Increasing Access to Evidence-Based Care in Integrated Behavioral Health

July 10, 2025 updated by: Anne I. Roche, Mayo Clinic

Implementation of Single Session Interventions in Integrated Behavioral Health: Increasing Access to Evidence-based Care

The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being a patient currently scheduled for an IBH consultation session at Mayo Clinic Rochester.
  • Able to read and speak English.

Exclusion Criteria:

  • Individuals diagnosed with psychotic spectrum, Bipolar I and II, or severe substance use disorder and individuals with severe cognitive impairment per chart review will not be eligible and will not be contacted about the study. Individuals must score ≥ 5 on the PHQ-9 and/or GAD-7 but not >14 on either measure (indicating mild to moderate depression and/or anxiety) and respond < 2 to Item 9 of the PHQ-9 ("thoughts that you would be better off dead, or thoughts of hurting yourself in some way") to be eligible for the study.
  • Patients who are ineligible will remain scheduled for a regular IBH therapy consultation as originally planned.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-Session Therapy Visit
Subjects will have a single-session therapy visit with an Integrated Behavioral Health (IBH) clinician.
Behavioral: Therapy Session
Single-session intervention (SSI) based on acceptance and commitment therapy (ACT) and solution-focused brief therapy (SFBT) principles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in PHQ-9 scores
Time Frame: Baseline and 2-week follow-up
The PHQ-9 asks participants to rate 9 questions assessing dimensions of depression on a scale of 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 27 with higher scores indicating higher levels of depression.
Baseline and 2-week follow-up
Change in GAD-7 scores
Time Frame: Baseline and 2-week follow-up
The GAD-7 asks participants to rate 7 statements based on how generally anxious they have felt over the past 2 weeks on a 4 point scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 21 with higher scores representing higher generalized anxiety.
Baseline and 2-week follow-up
Satisfaction with IBH therapy
Time Frame: Immediately post-intervention (1-1.25 hours after study visit initiation)
Measured using the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores range from 8 to 32, with higher number indicating greater satisfaction.
Immediately post-intervention (1-1.25 hours after study visit initiation)
Satisfaction with Action Plan
Time Frame: Immediately post-intervention (1-1.25 hours after study visit initiation)
We will use 3 items rated on a five-point scale (0 = not at all, 4 = very much) to assess participant satisfaction with their Action Plan ("Did the visit help you develop an action plan?"; "How hopeful are you that the action plan will be useful?" and "How motivated do you feel to use your action plan?"). Scores will range from 0-12 with higher scores indicating greater satisfaction with the Action Plan.
Immediately post-intervention (1-1.25 hours after study visit initiation)
Change in readiness for change scores
Time Frame: Baseline and immediately post-intervention (1-1.25 hours after study visit initiation)
The readiness for change ruler is a 3 item measure that examines participant's willingness to change to improve their mental health on a 0 (not at all confident/important/ready) to 10 scale (completely confident/important/ready). The total score ranges from 0 to 30, with higher scores indicating higher levels of willingness to change.
Baseline and immediately post-intervention (1-1.25 hours after study visit initiation)
Change in belief in capacity to generate routes to reach goals (pathways)
Time Frame: Baseline and immediately post-intervention (1-1.25 hours after study visit initiation)
The State Hope Scale (Pathways subscale) is a 3 item measure that assesses participant belief in their capacity to generate routes to reach goals. Scale responses range from 1 (Definitely false) to 8 (Definitely true), with total scores ranging from 3-24 and higher scores indicating higher levels of pathways thinking.
Baseline and immediately post-intervention (1-1.25 hours after study visit initiation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Valuing Questionnaire (Values Progress subscale)
Time Frame: Baseline and 2-week follow-up
The 10-item Valuing Questionnaire asks participants to rate statements about valued living on a 7-point Likert-type scale ranging from 0 (not at all true) to 6 (completely true). The measure assesses two subscales, Values Progress (0-30) and Values Obstruction (0-30), with higher scores on each indicating greater values progress and obstruction, respectively.
Baseline and 2-week follow-up
Change in Valuing Questionnaire (Values Obstruction subscale)
Time Frame: Baseline and 2-week follow-up
The 10-item Valuing Questionnaire asks participants to rate statements about valued living on a 7-point Likert-type scale ranging from 0 (not at all true) to 6 (completely true). The measure assesses two subscales, Values Progress (0-30) and Values Obstruction (0-30), with higher scores on each indicating greater values progress and obstruction, respectively.
Baseline and 2-week follow-up
Change in CompACT scores (Valued Action)
Time Frame: Baseline and 2-week follow-up
The Comprehensive Assessment of Acceptance and Commitment Therapy Processes-15 item (CompACT) is used to assess psychological flexibility (three subscales of openness to experience, behavioral awareness, and valued action). Each item is rated on a scale of 0 to 6 (0 = strongly disagree, 6 = strongly agree). Higher scores on each subscale (VA, OE, BA) indicate greater valued action (VA), greater openness to experience (OE), and greater behavioral awareness (BA), respectively.
Baseline and 2-week follow-up
Change in CompACT scores (Openness to Experience)
Time Frame: Baseline and 2-week follow-up
The Comprehensive Assessment of Acceptance and Commitment Therapy Processes-15 item (CompACT) is used to assess psychological flexibility (three subscales of openness to experience, behavioral awareness, and valued action). Each item is rated on a scale of 0 to 6 (0 = strongly disagree, 6 = strongly agree). Higher scores on each subscale (VA, OE, BA) indicate greater valued action (VA), greater openness to experience (OE), and greater behavioral awareness (BA), respectively.
Baseline and 2-week follow-up
Change in CompACT scores (Behavioral Awareness)
Time Frame: Baseline and 2-week follow-up
The Comprehensive Assessment of Acceptance and Commitment Therapy Processes-15 item (CompACT) is used to assess psychological flexibility (three subscales of openness to experience, behavioral awareness, and valued action). Each item is rated on a scale of 0 to 6 (0 = strongly disagree, 6 = strongly agree). Higher scores on each subscale (VA, OE, BA) indicate greater valued action (VA), greater openness to experience (OE), and greater behavioral awareness (BA), respectively.
Baseline and 2-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Roche, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-011276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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