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Process-Based Therapy in an Outpatient Setting

Primary Purpose

Anxiety, Depression

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Process-based therapy

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability and willingness to provide written informed consent
Ability to sufficiently communicate in English as assessed through phone screening and the ability to answer study questionnaires
At least 18 years old
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)
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)
Working smartphone with internet connection
Stable on current psychotropic medications (or off medication for 2 weeks)
If participating remotely, access to private room where they will not be disturbed during study sessions

Exclusion Criteria:

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
Currently receiving another psychological treatment
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
Serious neurological impairment as assessed through phone screening items or otherwise determined by the Investigator
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

Sites / Locations

Center for Anxiety and Related Disorders (CARD)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Process-based therapy

Arm Description

Outcomes

Primary Outcome Measures

Individual network structure

Network models will be created using intensive longitudinal data collected four times daily. Variables to be measured will depend on the participant's presenting concern. For example, if Participant A reports struggling with avoiding work meetings related to fears about how they will be perceived by their supervisor and co-workers, then we might track percentage of work meetings attended (behavioral goal) and fear of social evaluation (source of distress). Where possible, these items will be assessed using a visual analog scale ranging from 0 to 100 to ensure an adequate range of responding. Because items will be personalized to the participant's presenting concern, we will not be using a standardized scale or questionnaire. Rather, we will be developing idiographic items specific to the participant's presentation and assess variables relevant to the individual.

Secondary Outcome Measures

Process-Based Assessment Tool

The Process-Based Assessment Tool (PBAT) is a new measure that is currently being validated (Ciarrochi et al., 2021, in preparation). The PBAT has 9 subscales: affect, cognitive processes, attention, social/connection needs, motivation/autonomy needs, overt behavior/competence needs, health, variation, and retention.

Full Information

NCT ID

NCT05105568

First Posted

October 5, 2021

Last Updated

July 28, 2023

Sponsor

Boston University Charles River Campus

1. Study Identification

Unique Protocol Identification Number

NCT05105568

Brief Title

Process-Based Therapy in an Outpatient Setting

Official Title

Process-Based Therapy in an Outpatient Setting: A Multiple Baseline Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

PI moved to different institution and continuing was not feasible.

Study Start Date

November 16, 2021 (Actual)

Primary Completion Date

July 31, 2022 (Actual)

Study Completion Date

July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University Charles River Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Nonconcurrent multiple baseline design with three dyads.

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Process-based therapy

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Process-based therapy

Intervention 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. Depending on the participant's presentation, PBT would be shaped by different evidence-based techniques. Examples of evidence-based procedures include: behavioral activation, exposures, mindfulness, self-compassion, values exploration, and contingency management.

Primary Outcome Measure Information:

Title

Individual network structure

Description

Time Frame

Up to 7 months

Secondary Outcome Measure Information:

Title

Process-Based Assessment Tool

Description

Time Frame

Up to 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability and willingness to provide written informed consent Ability to sufficiently communicate in English as assessed through phone screening and the ability to answer study questionnaires At least 18 years old 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) 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) Working smartphone with internet connection Stable on current psychotropic medications (or off medication for 2 weeks) If participating remotely, access to private room where they will not be disturbed during study sessions Exclusion Criteria: 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 Currently receiving another psychological treatment 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 Serious neurological impairment as assessed through phone screening items or otherwise determined by the Investigator 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

Facility Information:

Facility Name

Center for Anxiety and Related Disorders (CARD)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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.

Results Reference

background

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.

Results Reference

background

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Process-Based Therapy in an Outpatient Setting

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