Evidence map›Paper›PMID 39702504›Full record

ArticleTrials2024

Process-based therapy vs. routine-CBT for difficult-to-treat mood and anxiety disorders: study protocol for a randomized controlled trial.

Ulrich Stangier, Viktoria Kohl, Nora Görg, Lucie Sendig, Bettina Hufschmidt, Desiree Bonarius, Arwin Nemani, Mareike Ebert, Stefan G Hofmann

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06517589 (Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06517589 naunknown statusnot on this map

Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression

TypeinterventionalSponsorGoethe UniversityRan2024 to 2025Enrolled80ConditionsDepression, Anxiety DisorderArmsProcess-based Cognitive Behavioral Therapy (PBT), Cognitive Behavioral Therapy (CBT)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ulrich StangierDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany. stangier@psych.uni-frankfurt.de.ORCID http://orcid.org/0000-0002-1945-1704
Viktoria KohlDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Nora GörgDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Lucie SendigDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Bettina HufschmidtDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Desiree BonariusDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Arwin NemaniDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Mareike EbertDepartment of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, Frankfurt, 60486, Germany.
Stefan G HofmannDepartment of Psychology, Philipps University Marburg, Schulstr. 12, 35037, Marburg/Lahn, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProcess-based therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data and dynamic and idiographic network analyses. Support for its applicability has been reported from a single-case studies. Here, we examine the feasibility and effectiveness of PBT in a larger clinical sample. We have translated a training manual of PBT and modified for delivery of CBT in mental health service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat mood and anxiety disorders.

methodsThe study is a randomized controlled trial (RCT) of PBT vs r-CBT for difficult-to-treat unipolar depression and anxiety disorders. In total, 80 patients are recruited at an outpatient clinic and included in two intervention arms. Primary outcome is emotional distress; secondary outcomes include psychological well-being and quality of life, adaptive behavior, psychological flexibility, and reflective functioning. Assessments of outcome variables are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes are collected for every session to investigate process of change. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and adherence with manual will be monitored using self-report. DISCUSSION: The current study will be the first RCT of PBT in a health care setting. The planned moderator and mediator analyses will clarify the mechanisms of change in psychotherapy and the association between personalized assessment based on dynamic network analysis and treatment effect.

trial registrationClinicalTrials.gov NCT06517589. Registered 24 July 2024.

Indexed as

Anxiety DisordersCognitive Behavioral TherapyMood DisordersAdultAffectEcological Momentary AssessmentFemaleHumansMaleMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeCognitive behavioral therapyDifficult to treat depressionDynamic network analysisProcess-based therapyRandomized controlled trial

Identifiers

PMID39702504
PMCPMC11657819

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.