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OpenTrials
Completed

NCT Number: NCT06347822

Increasing Access to Evidence-Based Care in Integrated Behavioral Health

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.

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Key information

Conditions

Psychotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapy Session

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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