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| ID | Type | Description | Link |
|---|---|---|---|
| 5R41MH126734-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy | Active Comparator | Standard regular therapy. |
|
| Therapy + Adhere.ly | Experimental | Standard regular therapy, enhanced with Adhere.ly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy | Behavioral | The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Providers:
Clients:
Exclusion Criteria:
Client with self-reported:
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| Name | Affiliation | Role |
|---|---|---|
| Brian E Bunnell, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33613 | United States |
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While 40 therapists were enrolled in the trial, they were not assigned to a treatment arm until after their first referred client enrolled in the study. Not all therapists referred clients who enrolled in the study. As a result, the number of therapists allocated to a treatment arm differs from the number enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clients - Therapy | Clients assigned to receive standard regular therapy. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
| FG001 | Clients - Therapy + Adhere.ly | Clients assigned to receive standard regular therapy enhanced with Adhere.ly Therapy + Adhere.ly: 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. |
| FG002 | Therapists - Therapy | Therapists assigned to provide standard regular therapy to clients. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
| FG003 | Therapists - Therapy + Adhere.ly | Therapists assigned to provide standard regular therapy enhanced with Adhere.ly to clients. Therapy + Adhere.ly: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 40 therapists were enrolled in the study. A total of 18 providers referred clients that enrolled in the trial and were subsequently randomized to a treatment condition. Data are reported for those providers who were randomized to a treatment condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clients - Therapy | Clients assigned to receive standard regular therapy. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
| BG001 | Clients - Therapy + Adhere.ly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study. The GAD-7 was completed by clients so data are not presented for therapists. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months Post Baseline |
|
Up to 3 months post baseline
Therapists - Therapy and Therapists - Therapy + Adhere.ly arms were not monitored/assessed for deaths and/or adverse events so data are not reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clients - Therapy | Clients assigned to receive standard regular therapy. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Bunnell | University of South Florida | 8139748607 | bbunnell@usf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2024 | Dec 9, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Post-Trial Therapist Assessment |
Clients assigned to receive standard regular therapy enhanced with Adhere.ly Therapy + Adhere.ly: 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. |
| BG002 | Therapists - Therapy | Therapists assigned to provide standard regular therapy to clients. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
| BG003 | Therapists - Therapy + Adhere.ly | Therapists assigned to provide standard regular therapy enhanced with Adhere.ly to clients. Therapy + Adhere.ly: 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Clients - Therapy + Adhere.ly | Clients assigned to receive standard regular therapy enhanced with Adhere.ly Therapy + Adhere.ly: 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. |
| OG002 | Therapists - Therapy | Therapists assigned to provide standard regular therapy to clients. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. |
| OG003 | Therapists - Therapy + Adhere.ly | Therapists assigned to provide standard regular therapy enhanced with Adhere.ly to clients. Therapy + Adhere.ly: 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 | 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. | The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study. The PHQ-8 was completed by clients so data are not presented for therapists. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months Post Baseline |
|
|
|
| Secondary | 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. | The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study. The HRQOL-14 was completed by clients so data are not presented for therapists. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months Post Baseline |
|
|
|
| Secondary | 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. | The number of participants reported here differs from the number of participants assigned to arms in the Participant Flow due to some participants not completing the HRS-II and others being lost to contact and withdrawn from the study. The HRS-II was completed by clients so data are not presented for therapists. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
|
|
| Secondary | 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. | The ACCS was rated for sessions with client participants as the unit of analysis so data are not presented for therapists. Given that 20% of sessions were randomly selected for ratings data are provided only for clients whose sessions were randomly selected. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
|
|
| Secondary | 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. | The ATHQ was completed by therapists so data are not provided for clients. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-Trial Therapist Assessment |
|
|
|
| Secondary | 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. | The number of participants reported here differs from the number of participants assigned to arms in the Participant Flow due to a partial completion of the 3 Months Post Baseline assessment by one participant. The WAI-SR was completed by clients about their perceived therapeutic alliance with their therapist so data are not provided for therapists. | Posted | Mean | Standard Deviation | units on a scale | 3 Months Post Baseline |
|
|
|
| Secondary | 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. | The number of participants reported here differs from the number of participants assigned to arms in the Participant Flow due to a partial completion of the 3 Months Post Baseline assessment by one participant. The CSQ-8 was completed by clients about their satisfaction with therapy so data are not provided for therapists. | Posted | Mean | Standard Deviation | units on a scale | 3 Months Post Baseline |
|
|
|
| Secondary | 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. | The ACCS was rated for sessions with client participants as the unit of analysis so data are not presented for therapists. Given that 20% of sessions were randomly selected for ratings data are provided only for clients whose sessions were randomly selected. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
|
|
| Secondary | 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. | The ATHQ was completed by therapists so data are not provided for clients. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Post-Trial Therapist Assessment |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Clients - Therapy + Adhere.ly | Clients assigned to receive standard regular therapy enhanced with Adhere.ly Therapy + Adhere.ly: 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Therapists - Therapy | Therapists assigned to provide standard regular therapy to clients. Therapy: The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Therapists - Therapy + Adhere.ly | Therapists assigned to provide standard regular therapy enhanced with Adhere.ly to clients. Therapy + Adhere.ly: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Measurements |
|---|---|
|
|
| 3 Months Post Baseline |
|
|
|
| 3 Months Post Baseline |
|
|
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| Post-Trial Therapist Assessment |
|
|
|
| Post-Trial Therapist Assessment |
|
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