Clinical trial NCT06530888: Feasibility of Process-based Therapy in a Naturalistic Setting
Official title: Feasibility of Process-based Therapy in a Naturalistic Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorder
Keywords: feasibility
Process-based Therapy
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
First posted: 2024-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Credibility/expectancy questionnaire(CEQ)
timeFrame: Assessed at pre-treatment
measure: Patient attitude towards utility of EMA and networks Scale (PAUEN)
timeFrame: Assessed at post-treatment (week 28)
measure: Therapist attitude towards utility of EMA and networks Scale (TAUEN)
timeFrame: Assessed at post-treatment (week 28)
measure: Treatment Evaluation Inventory (TEI)
timeFrame: Assessed at post-treatment (week 28)
Secondary outcomes:
measure: Euroqol-5D (EQ-5D)
timeFrame: Assessed at pre-treatment, at post-treatment (week 28) and at 6-month follow-up
measure: Positive-Mental Health Scale (PMH)
timeFrame: Assessed at pre-treatment, at post-treatment (week 28) and at 6-month follow-up
measure: Depression Anxiety Stress Scale (DASS-10)
timeFrame: Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up
measure: Acceptance and Action Questionnaire Version 2 (AAQ-2)
timeFrame: Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up
measure: Reflective Functioning Questionnaire (RFQ-8)
timeFrame: Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up
measure: Process-based Assessment Tool (PBAT)
timeFrame: Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up
measure: Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)
timeFrame: Assessed at pre-treatment, at intermediate treatment (week 8), at post-treatment (week 28) and at 6-month follow-up
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: JWGUniversity
state: Hessen
Study officials:
References: