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NCT Number: NCT06517589

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

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.

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Key information

Conditions

Depression Anxiety Disorder Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators 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 anxiety disorders and depression.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Cognitive behavioral therapy (CBT)

Other

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

Primary outcomes

  1. Depression Anxiety Stress Scale (DASS-21)

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

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

Secondary outcomes

  1. Euroqol-5D (EQ-5D)

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

    Health related quality of life, minimum health state=11111, maximum health state=55555, higher scores in health state mean worse outcome, minimum health score=0, maximum health score=100, higher scores in health score mean better outcome

  2. Positive-Mental Health Scale (PMH)

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

    Positive mental health, minimum value=9, maximum value=36, higher scores mean better outcome

  3. Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

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

    Pleasure in interpersonal situations, minimum value=17, maximum value=102, higher scores mean better outcome

  4. Depression Anxiety Stress Scale (DASS-10)

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

    Psychological symptoms of distress, depressive and anxious symptoms, minimum value=0, maximum value=30, higher scores mean worse outcome

  5. Acceptance and Action Questionnaire Version 2 (AAQ-2)

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

    Psychological flexibility and acceptance, minimum value=7, maximum value=49, higher scores mean worse outcome

  6. Reflective Functioning Questionnaire (RFQ-8)

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

    Reflective Functioning, minimum value=8, maximum value=56, higher scores on the uncertainty dimension mean worse outcome, higher scores in the certainty dimension mean better outcomes

  7. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Assessed at post-treatment at week 32

    Client Satisfaction, minimum value=8, maximum value=32, higher scores mean better outcome

  8. Process-based Assessment Tool (PBAT)

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

    Variation, selection and retention of adaptive behavior, minimum value=0, maximum value=1800, higher scores mean better outcome

  9. Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)

    Time frame: Assessed at inclusion, pre-treatment, weekly during the treatment (from week 11 to 30), at post-treatment (week 32) and at 6 month follow-up

    Patients use of CBT interventions, minimum value=6, maximum value=42, higher scores mean better outcome

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

Collaborators

  • Philipps University Marburg

Registry information

Official study title

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

Acronym: PBTRAND

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Jul 30, 2024

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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