AnxietyNCT05105568
Process-Based Therapy in an Outpatient Setting
A study testing Process-based therapy in people with Anxiety and Depression, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Process-based therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders (CARD)
Boston, Massachusetts, 02215
About this study
Official title: Process-Based Therapy in an Outpatient Setting: A Multiple Baseline Study
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Process-based therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process-based therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Process-based therapy | Experimental | Not described Receives: Behavioral: Process-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 months
Secondary outcomes (1)
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.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start16 Nov 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: PI moved to different institution and continuing was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Model description
- Nonconcurrent multiple baseline design with three dyads.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105568
- Sponsor's protocol ID
- 6214
- Status last verified
- Jul 2023
- First submitted
- 5 Oct 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process-Based Therapy in an Outpatient Setting: A Multiple Baseline Study
- ClinicalTrials.gov ID
- NCT05105568
- Acronym / sponsor ID
- 6214
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to different institution and continuing was not feasible.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 3 Nov 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nonconcurrent multiple baseline design with three dyads.
| Arm | Type | Receives |
|---|---|---|
| Process-based therapy | Experimental | Behavioral: Process-based therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 therapyProcess-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. | Behavioural | Process-based therapy |
Primary outcome
Individual network structure
Time frame: Up to 7 months
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.
1 secondary outcome
Process-Based Assessment Tool
Time frame: Up to 7 months
Results and safety
The study was stopped early (reason given: PI moved to different institution and continuing was not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- BackgroundCiarrochi, 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.
- BackgroundHofmann, 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy in people with Anxiety and Depression, run by Boston University Charles River Campus 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Aug 2023. 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?
The study was stopped early (reason given: PI moved to different institution and continuing was not feasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual network structure (time frame: Up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105568, which also lists 2 linked publications.
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 1 Aug 2023.