Improving Adherence to Homework During Therapy

Not Applicable

Recruiting

• Conditions: Anxiety; Depression/Anxiety; Depression
• Interventions: Behavioral: Therapy; Behavioral: Therapy + Adhere.ly

• Registration Number: NCT05866185
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-21
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

Client with self-reported:

• Active psychotic symptoms (e.g., hallucinations, delusions)
• Significant cognitive disability, developmental delays, or pervasive developmental disorder.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapy	Therapy	Standard regular therapy.
Therapy + Adhere.ly	Therapy + Adhere.ly	Standard regular therapy, enhanced with Adhere.ly

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Attitudes Toward Homework Questionnaire (ATHQ)	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
Working Alliance Inventory - Short Revised - Client Version (Wai-sr)	3-Months Post-Baseline	The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance.
Homework Rating Scale II (HRS II)	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.
Health-Related Quality of Life (CDC HRQOL-14)	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
Homework Adherence And Competence Scale (Haacs)	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.
Client Satisfaction Questionnaire (CSQ-8)	3-Months Post-Baseline	Client Satisfaction Questionnaire-8© (CSQ-8©) The CSQ-8 is a self-report instrument designed to measure satisfaction with care
Assessment of Core CBT Skills (ACCS)	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

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States