Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making (PBACE)
2026年7月9日 更新者：Prof. Dr. Ulrich Stangier、Goethe University
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
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.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ulrich Stangier, PhD
- 電話番号：049 1707339293
- メール：stangier@psych.uni-frankfurt.de
研究場所
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Hesse
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Frankfurt am Main、Hesse、ドイツ、60486
- 募集
- JWGUniversity
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コンタクト：
- Ulrich Stangier Research Professor, PhD
- 電話番号：+491707339293
- メール：stangier@psych.uni-frankfurt.de
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主任研究者：
- Ulrich Stangier, PhD
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Process Based Psychotherapy (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 by the study design.
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Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
他の名前：
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
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アクティブコンパレータ：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 by the study design.
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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
Intervention planning as usual.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depressive and anxiety symptom severity
時間枠：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.
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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.
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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.
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Positive Mental Health and Quality of Life
時間枠：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.
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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.
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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.
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Therapist Decision Making
時間枠：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).
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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.
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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).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Client satisfaction
時間枠：Assessed at post-treatment (week 28).
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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.
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Assessed at post-treatment (week 28).
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Patient and Therapist Attitude Towards EMA-Assessment
時間枠：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)
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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.
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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)
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Therapist Treatment Evaluation
時間枠：Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).
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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)
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Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22).
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Self-Efficacy
時間枠：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.
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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.
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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.
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Decisional Self-Efficacy
時間枠：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.
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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.
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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.
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Therapeutic Alliance
時間枠：Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).
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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.
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Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28).
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Therapist Decision Making Style
時間枠：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).
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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.
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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).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Ulrich Stangier, PhD、Goethe Universität Frankfurt
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- 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.
- 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.
- Bunn H, O'Connor A. Validation of client decision-making instruments in the context of psychiatry. Can J Nurs Res. 1996 Fall;28(3):13-27.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月27日
一次修了 (推定)
2029年1月1日
研究の完了 (推定)
2029年1月1日
試験登録日
最初に提出
2026年6月22日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月9日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026-00-PBACE
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Individual participant data that underlie the results reported in the main publication of outcomes, after deidentification (text, tables, figures, and appendices) will be shared.
Further Study Protocol, Analysis Plan, Informed Consent Form and Analytic Code will be shared to researchers who provide a methodologically sound proposal.
IPD 共有時間枠
Beginning 3 months and ending 5 years following article publication.
Data are available for 5 years at the Open Science Forum under: https://doi.org/10.17605/OSF.IO/TVKMQ
IPD 共有アクセス基準
Proposals should be directed to stangier@psych.uni-frankfurt.de.
To gain access, data requestors will need to sign a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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