AnxietyAdherely STTRNCT05866185
Improving Adherence to Homework During Therapy
A study testing Therapy and Therapy + Adhere.ly in people with Anxiety and Depression, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Depression/Anxiety
- What is being tested?
- Therapy and Therapy + Adhere.ly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 29 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- Client with self-reported:
- Active psychotic symptoms (e.g., hallucinations, delusions)
- Significant cognitive disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Adherence to Evidence-Based Practice Using an Innovative and Easy-to-Use Health IT Solution
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
- Being tested
- Therapy, Therapy + Adhere.ly
- Keywords
- mhealth, mental health, adult mental health, homework, health technology
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyBehavioural
The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.
Therapy + Adhere.lyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Active comparator | Standard regular therapy. Receives: Behavioral: Therapy |
| Therapy + Adhere.ly | Experimental | Standard regular therapy, enhanced with Adhere.ly Receives: Behavioral: Therapy + Adhere.ly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 Months Post Baseline
Secondary outcomes (8)
Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index
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.
Measured: Baseline, 3 Months Post Baseline
Homework Rating Scale II (HRS II)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, Post-Trial Therapist Assessment
Working Alliance Inventory - Short Revised (WAI-SR)
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.
Measured: 3 Months Post Baseline
Client Satisfaction Questionnaire - 8 (CSQ-8)
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.
Measured: 3 Months Post Baseline
Assessment of Core CBT Skills (ACCS) - Homework Domain
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.
Measured: 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) - Negative Session Impact Scale
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.
Measured: Baseline, Post-Trial Therapist Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Sep 2022
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brian E Bunnell, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866185
- Sponsor's protocol ID
- 002555
- Other IDs
- 5R41MH126734-02
- Acronym
- Adherely STTR
- Status last verified
- Dec 2025
- First submitted
- 10 May 2023
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Evidence-Based Practice Using an Innovative and Easy-to-Use Health IT Solution
- ClinicalTrials.gov ID
- NCT05866185
- Acronym / sponsor ID
- Adherely STTR / 002555
- Conditions
- Anxiety, Depression, Depression/Anxiety
- Keywords
- mhealth, mental health, adult mental health, homework, health technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Posted 15 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy | Active comparator | Behavioral: TherapyStandard regular therapy. |
| Therapy + Adhere.ly | Experimental | Behavioral: Therapy + Adhere.lyStandard regular therapy, enhanced with Adhere.ly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- English-speaking
Key exclusion criteria (3 listed)
- Active psychotic symptoms (e.g., hallucinations, delusions)
- Significant cognitive disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TherapyThe standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. | Behavioural | Therapy |
| Therapy + Adhere.lyParticipants 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. | Behavioural | Therapy + Adhere.ly |
Primary outcome
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.
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.
8 secondary outcomes
Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index
Time frame: Baseline, 3 Months Post Baseline
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.
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.
Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale
Time frame: Baseline, Post-Trial Therapist Assessment
Working Alliance Inventory - Short Revised (WAI-SR)
Time frame: 3 Months Post Baseline
Client Satisfaction Questionnaire - 8 (CSQ-8)
Time frame: 3 Months Post Baseline
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.
Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale
Time frame: Baseline, Post-Trial Therapist Assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian E Bunnell, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy and Therapy + Adhere.ly in people with Anxiety and Depression, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (Gad-7) (time frame: Baseline, 3 Months Post Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.