Improving Adherence to Homework During Therapy

Depression Clinical Trial

— Adherely STTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866185
• Other study ID #: 002555
• Secondary ID: 5R41MH126734-02
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: University of South Florida
• Contact: Brian E Bunnell, PhD
• Phone: 8139748607
• Email: bbunnell[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depression/Anxiety
• Depressive Disorder

Intervention

Behavioral:
• Therapy
The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.
• 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.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	3-Months Post-Baseline
Primary	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	Baseline
Primary	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	3-Months Post-Baseline
Secondary	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	Baseline
Secondary	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	3-Months Post-Baseline
Secondary	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.	3-Months Post-Baseline
Secondary	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	3-Months Post-Baseline
Secondary	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.	Weekly between Baseline and 3-Months Post-Baseline
Secondary	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.	Weekly between Baseline and 3-Months Post-Baseline
Secondary	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	Weekly between Baseline and 3-Months Post-Baseline
Secondary	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	Baseline
Secondary	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	3-Months Post-Baseline