Feasibility of Process-based Therapy in a Naturalistic Setting
- Conditions
- Anxiety DisorderDepressive Disorder
- Interventions
- Other: Routine practice (r-PT)Other: Process-based Cognitive Behavioral Therapy (PBT)
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Arm && Interventions
Group Intervention Description Routine practice (r-PT) 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. Process-based Cognitive Behavioral Therapy Process-based Cognitive Behavioral Therapy (PBT) 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.
- 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