10 Participants NeededMy employer runs this trial

Process-Based Approach for Anxiety

(PBT Trial)

DD
Overseen ByDamion D Whittinton, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with anxiety, known as the Process-Based Approach. The goal is to determine if this therapy can effectively reduce anxiety symptoms. Individuals who frequently feel anxious and score above 10 on the GAD-7 anxiety questionnaire might be suitable candidates. Participants must have a mobile device and should not be currently in other therapy or have experienced severe mental health issues recently. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research in anxiety treatment.

What prior data suggests that this process-based approach is safe for treating anxiety?

Research has shown that the Process-Based Approach (PBA) therapy is generally well-tolerated by people with anxiety. One study examining various psychological treatments found that about 70% of participants responded well to Internet-based cognitive behavioral therapy (ICBT), which shares similarities with PBA. This suggests that many individuals benefit from these treatments without major issues.

Additionally, evidence from exposure-based treatments, which resemble PBA in some aspects, has demonstrated a significant decrease in anxiety symptoms over time. This supports the notion that these approaches are safe and effective for many individuals.

While specific safety data for PBA therapy itself may not be detailed, findings from similar therapies indicate it is likely to be well-tolerated with few side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Process-Based Approach (PBA) for anxiety because it offers a fresh perspective compared to traditional therapies like cognitive-behavioral therapy (CBT) and medication. Unlike standard treatments that often focus on symptom reduction, PBA emphasizes understanding and modifying the underlying psychological processes contributing to anxiety. This method encourages personalized therapy, tailoring interventions to individual needs rather than a one-size-fits-all approach. By targeting core processes, PBA could potentially offer more sustainable and meaningful improvements for those struggling with anxiety.

What evidence suggests that the Process-Based Approach is effective for anxiety?

Research has shown that a process-based approach (PBA), which participants in this trial will receive, can help treat anxiety. A review found that similar methods, such as online cognitive behavioral therapy (CBT), have a success rate of about 70% for various mental health issues. Studies indicate that process-based therapy reduces anxiety by focusing on each person's unique experiences and progress. This method is flexible and tailored to meet individual needs, which can be helpful for managing complex anxiety problems. While research continues, early results are promising.15678

Who Is on the Research Team?

NC

Nicholas C Borgogna, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people with significant anxiety, shown by a GAD-7 score over 10, who have access to a mobile device. It does not specify other exclusions.

Inclusion Criteria

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

Exclusion Criteria

I am currently receiving psychotherapy.
Current or past severe psychopathology including history of psychosis, suicide attempt or self-injury within the past 12 months, narcotics use within the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session
1 visit (in-person)

Baseline Assessment

Participants complete a baseline survey battery on a lab computer

20 minutes
1 visit (in-person)

Two-week Assessment Period

Participants complete brief surveys five times a day for two weeks

2 weeks

Treatment

Participants attend up to 25 sessions of counseling for their anxiety

Up to 25 weeks
Up to 25 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Process-Based Approach

Trial Overview

The study is testing a Process-Based Approach (PBA) intervention designed to help people manage anxiety problems. Participants will receive this treatment and their progress will be tracked as part of a case series.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Process-based approachExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Efficacy of a process-based, Mobile-delivered personalized ...

A systematic review indicated that the overall treatment response rate for ICBT across various psychological conditions is approximately 69.9 %, ...

Process-based therapy vs. routine-CBT for difficult-to-treat ...

The study is a randomized controlled trial (RCT) of PBT vs r-CBT for difficult-to-treat unipolar depression and anxiety disorders. In total, 80 ...

A randomized clinical trial of behavioral activation and ...

Compared to EXP, BA yielded more rapid declines in anxiety and depression scores during therapy (d=0.75–0.77), as well as lower anxiety and depression scores (d ...

Process-based therapy: A personalized approach to ...

PBT emphasizes tracking patient progress over time and treating symptoms based on current experiences, as well as understanding a patient's past and predicting ...

A process-based approach to cognitive behavioral therapy

PBT is a general approach to clinical assessment, conceptualization, and treatment, representing a model of models. PBT is not a new therapy.

Effectiveness of exposure-based treatment for childhood ...

From pre-treatment to follow-up, there was a large-sized reduction of anxiety symptoms, small-sized decrease of subjective anxiety and a large-sized increase in ...

Study protocol for a randomized controlled trial

Outcome measures will include Brief Symptom Inventory, specific measures of anxiety, usability metrics, and dropout rates. Assessments will be ...

The effects of safety behaviors during exposure therapy for ...

In the context of clinical anxiety, safety behaviors are actions performed to prevent, escape, or minimize feared.