Process-Based Approach Case Series For Anxiety Problems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Process-Based Approach.
- Who it may be relevant to
- Registry conditions: Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PBT For Anxiety Problems
Overview
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.
Interventions
- 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
Primary outcome measures
- Generalized Anxiety Disorder-7 [Time frame: From enrollment to the end of treatment, up to 25 weeks.]
- Beck Anxiety Inventory [Time frame: From enrollment to the end of treatment, up to 25 weeks.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham Dr. Borgogna's lab — Birmingham
Identifiers
NCT: NCT07352592 · IRB-300015520 · No funding