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Improving Adherence to Homework During Therapy (Adherely STTR)

Primary Purpose

Anxiety, Depression, Depression/Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy
Therapy + Adhere.ly
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring mhealth, mental health, adult mental health, homework, health technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Therapy

Therapy + Adhere.ly

Arm Description

Standard regular therapy.

Standard regular therapy, enhanced with Adhere.ly

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder-7 (Gad-7)
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
Generalized Anxiety Disorder-7 (Gad-7)
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
Patient Health Questionnaire-8 (Phq-8)
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
Patient Health Questionnaire-8 (Phq-8)
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

Secondary Outcome Measures

Health-Related Quality of Life (CDC HRQOL-14)
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
Health-Related Quality of Life (CDC HRQOL-14)
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
Working Alliance Inventory - Short Revised - Client Version (Wai-sr)
The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.
Client Satisfaction Questionnaire (CSQ-8)
Client Satisfaction Questionnaire-8© (CSQ-8©) The CSQ-8 is a self-report instrument designed to measure satisfaction with care
Homework Rating Scale II (HRS II)
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.
Homework Adherence And Competence Scale (Haacs)
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.
Assessment of Core CBT Skills (ACCS)
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
Attitudes Toward Homework Questionnaire (ATHQ)
A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy
Attitudes Toward Homework Questionnaire (ATHQ)
A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy

Full Information

First Posted
May 10, 2023
Last Updated
August 15, 2023
Sponsor
University of South Florida
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05866185
Brief Title
Improving Adherence to Homework During Therapy
Acronym
Adherely STTR
Official Title
Improving Adherence to Evidence-Based Practice Using an Innovative and Easy-to-Use Health IT Solution
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Depression/Anxiety
Keywords
mhealth, mental health, adult mental health, homework, health technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapy
Arm Type
Active Comparator
Arm Description
Standard regular therapy.
Arm Title
Therapy + Adhere.ly
Arm Type
Experimental
Arm Description
Standard regular therapy, enhanced with Adhere.ly
Intervention Type
Behavioral
Intervention Name(s)
Therapy
Intervention Description
The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.
Intervention Type
Behavioral
Intervention Name(s)
Therapy + Adhere.ly
Intervention Description
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.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (Gad-7)
Description
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
Time Frame
Baseline
Title
Generalized Anxiety Disorder-7 (Gad-7)
Description
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
Time Frame
3-Months Post-Baseline
Title
Patient Health Questionnaire-8 (Phq-8)
Description
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
Time Frame
Baseline
Title
Patient Health Questionnaire-8 (Phq-8)
Description
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
Time Frame
3-Months Post-Baseline
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life (CDC HRQOL-14)
Description
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
Time Frame
Baseline
Title
Health-Related Quality of Life (CDC HRQOL-14)
Description
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
Time Frame
3-Months Post-Baseline
Title
Working Alliance Inventory - Short Revised - Client Version (Wai-sr)
Description
The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.
Time Frame
3-Months Post-Baseline
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Client Satisfaction Questionnaire-8© (CSQ-8©) The CSQ-8 is a self-report instrument designed to measure satisfaction with care
Time Frame
3-Months Post-Baseline
Title
Homework Rating Scale II (HRS II)
Description
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.
Time Frame
Weekly between Baseline and 3-Months Post-Baseline
Title
Homework Adherence And Competence Scale (Haacs)
Description
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.
Time Frame
Weekly between Baseline and 3-Months Post-Baseline
Title
Assessment of Core CBT Skills (ACCS)
Description
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
Time Frame
Weekly between Baseline and 3-Months Post-Baseline
Title
Attitudes Toward Homework Questionnaire (ATHQ)
Description
A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy
Time Frame
Baseline
Title
Attitudes Toward Homework Questionnaire (ATHQ)
Description
A self-report assessing practitioners' demographic characteristics, use of homework assignments and attitudes towards the use of homework assignments in psychotherapy
Time Frame
3-Months Post-Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian E Bunnell, PhD
Phone
8139748607
Email
bbunnell@usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Janelle F Barrera, MPH
Phone
8136442674
Email
jfb@usf.edu
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janelle F Barrera Ikan, MPH
Phone
813-644-2674
Email
jfb@usf.edu
First Name & Middle Initial & Last Name & Degree
Brian E Bunnell, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Adherence to Homework During Therapy

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