Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making

Official title

Process Based Therapy Applicability, Effectiveness and Compatibility (PBACE). A Within Therapist Randomized Controlled Trial Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making

Overview

Background: Process Based Therapy (PBT) is a novel approach for a more personalized psychotherapy by integrating patient's ecological momentary assessment (EMA) data into treatment planning and focusing on empirically measured maladaptive processes. Previous pilot studies have examined the efficacy and feasibility of PBT in different settings. However, the effectiveness of this approach as well as the influence of providing EMA data on therapist's decision-making as well as treatment planning is yet unexplored. Objective: This study aims to evaluate the effectiveness of PBT in a naturalistic setting as well examine the influence of the provision of EMA data on therapists' decision-making. Methods: Thiry therapists as well as 60 patients will be recruited. Therapists will each treat two patients which are randomly allocated to either an intervention group receiving PBT or an active control group receiving routine psychotherapy. Treatment outcomes will be measured pre and post treatment as well as a 6-month follow-up. Therapists' decision making will be measured before training in PBT as well as during the treatment process using think aloud protocols (TAP) as well as quantitative measurements for decision making styles and self efficacy in decision making. Discussion: This study could add insights into the ongoing research about the efficacy and effectiveness of PBT as well as provide insights into therapists' treatment decisions. While PBT holds theoretical promise for a more personalized and effective treatment, empirical data is still needed to assess its theoretical merit, which this study could provide. Expanding on the thus far scarce literature on decision-making in the therapeutic process, valuable information about processes guiding therapists' treatment decisions could be gained.

Interventions

• Other Process Based Psychotherapy (PBT)
  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 Routine practice
  Intervention planning as usual.
• Drug Psychiatric medication kept constant over study duration
  Psychiatric medication is kept constant during the trial. Participants are not required to take medication. If participants enlisting in the trial are on medication however, they will be asked to keep medication constant over the study duration

Primary outcome measures

• Depressive and anxiety symptom severity [Time frame: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.]
• Positive Mental Health and Quality of Life [Time frame: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.]
• Therapist Decision Making [Time frame: Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22).]

Secondary outcome measures (7)

• Client satisfaction [Time frame: Assessed at post-treatment (week 28).]
• Patient and Therapist Attitude Towards EMA-Assessment [Time frame: Assessed at intermediate (week 6) and post-treatment (week 28) (PAUEN). Assessed at intermediate (week 6) and every four weeks in Treatment Phase (Weeks 10, 14, 18 and 22) (TAUEN)]
• Therapist Treatment Evaluation [Time frame: Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).]
• Self-Efficacy [Time frame: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.]
• Decisional Self-Efficacy [Time frame: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up.]
• Therapeutic Alliance [Time frame: Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).]
• Therapist Decision Making Style [Time frame: Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22).]

Eligibility criteria

Inclusion criteria

• A primary ICD-11 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
• diagnosis of a cluster A or B (DSM-5) personality disorder
• pervasive developmental disorder, psychotic disorder, eating disorder, bipolar disorder, or severe physical illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• JWGUniversity — Frankfurt am Main

Publications

• Wilmers, F., & Munder, T. (2016). Der WAI-sr. In K. Geue, B. Strauß, & E. Brähler (Hrsg.), Diagnostische Verfahren in der Psychotherapie (3. Aufl.). Hogrefe.
• Someren, M. W. van, Barnard, Y. F., & Sandberg, J. A. (1994). The think aloud method: A practical guide to modelling cognitive processes. Academic Press.
• Schwarzer, R., & Jerusalem, M. (2012). General Self-Efficacy Scale [Dataset]. https://doi.org/10.1037/t00393-000
• Lukat, J., Margraf, J., Lutz, R., Van Der Veld, W. M., & Becker, E. S. (2019). Positive Mental Health Scale [Dataset]. https://doi.org/10.1037/t74178-000
• Lovibond, S. H., & Lovibond, P. F. (2011). Depression Anxiety Stress Scales [Dataset]. https://doi.org/10.1037/t01004-000
• Frumkin MR, Piccirillo ML, Beck ED, Grossman JT, Rodebaugh TL. Feasibility and utility of idiographic models in the clinic: A pilot study. Psychother Res. 2021 Apr;31(4):520-534. doi: 10.1080/10503307.2020.1805133. Epub 2020 Aug 24. PMID 32838671
• Fiehn, H. (n.d.). The Therapist Decision Making Style Questionnaire. [Manuscript in preparation].
• Burgio LD, Sinnott J. Behavioral treatments and pharmacotherapy: acceptability ratings by elderly individuals in residential settings. Gerontologist. 1990 Dec;30(6):811-6. doi: 10.1093/geront/30.6.811. PMID 2286341

Identifiers

NCT: NCT07704138 · 2026-00-PBACE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗