Improving Adherence to Homework During Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Depression, Depression/Anxiety

Intervention / Treatment
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* Behavioral: Therapy
* Behavioral: Therapy + Adhere.ly


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapy<br>Standard regular therapy. | Behavioral: Therapy<br>* The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.<br>|
| Experimental: Therapy + Adhere.ly<br>Standard regular therapy, enhanced with Adhere.ly | Behavioral: Therapy + Adhere.ly<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mhealth, mental health, adult mental health, homework, health technology