Clinical trial NCT05105568: Process-Based Therapy in an Outpatient Setting
Official title: Process-Based Therapy in an Outpatient Setting: A Multiple Baseline Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nonconcurrent multiple baseline design with three dyads.
Primary purpose: TREATMENT

Brief summary: The proposed study aims to examine the effects of process-based therapy on 6 adult patients presenting for treatment at a university community outpatient clinic using a nonconcurrent multiple baseline design.

Detailed description: Process-based therapy (PBT) is a meta-theoretical model of evidence-based therapies that organizes adaptive and maladaptive processes of change using complex and dynamic networks based on an evolution science framework. Although papers and books have been written on PBT, PBT has yet to be empirically tested as an intervention in a clinical setting. The proposed study aims to examine the effects of PBT on 6 adult patients presenting for treatment at a university community outpatient clinic using a nonconcurrent multiple baseline design. We hypothesize that network structures of patients will change in an adaptive direction over the course of PBT and that these changes will be maintained at 1-month follow-up.

The study will take place remotely over HIPAA-compliant Zoom or in person at the Center for Anxiety and Related Disorders (CARD), depending on the status of the COVID-19 pandemic and participants' preferences. Variables of interest include idiographic items specific to the individual (e.g., treatment goals, problem behaviors, valued action, psychological phenomena, contextual influences) and physiological data (e.g., physical activity, screen time). Throughout the study until 1-month follow-up, participants will be randomly prompted 4 times a day to rate idiographic items via Ethica, an app-based platform for smartphones that collects questionnaire data and passive objective data from sensors. Physiological data will be collected passively through Ethica. These variables will comprise the network used to characterize each participant's presentation. In addition to examining network structures, we will use the Process-Based Assessment Tool (PBAT; Ciarrochi, Hayes, Hofmann, 2021) as a nomothetic measure of PBT-related improvement. The proposed study will provide a proof of concept for PBT, evaluate its efficacy, and demonstrate how it can be applied in a real-world setting.

Eligibility criteria: Inclusion Criteria:

1. Ability and willingness to provide written informed consent
2. Ability to sufficiently communicate in English as assessed through phone screening and the ability to answer study questionnaires
3. At least 18 years old
4. Seeking psychological treatment at CARD (participants do not need to meet criteria for a specific Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis)
5. Willingness to abstain from other psychotherapies for duration of study (up to 1-month follow-up; this is so we can be more confident that changes observed during the study are attributable to the study intervention rather than an external intervention; clinically, it is also typically counterproductive for a patient to see multiple therapists at the same time)
6. Working smartphone with internet connection
7. Stable on current psychotropic medications (or off medication for 2 weeks)
8. If participating remotely, access to private room where they will not be disturbed during study sessions

Exclusion Criteria:

1. Suicidality (ideation, intent, or specific plan) significant enough to require higher level of care than outpatient, as determined by CARD phone screening (patients on the CARD waitlist who comprise our recruitment pool are prescreened), the Mini International Neuropsychiatric Interview (MINI), or otherwise determined by the Investigator
2. Currently receiving another psychological treatment
3. Active psychosis, mania, or significant personality dysfunction as assessed through CARD phone screening (patients on the CARD waitlist who comprise our recruitment pool are prescreened), the MINI, or otherwise determined by the Investigator
4. Serious neurological impairment as assessed through phone screening items or otherwise determined by the Investigator
5. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, interfere with study compliance, or confound study results

Primary outcomes:
measure: Individual network structure
timeFrame: Up to 7 months
Secondary outcomes:
measure: Process-Based Assessment Tool
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Related Disorders (CARD)
state: Massachusetts
Study officials:
References:
citation: Ciarrochi, J., Hayes, S. C., & Hofmann, S. G. (2021). Assessing processes of change in psychological interventions: The Process-Based Assessment Tool (PBAT). Manuscript in preparation. Institute for Positive Psychology and Education, Australian Catholic University.
citation: Hofmann, S. G., Hayes, S. C., & Lorscheid, D. N. (2021). Learning process-based therapy: A skills training manual for targeting the core processes of psychological change in clinical practice. New Harbinger.