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NCT Number: NCT07704138

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

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.

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Key information

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

Location status: Recruiting

Location contact

Ulrich Stangier Research Professor, PhD

CONTACT

[email protected]

+491707339293

Ulrich Stangier, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Process Based Psychotherapy (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

Other

Intervention planning as usual.

Other names: Routine psychotherapy

Psychiatric medication kept constant over study duration

Drug

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 outcomes

  1. 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.

    To assess Psychopathological Stress , the Depression Anxiety Stress Scale 21 (DASS-21) is used. The DASS-21 is a validated and reliable 21 item self-report instrument for the measurement of depressive and anxiety symptoms. Additionally, stress as a negative affective state is measured on an additional subscale. The scale ranges from 1-4 with higher mean values reflecting higher symptom severity in the respective subscale as well as an overall score of Psychopathological Stress.

  2. 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.

    Positive mental health and quality of Life will be measured using the positive mental health scale (PMH). The PMH is a validated nine-item self-report scale for the measurement of the presence of positive mental health. Scores range form 1-4 with higher mean scores reflecting a more positive mental health.

  3. 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).

    Therapist Decision Making regarding treatment planning will be measured using think-aloud protocols (TAP). The think-aloud method is usually used to measure decision making in cognitive tasks such as problem solving, where participants are instructed to "think-aloud" meaning to verbalize their thoughts during a cognitive task. In this study, therapists will be instructed to verbalize their treatment planning at nine measurement points.

Secondary outcomes

  1. Client satisfaction

    Time frame: Assessed at post-treatment (week 28).

    Patient satisfaction at the end of treatment, measured with the Client Satisfaction Questionnaire (CSQ). The CSQ uses 8 items with a range of 1-4 with higher mean values reflecting higher satisfaction with the recieved treatment.

  2. 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)

    the therapist attitudes toward the utility of the EMA and networks scale (TAUEN) and the patient attitudes toward the utility of the EMA and networks scale (PAUEN) are modified versions of the Therapist and Client Attitudes Measures. minimum value= 8, maximum value= 40, higher scores mean a higher attitude toward EMA and networks regarding their utility.

  3. Therapist Treatment Evaluation

    Time frame: Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).

    The Treatment Evaluation Inventory will be used to assess therapists' perceptions of treatment. It consists of 14 statements that are evaluated on a 7-point Likert scale, with response options spanning from -3 (strongly disagree) to +3 (strongly agree). A higher mean score reflects a higher attitude towards the given treatment (e.g. PBT or routine care)

  4. 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.

    Perceived general self-efficacy, meaning an optimistic self-belief that one can perform difficult or novel tasks or cope with adversity is measured by the General Self-Efficacy Scale (GSE). The GSE is a 10-item self-report questionnaire with a validated one factor structure. The GSE ranges from 1-4 with a higher mean score reflecting higher self-efficacy.

  5. 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.

    Decision making self-efficacy is measured using the Decision Self-Efficacy Scale. The DSE is an 11-item self-report instrument measuring self-efficacy in the domain of treatment decisions. The DSE ranges from 0-4 with higher mean scores reflecting a higher confidence and self-efficacy in treatment decisions.

  6. 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).

    Therapeutic Alliance is measured at patient level using the Working Alliance Inventory Short Revised Patient Version (WAI-SR-P). The WAI-SR-P measures therapeutic alliance from the patient's perspective using 12 items as a self report ranging from 1-5 with higher mean scores reflecting a stronger and more positive working alliance as perceived by the patient.

  7. 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).

    Therapists' Decision Making Styles will be measured using the therapist decision making questionnaire (TDMQ). The TDMQ is a self-report scale measuring therapists' decision-making style using 23 items on a scale from 1 to 5. Higher mean scores on a specific subscale reflect a decision style that puts a higher emphasis on the sources of information belonging to that specific decision making style.

Study contacts

Contact information is provided by the study sponsor or research team.

Ulrich Stangier, PhD

CONTACT

[email protected]

049 1707339293

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study 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

Acronym: PBACE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 15, 2026
Registry last updated
Jul 15, 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.

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