Anxiety, Depression, Depression/Anxiety
Conditions
Keywords
mhealth, mental health, adult mental health, homework, health technology
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.
Interventions
BEHAVIORALTherapy
The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.
BEHAVIORALTherapy + 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.
Sponsors
National Institute of Mental Health (NIMH)
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (Gad-7) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale | 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. |
| Working Alliance Inventory - Short Revised (WAI-SR) | 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. |
| Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index | 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. |
| Assessment of Core CBT Skills (ACCS) - Homework 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. | 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. |
| Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale | 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. |
| Client Satisfaction Questionnaire - 8 (CSQ-8) | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 25 |
| 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. | 8 |
| 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. | 10 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 | 4 | 6 |
Baseline characteristics
| Characteristic | Clients - Therapy | Total | Therapists - Therapy + Adhere.ly | Therapists - Therapy | Clients - Therapy + Adhere.ly |
|---|---|---|---|---|---|
| Age, Continuous | 37.21 years STANDARD_DEVIATION 7.96 | 30.37 years STANDARD_DEVIATION 14.48 | 27.40 years STANDARD_DEVIATION 22.48 | 35.00 years STANDARD_DEVIATION 23.5 | 26.24 years STANDARD_DEVIATION 6.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 12 Participants | 0 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 45 Participants | 10 Participants | 7 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 2 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 37 Participants | 7 Participants | 3 Participants | 17 Participants |
| Region of Enrollment United States | 14 participants | 57 participants | 10 participants | 8 participants | 25 participants |
| Sex: Female, Male Female | 13 Participants | 49 Participants | 9 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 1 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 25 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 14 | 0 / 25 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 14 | 0 / 25 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline, 3 Months Post Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clients - Therapy | Generalized Anxiety Disorder-7 (Gad-7) | Baseline | 14.86 units on a scale | Standard Deviation 3.7 |
| Clients - Therapy | Generalized Anxiety Disorder-7 (Gad-7) | 3 Months Post Baseline | 8.33 units on a scale | Standard Deviation 5.23 |
| Clients - Therapy + Adhere.ly | Generalized Anxiety Disorder-7 (Gad-7) | Baseline | 12.88 units on a scale | Standard Deviation 4.82 |
| Clients - Therapy + Adhere.ly | Generalized Anxiety Disorder-7 (Gad-7) | 3 Months Post Baseline | 7.62 units on a scale | Standard Deviation 4.38 |
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.
Time frame: Baseline, 3 Months Post Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clients - Therapy | Patient Health Questionnaire-8 (PHQ-8) | Baseline | 12.57 units on a scale | Standard Deviation 3.98 |
| Clients - Therapy | Patient Health Questionnaire-8 (PHQ-8) | 3 Months Post Baseline | 7.50 units on a scale | Standard Deviation 5.55 |
| Clients - Therapy + Adhere.ly | Patient Health Questionnaire-8 (PHQ-8) | Baseline | 13.80 units on a scale | Standard Deviation 5.05 |
| Clients - Therapy + Adhere.ly | Patient Health Questionnaire-8 (PHQ-8) | 3 Months Post Baseline | 9.19 units on a scale | Standard Deviation 6.37 |
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.
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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clients - Therapy | Assessment of Core CBT Skills (ACCS) - Cognitive Behavioral Therapy Domain | 15.51 units on a scale | Standard Deviation 3.47 |
| Clients - Therapy + Adhere.ly | Assessment of Core CBT Skills (ACCS) - Cognitive Behavioral Therapy Domain | 14.15 units on a scale | Standard Deviation 4.88 |
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.
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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clients - Therapy | Assessment of Core CBT Skills (ACCS) - Homework Domain | 7.35 units on a scale | Standard Deviation 4.17 |
| Clients - Therapy + Adhere.ly | Assessment of Core CBT Skills (ACCS) - Homework Domain | 10.91 units on a scale | Standard Deviation 3.44 |
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.
Time frame: Baseline, Post-Trial Therapist Assessment
Population: The ATHQ was completed by therapists so data are not provided for clients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapists - Therapy | Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale | Baseline | 2.41 units on a scale | Standard Deviation 1.07 |
| Therapists - Therapy | Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale | Post-Trial Therapist Assessment | 1.79 units on a scale | Standard Deviation 0.57 |
| Therapists - Therapy + Adhere.ly | Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale | Baseline | 2.14 units on a scale | Standard Deviation 0.47 |
| Therapists - Therapy + Adhere.ly | Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale | Post-Trial Therapist Assessment | 2.16 units on a scale | Standard Deviation 0.65 |
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.
Time frame: Baseline, Post-Trial Therapist Assessment
Population: The ATHQ was completed by therapists so data are not provided for clients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapists - Therapy | Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale | Baseline | 4.43 units on a scale | Standard Deviation 0.45 |
| Therapists - Therapy | Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale | Post-Trial Therapist Assessment | 4.08 units on a scale | Standard Deviation 0.56 |
| Therapists - Therapy + Adhere.ly | Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale | Baseline | 4.27 units on a scale | Standard Deviation 0.43 |
| Therapists - Therapy + Adhere.ly | Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale | Post-Trial Therapist Assessment | 4.14 units on a scale | Standard Deviation 0.53 |
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.
Time frame: 3 Months Post Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clients - Therapy | Client Satisfaction Questionnaire - 8 (CSQ-8) | 30.55 units on a scale | Standard Deviation 2.38 |
| Clients - Therapy + Adhere.ly | Client Satisfaction Questionnaire - 8 (CSQ-8) | 28.62 units on a scale | Standard Deviation 4.52 |
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.
Time frame: Baseline, 3 Months Post Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clients - Therapy | Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index | Baseline | 9.71 units on a scale | Standard Deviation 8.15 |
| Clients - Therapy | Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index | 3 Months Post Baseline | 15.42 units on a scale | Standard Deviation 9.59 |
| Clients - Therapy + Adhere.ly | Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index | Baseline | 11.44 units on a scale | Standard Deviation 7.61 |
| Clients - Therapy + Adhere.ly | Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index | 3 Months Post Baseline | 12.38 units on a scale | Standard Deviation 8.95 |
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.
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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clients - Therapy | Homework Rating Scale II (HRS II) | 2.74 units on a scale | Standard Deviation 0.78 |
| Clients - Therapy + Adhere.ly | Homework Rating Scale II (HRS II) | 2.92 units on a scale | Standard Deviation 0.74 |
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.
Time frame: 3 Months Post Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clients - Therapy | Working Alliance Inventory - Short Revised (WAI-SR) | 54.09 units on a scale | Standard Deviation 4.01 |
| Clients - Therapy + Adhere.ly | Working Alliance Inventory - Short Revised (WAI-SR) | 49.91 units on a scale | Standard Deviation 9.94 |