Increasing Access to Evidence-Based Care in Integrated Behavioral Health

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: Completed
• Conditions: Psychotherapy
• Intervention / Treatment: Behavioral: Therapy Session

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in PHQ-9 scores	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	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	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	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	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)	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

Outcome Measure	Measure Description	Time Frame
Change in Valuing Questionnaire (Values Progress subscale)	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)	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)	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)	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)	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

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Anne Roche, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): May 19, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID 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