NCT07352592

Brief Summary

A case series of PBA intervention for anxiety problems.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
19mo left

Started May 2026

Typical duration for not_applicable anxiety

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Dec 2027

First Submitted

Initial submission to the registry

January 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

January 9, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

PBTPBAProcess-Based ApproachProcess-Based Cognitive Behavioral TherapyAnxiety

Outcome Measures

Primary Outcomes (2)

  • Generalized Anxiety Disorder-7

    Anxiety scale

    From enrollment to the end of treatment, up to 25 weeks.

  • Beck Anxiety Inventory

    Anxiety Measure

    From enrollment to the end of treatment, up to 25 weeks.

Secondary Outcomes (5)

  • Patient Health Questionnaire-9

    From enrollment to the end of treatment, up to 25 weeks.

  • Experiential Avoidance Rating Scale

    From enrollment to the end of treatment, up to 25 weeks.

  • Quality of Life Scale

    From enrollment to the end of treatment, up to 25 weeks.

  • Big Five Inventory

    From enrollment to the end of treatment, up to 25 weeks.

  • PSY-Flex

    From enrollment to the end of treatment, up to 25 weeks.

Other Outcomes (1)

  • Process-based assessment tool

    Five times a day for two weeks prior to intervention

Study Arms (1)

Process-based approach

EXPERIMENTAL

PBA therapy

Behavioral: Process-Based Approach

Interventions

Process-Based Approaches (PBA) were developed to improve psychotherapy outcomes. Early writings referred to PBA as process-based therapy or process-based cognitive behavioral therapy. The current nomenclature was adopted to distinguish PBA as a unifying approach that incrementally builds on clinical psychological science rather than a manualized treatment protocol. PBA provides a framework for flexibly applying evidence-based techniques from multiple therapeutic traditions to target hypothesized psychological processes that give rise to individual patient presentations. Each patient is conceptualized independently, and intervention structure may vary substantially based on need, while retaining empirically supported tools. This contrasts with disorder-specific treatment manuals, which assume homogeneity despite substantial variability in underlying processes (e.g., anxiety).

Also known as: PBT
Process-based approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Score on GAD-7 \>10 at baseline
  • Access to mobile device

You may not qualify if:

  • Current psychotherapy treatment
  • Current/past severe psychopathology (e.g., history of psychosis, suicide attempt or self-injury within the past 12 months, narcotics use within the past 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Nicholas C Borgogna, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Damion D Whittinton, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified outcome scores will be shared in publication. Raw scores are available upon request to the principal investigator.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
2027-2030
Access Criteria
PhD-level researchers associated with academic institutions will have access to de-identified spreadsheets and code.