Anxiety Disorder, Depressive Disorder
Conditions
Keywords
feasibility, Process-based Therapy
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 first indications of efficacy of PBT delivered in routine practice (r-PT).
Interventions
Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
OTHERRoutine practice (r-PT)
Intervention planning as usual.
Sponsors
Goethe University
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Evaluation Inventory (TEI) | 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 |
| Attrition rate | 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 |
| Client Satisfaction Questionnaire (CSQ) | 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 |
| Patient attitude towards utility of EMA and networks Scale (PAUEN) | 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 |
| Therapist attitude towards utility of EMA and networks Scale (TAUEN) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 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 |
| Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ) | 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 |
| Credibility/Expectancy Questionnaire (CEQ) | Assessed after randomization (pre-treatment) | six items, divided into two subscales that capture credibility and expectancy |
| Clinical Global Impression Scale (CGI) + (CGI-I) | 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 |
| Euroqol-5D (EQ-5D) | 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 |
| Positive-Mental Health Scale (PMH) | 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 |
| 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) | Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome |
| 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 | Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome |
Countries
Germany
Outcome results
None listed