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OpenTrials
Completed

NCT Number: NCT05866185

Improving Adherence to Homework During Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33613, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

Client with self-reported:

  • Active psychotic symptoms (e.g., hallucinations, delusions)
  • Significant cognitive disability.

Treatment and study plan

Therapy

Behavioral

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

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.

Primary outcomes

  1. Generalized Anxiety Disorder-7 (Gad-7)

    Time frame: Baseline, 3 Months Post Baseline

    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.

  2. Patient Health Questionnaire-8 (PHQ-8)

    Time frame: Baseline, 3 Months Post Baseline

    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.

Secondary outcomes

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

    Time frame: Baseline, 3 Months Post Baseline

    The Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index assesses quality of life in terms of the number of days in the past month that clients' feel that their mental health was "not bad." The HRQOL-14 was completed by clients. Respondents report a number from 0 to 30, and the final score indicates better mental health related quality of life.

  2. Homework Rating Scale II (HRS II)

    Time frame: 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.

    The Homework Rating Scale II (HRS II) assesses levels of homework adherence in cognitive behavior therapy. Total scores range from 0 to 4 with higher scores reflecting better homework adherence. The HRS-II was completed by clients each week and total scores were averaged across weeks between Baseline and 3 Months Post Baseline.

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

    Time frame: 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.

    The Assessment of Core Cognitive Behavioral Therapy (CBT) Skills (ACCS) - Cognitive Behavioral Therapy Domain is an observer rated measure of therapist competence in delivering Cognitive Behavioral Therapy-based interventions. Total scores range from 5 to 20 with higher scores reflecting better competence. The ACCS was used to rate 20% of weekly therapy session audio recordings and total scores were averaged across this 20% of sessions.

  4. Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale

    Time frame: Baseline, Post-Trial Therapist Assessment

    The Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale assesses therapist perceptions of the positive effects of using homework assignments in psychotherapy. The ATHQ was completed by therapists. Scores range from 1-5 with higher scores indicating therapist perceptions of better positive effects of homework.

  5. Working Alliance Inventory - Short Revised (WAI-SR)

    Time frame: 3 Months Post Baseline

    The Working Alliance Inventory - Short Revised (WAI-SR) assesses therapeutic alliance, defined as a collaborative relationship between a therapist and client. The WAI-SR was completed by clients about their perceived therapeutic alliance with their therapist. Scores range from 12-60 with higher scores indicating better therapeutic alliance.

  6. Client Satisfaction Questionnaire - 8 (CSQ-8)

    Time frame: 3 Months Post Baseline

    The Client Satisfaction Questionnaire - 8 (CSQ-8) assesses the level of clients' satisfaction with their outpatient mental health services. The CSQ-8 was completed by clients. Scores range from 8-32 with higher scores indicating higher levels of satisfaction.

  7. Assessment of Core CBT Skills (ACCS) - Homework Domain

    Time frame: 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.

    The Assessment of Core Cognitive Behavioral Therapy (CBT) Skills (ACCS) - Homework Domain is an observer rated measure of therapist competence in implementing homework during Cognitive Behavioral Therapy-based interventions. Total scores range from 5 to 20 with higher scores reflecting better competence. The ACCS was used to rate 20% of weekly therapy session audio recordings and total scores were averaged across this 20% of sessions.

  8. Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale

    Time frame: Baseline, Post-Trial Therapist Assessment

    The Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale assesses therapist perceptions of the negative impacts of using homework assignments in psychotherapy. The ATHQ was completed by therapists. Scores range from 1-5 with higher scores indicating therapist perceptions of worse negative impacts of homework.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: Adherely STTR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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