Skip to main content
Clinical Trials/NCT06347822
NCT06347822
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country34 target enrollmentJune 17, 2024
ConditionsPsychotherapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychotherapy
Sponsor
Mayo Clinic
Enrollment
34
Locations
1
Primary Endpoint
Change in readiness for change scores
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2024
End Date
June 5, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne I. Roche

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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

  • Change in CompACT scores (Valued Action)(Baseline and 2-week follow-up)
  • 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 (Openness to Experience)(Baseline and 2-week follow-up)
  • Change in CompACT scores (Behavioral Awareness)(Baseline and 2-week follow-up)

Study Sites (1)

Loading locations...

Similar Trials