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NCT Number: NCT07352592

Process-Based Approach Case Series For Anxiety Problems

A case series of PBA intervention for anxiety problems.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Dr. Borgogna's lab

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Drew Whittington MS (Research Coordinator), MS

CONTACT

[email protected]

(205) 934-3850

Nicholas Borgogna, PhD

CONTACT

[email protected]

(205) 934-3850

Nicholas C Borgogna, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Process-Based Approach

Behavioral

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

Primary outcomes

  1. Generalized Anxiety Disorder-7

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

    Anxiety scale

  2. Beck Anxiety Inventory

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

    Anxiety Measure

Secondary outcomes

  1. Patient Health Questionnaire-9

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

    Depression measure

  2. Experiential Avoidance Rating Scale

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

    Experiential avoidance measure

  3. Quality of Life Scale

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

    Quality of Life Measure

  4. Big Five Inventory

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

    Measure of Personality

  5. PSY-Flex

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

    Psychological flexibility measure

Other outcomes

  1. Process-based assessment tool

    Time frame: Five times a day for two weeks prior to intervention

    A collection of hypothetical processes that might be correlated with mental illness outcomes. Selections will be used to inform patient conceptualizations prior to therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Damion D Whittinton, MS

CONTACT

[email protected]

(205) 934-3850

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

PBT For Anxiety Problems

Acronym: PBT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 20, 2026
Registry last updated
Jun 12, 2026

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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