Process-Based Approach Case Series For Anxiety Problems (PBT)

A case series of PBA intervention for anxiety problems.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Process-Based Approach

Detailed Description

Participants will self-refer to this study by emailing a research assistant (Mr. Whittington).

They will then attend a screening session where they complete an informed consent form and are assessed for inclusion/exclusion criteria. During the screening the research assistant will conduct a clinical interview and collaboratively identify hypothetical processes (e.g. avoidance) that might be contributing to the participants anxiety symptoms. Together, they will identify 8-items from the process-based assessment tool (see survey) that might be relevant to the participants anxiety.

Participants will then complete a baseline survey battery on a lab computer (via Qualtrics; ~20 minutes).

Participants will then complete a two-week assessment period where they complete brief (<2 minute) surveys five times a day (approximately 9 am, noon, 2 pm, 5 pm, and 8 pm) each day for the two weeks. These surveys will be sent to participants' phone via Qualtrics. These surveys will be the 8-items identified during the intake session, with one additional item assessing momentary anxiety and an additional item assessed momentary quality of life perception.

The research team will use the data gathered during the two-week assessment period to create personalized networks of processes leading to participant anxiety symptoms. Each participants' network will guide their therapy treatment.

Participants will then attend up to 25 sessions of counseling for their anxiety. Sessions will occur roughly weekly and will last approximately 50 minutes. All sessions will occur in Dr. Borgogna's lab and clinic space (Campbell Hall Ste 310) on the UAB campus. The therapists in the study will all be masters-level clinicians in the UAB medical/clinical psychology program preparing for licensure (Mr. Whittington, Mr. Johnson, and Ms. Jafari) or a licensed clinical psychologist (Dr. Borgogna). Therapy sessions for pre-licensed clinicians will be recorded onto a UAB computer in Dr. Borgogna's lab and reviewed for supervision purposes by Dr. Borgogna (A/V recordings not for research purposes). Recordings will be deleted within 30 days of each therapy session.

Participants will complete the main battery again at post-test.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damion D Whittinton, MS; Phone Number: (205) 934-3850; Email: whitdrew@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Process-based approach; PBA therapy

Behavioral: Process-Based Approach; 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).; Other Names: PBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	Depression measure	From enrollment to the end of treatment, up to 25 weeks.
Experiential Avoidance Rating Scale	Experiential avoidance measure	From enrollment to the end of treatment, up to 25 weeks.
Quality of Life Scale	Quality of Life Measure	From enrollment to the end of treatment, up to 25 weeks.
Big Five Inventory	Measure of Personality	From enrollment to the end of treatment, up to 25 weeks.
PSY-Flex	Psychological flexibility measure	From enrollment to the end of treatment, up to 25 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process-based assessment tool	A collection of hypothetical processes that might be correlated with mental illness outcomes. Selections will be used to inform patient conceptualizations prior to therapy.	Five times a day for two weeks prior to intervention

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Nicholas C Borgogna, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; PBA; PBT; Process-Based Approach; Process-Based Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: UAB PBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified outcome scores will be shared in publication. Raw scores are available upon request to the principal investigator.
• IPD Sharing Time Frame: 2027-2030
• IPD Sharing Access Criteria: PhD-level researchers associated with academic institutions will have access to de-identified spreadsheets and code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No