Trial Outcomes & Findings for Improving Adherence to Homework During Therapy (NCT NCT05866185)
NCT ID: NCT05866185
Last Updated: 2026-01-15
Results Overview
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.
COMPLETED
NA
79 participants
Baseline, 3 Months Post Baseline
2026-01-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
25
|
8
|
10
|
|
Overall Study
Completed 3-month Post-baseline
|
12
|
21
|
0
|
0
|
|
Overall Study
Completed Post-Trial Therapist Assessment
|
0
|
0
|
4
|
4
|
|
Overall Study
COMPLETED
|
12
|
21
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
4
|
6
|
Baseline Characteristics
Improving Adherence to Homework During Therapy
Baseline characteristics by cohort
| Measure |
Clients - Therapy
n=14 Participants
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.
|
Clients - Therapy + Adhere.ly
n=25 Participants
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.
|
Therapists - Therapy
n=8 Participants
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.
|
Therapists - Therapy + Adhere.ly
n=10 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.21 years
STANDARD_DEVIATION 7.96 • n=9 Participants
|
26.24 years
STANDARD_DEVIATION 6.97 • n=6 Participants
|
35.00 years
STANDARD_DEVIATION 23.50 • n=9 Participants
|
27.40 years
STANDARD_DEVIATION 22.48 • n=205 Participants
|
30.37 years
STANDARD_DEVIATION 14.48 • n=16 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
20 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
9 Participants
n=205 Participants
|
49 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
8 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
12 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
10 Participants
n=205 Participants
|
45 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
13 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
17 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=205 Participants
|
37 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
5 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=9 Participants
|
25 participants
n=6 Participants
|
8 participants
n=9 Participants
|
10 participants
n=205 Participants
|
57 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 Months Post BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=14 Participants
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.
|
Clients - Therapy + Adhere.ly
n=25 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7 (Gad-7)
Baseline
|
14.86 units on a scale
Standard Deviation 3.70
|
12.88 units on a scale
Standard Deviation 4.82
|
—
|
—
|
|
Generalized Anxiety Disorder-7 (Gad-7)
3 Months Post Baseline
|
8.33 units on a scale
Standard Deviation 5.23
|
7.62 units on a scale
Standard Deviation 4.38
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3 Months Post BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=14 Participants
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.
|
Clients - Therapy + Adhere.ly
n=25 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Patient Health Questionnaire-8 (PHQ-8)
Baseline
|
12.57 units on a scale
Standard Deviation 3.98
|
13.80 units on a scale
Standard Deviation 5.05
|
—
|
—
|
|
Patient Health Questionnaire-8 (PHQ-8)
3 Months Post Baseline
|
7.50 units on a scale
Standard Deviation 5.55
|
9.19 units on a scale
Standard Deviation 6.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Months Post BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=14 Participants
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.
|
Clients - Therapy + Adhere.ly
n=25 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Health-Related Quality of Life (HRQOL-14) - Healthy Mental Health Days Index
Baseline
|
9.71 units on a scale
Standard Deviation 8.15
|
11.44 units on a scale
Standard Deviation 7.61
|
—
|
—
|
|
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
|
12.38 units on a scale
Standard Deviation 8.95
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=11 Participants
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.
|
Clients - Therapy + Adhere.ly
n=19 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Homework Rating Scale II (HRS II)
|
2.74 units on a scale
Standard Deviation .78
|
2.92 units on a scale
Standard Deviation .74
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=5 Participants
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.
|
Clients - Therapy + Adhere.ly
n=12 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Assessment of Core CBT Skills (ACCS) - Cognitive Behavioral Therapy Domain
|
15.51 units on a scale
Standard Deviation 3.47
|
14.15 units on a scale
Standard Deviation 4.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Post-Trial Therapist AssessmentPopulation: The ATHQ was completed by therapists so data are not provided for clients.
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.
Outcome measures
| Measure |
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.
|
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.
|
Therapists - Therapy
n=8 Participants
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.
|
Therapists - Therapy + Adhere.ly
n=10 Participants
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.
|
|---|---|---|---|---|
|
Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale
Baseline
|
—
|
—
|
4.43 units on a scale
Standard Deviation 0.45
|
4.27 units on a scale
Standard Deviation 0.43
|
|
Attitudes Toward Homework Questionnaire (ATHQ) - Positive Homework Effect Scale
Post-Trial Therapist Assessment
|
—
|
—
|
4.08 units on a scale
Standard Deviation 0.56
|
4.14 units on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 3 Months Post BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=11 Participants
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.
|
Clients - Therapy + Adhere.ly
n=21 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Working Alliance Inventory - Short Revised (WAI-SR)
|
54.09 units on a scale
Standard Deviation 4.01
|
49.91 units on a scale
Standard Deviation 9.94
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 Months Post BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=11 Participants
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.
|
Clients - Therapy + Adhere.ly
n=21 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Client Satisfaction Questionnaire - 8 (CSQ-8)
|
30.55 units on a scale
Standard Deviation 2.38
|
28.62 units on a scale
Standard Deviation 4.52
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Clients - Therapy
n=5 Participants
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.
|
Clients - Therapy + Adhere.ly
n=12 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Assessment of Core CBT Skills (ACCS) - Homework Domain
|
7.35 units on a scale
Standard Deviation 4.17
|
10.91 units on a scale
Standard Deviation 3.44
|
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SECONDARY outcome
Timeframe: Baseline, Post-Trial Therapist AssessmentPopulation: The ATHQ was completed by therapists so data are not provided for clients.
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.
Outcome measures
| Measure |
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.
|
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.
|
Therapists - Therapy
n=8 Participants
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.
|
Therapists - Therapy + Adhere.ly
n=10 Participants
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.
|
|---|---|---|---|---|
|
Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale
Baseline
|
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2.41 units on a scale
Standard Deviation 1.07
|
2.14 units on a scale
Standard Deviation 0.47
|
|
Attitudes Toward Homework Questionnaire (ATHQ) - Negative Session Impact Scale
Post-Trial Therapist Assessment
|
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1.79 units on a scale
Standard Deviation 0.57
|
2.16 units on a scale
Standard Deviation 0.65
|
Adverse Events
Clients - Therapy
Clients - Therapy + Adhere.ly
Therapists - Therapy
Therapists - Therapy + Adhere.ly
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place