Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06347822
Other study ID # 23-011276
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date October 2024

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Recruiting NCT05030285 - Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment N/A
Not yet recruiting NCT05863637 - Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting N/A
Active, not recruiting NCT05018312 - Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety N/A
Not yet recruiting NCT06038747 - Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol. N/A
Not yet recruiting NCT00808600 - Empowerment of Lung and Heart-lung Transplant Patients N/A
Not yet recruiting NCT03706001 - Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression N/A
Recruiting NCT05587517 - A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients Phase 2
Completed NCT05385458 - Acceptance and Commitment Therapy (ACT) Tele-Counselling N/A
Not yet recruiting NCT06366685 - Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy N/A
Active, not recruiting NCT04950608 - Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care Phase 2
Not yet recruiting NCT05613972 - Brief Suicide & Trauma Therapy for Suicide Risk N/A
Active, not recruiting NCT03692130 - Treatment of Depression With Mindfulness, Acceptance and Commitment N/A
Recruiting NCT03806569 - MAC-cbt Group Therapy for Adults With ADHD N/A
Recruiting NCT05356611 - Engage for Late-Life Depression and Comorbid Executive Dysfunction N/A
Not yet recruiting NCT05317598 - The Key Model Of Courtesy And Integrıty N/A
Not yet recruiting NCT06353282 - MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents Phase 2
Not yet recruiting NCT03813264 - Optimizing Outcomes of Dynamic Psychotherapy by the MATRIX: A Preliminary Study N/A
Completed NCT05289583 - Impact of Therapeutic Alliance on Dropout in a Naturalistic Sample of Patients With Borderline Pathology Receiving Residential DBT
Completed NCT03937167 - Benefits of Group Psychotherapy Programs in the Treatment of Obesity N/A