Improving Adherence to Homework During Therapy (Adherely STTR)

August 15, 2023 updated by: University of South Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Janelle F Barrera, MPH
  • Phone Number: 8136442674
  • Email: jfb@usf.edu

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Brian E Bunnell, PhD
        • Contact:
          • Janelle F Barrera Ikan, MPH
          • Phone Number: 813-644-2674
          • Email: jfb@usf.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Providers:

  • 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

Clients:

  • English-speaking
  • Treatment-seeking adults ≥18 year
  • 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, developmental delays, or pervasive developmental disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therapy
Standard regular therapy.
Behavioral: Therapy
The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.
Experimental: Therapy + Adhere.ly
Standard regular therapy, enhanced with Adhere.ly
Behavioral: Therapy + Adhere.ly
Participants receive therapy as usual enhanced with a simple, HIPAA-compliant, web-based application to help mental health providers implement homework during therapy for adults with elevated anxiety and/or depression. The three major components of the app help providers to (1) Practice interactive, digitized therapeutic exercises with patients in-session; (2) Remind patients to practice exercises for homework, and (3) Review homework during the next session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (Gad-7)
Time Frame: Baseline
The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population
Baseline
Generalized Anxiety Disorder-7 (Gad-7)
Time Frame: 3-Months Post-Baseline
The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population
3-Months Post-Baseline
Patient Health Questionnaire-8 (Phq-8)
Time Frame: Baseline
The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies
Baseline
Patient Health Questionnaire-8 (Phq-8)
Time Frame: 3-Months Post-Baseline
The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies
3-Months Post-Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homework Rating Scale II (HRS II)
Time Frame: Weekly between Baseline and 3-Months Post-Baseline
The Homework Rating Scale II (HRS II) is a 4-item self-report questionnaire that assesses levels of homework adherence in cognitive behavior therapy. Total scores range from 0 to 8 with higher scores reflecting greater homework adherence.
Weekly between Baseline and 3-Months Post-Baseline
Attitudes Toward Homework Questionnaire (ATHQ)
Time Frame: Baseline
A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy
Baseline
Attitudes Toward Homework Questionnaire (ATHQ)
Time Frame: 3-Months Post-Baseline
A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy
3-Months Post-Baseline
Health-Related Quality of Life (CDC HRQOL-14)
Time Frame: Baseline
The CDC HRQOL-14 is a questionnaires that provide a summary score of an individual's overall perceived health status and health-related functional disability
Baseline
Health-Related Quality of Life (CDC HRQOL-14)
Time Frame: 3-Months Post-Baseline
The CDC HRQOL-14 is a questionnaires that provide a summary score of an individual's overall perceived health status and health-related functional disability
3-Months Post-Baseline
Working Alliance Inventory - Short Revised - Client Version (Wai-sr)
Time Frame: 3-Months Post-Baseline
The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.
3-Months Post-Baseline
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 3-Months Post-Baseline
Client Satisfaction Questionnaire-8© (CSQ-8©) The CSQ-8 is a self-report instrument designed to measure satisfaction with care
3-Months Post-Baseline
Homework Adherence And Competence Scale (Haacs)
Time Frame: Weekly between Baseline and 3-Months Post-Baseline
The Homework Adherence and Competence Scale (HAACS) is a 19-item independent evaluator-rated instrument that assesses therapists' adherence and competence in reviewing, designing, and assigning homework assignments in cognitive behavior therapy. Total scores range from 0 to 30 for Reviewing homework, 0 to 54 for Designing homework, and 0 to 30 for Assigning homework, with higher scores reflecting greater adherence/competence.
Weekly between Baseline and 3-Months Post-Baseline
Assessment of Core CBT Skills (ACCS)
Time Frame: Weekly between Baseline and 3-Months Post-Baseline
The Assessment of Core CBT Skills (ACCS; Muse et al., 2017) measures core general therapeutic and CBT-specific skills required to competently deliver CBT interventions that reflect the current evidence-base for treatment of the patient's presenting problem
Weekly between Baseline and 3-Months Post-Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002555
  • 5R41MH126734-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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