AnxietyPBTNCT07352592
Process-Based Approach Case Series For Anxiety Problems
A study testing Process-Based Approach in people with Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A case series of PBA intervention for anxiety problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Process-Based Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Score on GAD-7 >10 at baseline
- Access to mobile device
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham Dr. Borgogna's lab
Birmingham, Alabama, 35233
Nicholas Borgogna, PhD, (205) 934-3850, borgogna@uab.edu
Drew Whittington MS (Research Coordinator), MS, (205) 934-3850, whitdrew@uab.edu
About this study
Official title: PBT For Anxiety Problems
A case series of PBA intervention for anxiety problems.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Process-Based Approach
- Keywords
- PBT, PBA, Process-Based Approach, Process-Based Cognitive Behavioral Therapy, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process-Based ApproachBehavioural
Also called PBT
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).
| Study group | Role | What they receive |
|---|---|---|
| Process-based approach | Experimental | PBA therapy Receives: Behavioral: Process-Based Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7
Anxiety scale
Measured: From enrollment to the end of treatment, up to 25 weeks.
Beck Anxiety Inventory
Anxiety Measure
Measured: From enrollment to the end of treatment, up to 25 weeks.
Secondary outcomes (5)
Patient Health Questionnaire-9
Depression measure
Measured: From enrollment to the end of treatment, up to 25 weeks.
Experiential Avoidance Rating Scale
Experiential avoidance measure
Measured: From enrollment to the end of treatment, up to 25 weeks.
Quality of Life Scale
Quality of Life Measure
Measured: From enrollment to the end of treatment, up to 25 weeks.
Big Five Inventory
Measure of Personality
Measured: From enrollment to the end of treatment, up to 25 weeks.
PSY-Flex
Psychological flexibility measure
Measured: From enrollment to the end of treatment, up to 25 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas C. Borgogna, University of Alabama at Birmingham
- Investigators
- Nicholas C Borgogna, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352592
- Sponsor's protocol ID
- IRB-300015520
- Other IDs
- No funding
- Acronym
- PBT
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified outcome scores will be shared in publication. Raw scores are available upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PBT For Anxiety Problems
- ClinicalTrials.gov ID
- NCT07352592
- Acronym / sponsor ID
- PBT / IRB-300015520
- Conditions
- Anxiety
- Keywords
- PBT, PBA, Process-Based Approach, Process-Based Cognitive Behavioral Therapy, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A case series of PBA intervention for anxiety problems.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Process-based approach | Experimental | Behavioral: Process-Based ApproachPBA therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Score on GAD-7 >10 at baseline
- Access to mobile device
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Process-Based ApproachAlso: PBTProcess-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). | Behavioural | Process-based approach |
Primary outcome
Generalized Anxiety Disorder-7
Time frame: From enrollment to the end of treatment, up to 25 weeks.
Anxiety scale
Beck Anxiety Inventory
Time frame: From enrollment to the end of treatment, up to 25 weeks.
Anxiety Measure
5 secondary outcomes
Patient Health Questionnaire-9
Time frame: From enrollment to the end of treatment, up to 25 weeks.
Experiential Avoidance Rating Scale
Time frame: From enrollment to the end of treatment, up to 25 weeks.
Quality of Life Scale
Time frame: From enrollment to the end of treatment, up to 25 weeks.
Big Five Inventory
Time frame: From enrollment to the end of treatment, up to 25 weeks.
PSY-Flex
Time frame: From enrollment to the end of treatment, up to 25 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified outcome scores will be shared in publication. Raw scores are available upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas C Borgogna, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Process-Based Approach in people with Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damion D Whittinton, MS ((205) 934-3850, whitdrew@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (time frame: From enrollment to the end of treatment, up to 25 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.