Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression

NCT06517589 | Recruiting

• 1 other identifier: III L5-519/05.000.002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.

Conditions

Depression; Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety Stress Scale (DASS-21)

  Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome

  Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

Secondary Outcomes (9)

• Euroqol-5D (EQ-5D)

  Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

• Positive-Mental Health Scale (PMH)

  Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

• Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

  Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

• Depression Anxiety Stress Scale (DASS-10)

  Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

• Acceptance and Action Questionnaire Version 2 (AAQ-2)

  Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up

Study Arms (2)

Process-based Cognitive Behavioral Therapy

EXPERIMENTAL

In PBT (20 sessions), treatment is initiated by a collaborative interpretation of the dynamic network model using smartphone-based Ecological Momentary Assessment collected during the baseline. Based on the outcome of the dynamic network model, interventions are selected on the basis of empirical evidence for mechanisms of change matching to the central node of the individual patient, besides feedback loops and self-loops, as the key process maintaining the maladaptive pattern. Interventions are conceptualized in the evolutionary framework as variation, selection and retention of an adaptive mode of the central node related to the specific context of the problem. The change of this variable is monitored using daily judgements on the basis of EMA. Further treatment planning focuses on additional targets to establish the adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled in statistical analyses.

Other: Process-based Cognitive Behavioral Therapy (PBT)

Traditional Cognitive Behavioral Therapy

ACTIVE COMPARATOR

In r-CBT (20 sessions) a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the effects of the interventions on factors maintaining the disorder, e.g. avoidance and exposure in anxiety disorder or reduced reinforcement of activities and behavioral activation in depression. Interventions are selected on the basis of common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to taylor the techniques to the problem behaviors or dysfunctional thoughts of patients. Treatment process focuses mainly on the implementation of the manualized interventions adapted to the individual patient as recommended in the National guidelines for treatment of depression and anxiety disorders. Concomitant medication is allowed and will be controlled in statistical analyses.

Other: Cognitive Behavioral Therapy (CBT)

Interventions

Process-based Cognitive Behavioral Therapy (PBT) OTHER

PBT (20 sessions), intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.

Process-based Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT) OTHER

CBT (20 sessions), intervention planning as usual based on manual.

Traditional Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A primary DSM-5 diagnosis of depressive or anxiety disorder
• At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
• 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

You may not qualify if:

• Increased suicidality
• Substance abuse or dependency
• Borderline personality disorder
• Pervasive developmental disorder
• Psychotic disorder
• Eating disorder
• Bipolar disorder
• Severe physical illness

Sponsors & Collaborators

• Goethe University: lead
• Philipps University Marburg: collaborator

Study Sites (1)

JWGUniversity

Frankfurt am Main, Hesse, 60486, Germany

RECRUITING

Related Publications (1)

• Stangier U, Kohl V, Gorg N, Sendig L, Hufschmidt B, Bonarius D, Nemani A, Ebert M, Hofmann SG. Process-based therapy vs. routine-CBT for difficult-to-treat mood and anxiety disorders: study protocol for a randomized controlled trial. Trials. 2024 Dec 19;25(1):838. doi: 10.1186/s13063-024-08689-3.

  PMID: 39702504 DERIVED

Related Links

• Website

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Ulrich Stangier, PhD

CONTACT

049 1707339293; stangier@psych.uni-frankfurt.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Clinical Psychology and Psychotherapy and Center for Psychotherapy

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: January 29, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 30, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication. Data are available for 5 years at a third party website (Link to be included).
• Access Criteria: Proposals should be directed to stangier@psych.uni-frankfurt.de. To gain access, data requestors will need to sign a data access agreement.

Locations

DE (1)