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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

Baseline, 3 Months Post Baseline

Results posted on

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

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

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

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 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.

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

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 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.

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

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 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.

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

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

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

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 Assessment

Population: 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

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 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.

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

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 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.

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

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

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

SECONDARY outcome

Timeframe: Baseline, Post-Trial Therapist Assessment

Population: 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

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
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
1.79 units on a scale
Standard Deviation 0.57
2.16 units on a scale
Standard Deviation 0.65

Adverse Events

Clients - Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Clients - Therapy + Adhere.ly

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Therapists - Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Therapists - Therapy + Adhere.ly

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Bunnell

University of South Florida

Phone: 8139748607

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place