Increasing Access to Evidence-Based Care in Integrated Behavioral Health

NCT06347822 | Completed

• 1 other identifier: 23-011276
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychotherapy

Outcome Measures

Primary Outcomes (6)

• 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)

• 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

Secondary Outcomes (5)

• Change in Valuing Questionnaire (Values Progress subscale)

  Baseline and 2-week follow-up

• Change in Valuing Questionnaire (Values Obstruction subscale)

  Baseline and 2-week follow-up

• Change in CompACT scores (Valued Action)

  Baseline and 2-week follow-up

• Change in CompACT scores (Openness to Experience)

  Baseline and 2-week follow-up

• Change in CompACT scores (Behavioral Awareness)

  Baseline and 2-week follow-up

Study Arms (1)

Single-Session Therapy Visit

EXPERIMENTAL

Subjects will have a single-session therapy visit with an Integrated Behavioral Health (IBH) clinician.

Behavioral: Therapy Session

Interventions

Therapy Session BEHAVIORAL

Single-session intervention (SSI) based on acceptance and commitment therapy (ACT) and solution-focused brief therapy (SFBT) principles

Single-Session Therapy Visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Anne Roche, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 4, 2024
• Study Start: June 17, 2024
• Primary Completion: May 19, 2025
• Study Completion: June 5, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)