Improving Adherence to Homework During Therapy

NCT05866185 | Completed Results

• 2 other identifiers: 0025555R41MH126734-02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Depression/Anxiety

Keywords

mhealth; mental health; adult mental health; homework; health technology

Outcome Measures

Primary Outcomes (2)

• Generalized Anxiety Disorder-7 (Gad-7)

  The Generalized Anxiety Disorder Scale-7 (GAD-7) assesses the severity of anxiety symptoms in adults. The GAD-7 was completed by clients about themselves. Scores range from 0 to 21 with higher scores indicating worse anxiety symptom severity. A score of 8 or greater is generally considered to indicate clinically significant anxiety symptom severity.

  Baseline, 3 Months Post Baseline

• Patient Health Questionnaire-8 (PHQ-8)

  The Patient Health Questionnaire-8 (PHQ-8) assesses the severity of depression symptoms in adults. The PHQ-8 was completed by clients about themselves. Scores range from 0 to 28 with higher scores indicating worse depression symptom severity. A score of 10 or greater is generally considered to indicate clinically significant depression symptom severity.

  Baseline, 3 Months Post Baseline

Secondary Outcomes (8)

• Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index

  Baseline, 3 Months Post Baseline

• Homework Rating Scale II (HRS II)

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.

• Assessment of Core CBT Skills (ACCS) - Cognitive Behavioral Therapy Domain

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.

• Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale

  Baseline, Post-Trial Therapist Assessment

• Working Alliance Inventory - Short Revised (WAI-SR)

  3 Months Post Baseline

Study Arms (2)

Therapy

ACTIVE COMPARATOR

Standard regular therapy.

Behavioral: Therapy

Therapy + Adhere.ly

EXPERIMENTAL

Standard regular therapy, enhanced with Adhere.ly

Behavioral: Therapy + Adhere.ly

Interventions

Therapy BEHAVIORAL

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

Therapy

Therapy + Adhere.ly BEHAVIORAL

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.

Therapy + Adhere.ly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 years
• 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

You may not qualify if:

• Client with self-reported:
• Active psychotic symptoms (e.g., hallucinations, delusions)
• Significant cognitive disability.

Sponsors & Collaborators

• University of South Florida: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Results Point of Contact

• Title: Brian Bunnell
• Organization: University of South Florida

bbunnell@usf.edu

8139748607

Study Officials

• Brian E Bunnell, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: September 1, 2022
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)