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Clinical Trials/NCT05866185
NCT05866185
Completed
Not Applicable

Improving Adherence to Evidence-Based Practice Using an Innovative and Easy-to-Use Health IT Solution

University of South Florida1 site in 1 country79 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of South Florida
Enrollment
79
Locations
1
Primary Endpoint
Generalized Anxiety Disorder-7 (Gad-7)
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

The purpose of this study is to expand Adhere.ly- a simple, HIPAA-compliant, web-based platform to help therapists engage clients in practicing therapeutic skills between sessions (homework) during mental health treatment by conducting a trial comparing standard therapy to therapy enhanced with Adhere.ly.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
May 29, 2024
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English-speaking
  • Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
  • Carry active mental health treatment caseloads in the U.S.
  • Have a laptop, tablet, or smartphone with internet access
  • English-speaking
  • Treatment-seeking adults ≥18 years
  • Clinically elevated anxiety and depression as indicated by a score ≥10 on the GAD-7 and/or PHQ-8
  • Have a laptop, tablet, or smartphone with internet access

Exclusion Criteria

  • Client with self-reported:
  • Active psychotic symptoms (e.g., hallucinations, delusions)
  • Significant cognitive disability.

Outcomes

Primary Outcomes

Generalized Anxiety Disorder-7 (Gad-7)

Time Frame: Baseline, 3 Months Post Baseline

The Generalized Anxiety Disorder Scale-7 (GAD-7) assesses the severity of anxiety symptoms in adults. The GAD-7 was completed by clients about themselves. Scores range from 0 to 21 with higher scores indicating worse anxiety symptom severity. A score of 8 or greater is generally considered to indicate clinically significant anxiety symptom severity.

Patient Health Questionnaire-8 (PHQ-8)

Time Frame: Baseline, 3 Months Post Baseline

The Patient Health Questionnaire-8 (PHQ-8) assesses the severity of depression symptoms in adults. The PHQ-8 was completed by clients about themselves. Scores range from 0 to 28 with higher scores indicating worse depression symptom severity. A score of 10 or greater is generally considered to indicate clinically significant depression symptom severity.

Secondary Outcomes

  • Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index(Baseline, 3 Months Post Baseline)
  • Homework Rating Scale II (HRS II)(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.)
  • Assessment of Core CBT Skills (ACCS) - Cognitive Behavioral Therapy Domain(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.)
  • Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale(Baseline, Post-Trial Therapist Assessment)
  • Working Alliance Inventory - Short Revised (WAI-SR)(3 Months Post Baseline)
  • Client Satisfaction Questionnaire - 8 (CSQ-8)(3 Months Post Baseline)
  • Assessment of Core CBT Skills (ACCS) - Homework Domain(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.)
  • Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale(Baseline, Post-Trial Therapist Assessment)

Study Sites (1)

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