks Scale (TAUEN)

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

    Attitude towards utility of EMA and network models, minimum value= 6, maximum value= 30, higher scores mean better outcome

  4. Treatment Evaluation Inventory (TEI)

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

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

  5. Attrition rate

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

    The percentage of participants who withdraw before completing the final assessment

Secondary outcomes

  1. Euroqol-5D (EQ-5D)

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

    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

  2. Positive-Mental Health Scale (PMH)

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

    Psychological wellbeing, minimum value=9, maximum value=36, higher scores mean better outcome

  3. Depression Anxiety Stress Scale (DASS-10)

    Time frame: 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)

    Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome

  4. Acceptance and Action Questionnaire Version 2 (AAQ-2)

    Time frame: 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

    Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome

  5. Reflective Functioning Questionnaire (RFQ-8)

    Time frame: 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, minimum value=8, maximum value=56, higher scores on the uncertainty dimension mean worse outcome, higher scores in the certainty dimension mean better outcome

  6. Process-based Assessment Tool (PBAT)

    Time frame: 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

    Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome

  7. Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)

    Time frame: 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

    Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome

  8. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Assessed after randomization (pre-treatment)

    six items, divided into two subscales that capture credibility and expectancy

  9. Clinical Global Impression Scale (CGI) + (CGI-I)

    Time frame: CGI assessed after randomization (pre-treatment), CGI-I assessed until the end of treatment, assessed no later than 28 weeks at post-treatment

    assesses the clinician's overall evaluation of the severity of a mental disorder and is utilized to monitor changes in symptom severity over time

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Philipps University Marburg

Registry information

Acronym: PBaPP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.