Improving Adherence to Homework During Therapy

Browse trials for

• Anxiety Disorders 4,868
• Depression 8,057
• Psychological Well-Being 971

Keywords

• mhealth
• mental health
• adult mental health
• homework
• health technology

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 79 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Study arms

• Active comparator
  Therapy

  Standard regular therapy.

  Behavioral: Therapy

• Experimental
  Therapy + Adhere.ly

  Standard regular therapy, enhanced with Adhere.ly

  Behavioral: Therapy + 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.

Primary outcomes

1. 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

2. 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

Secondary outcomes

1. 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

2. 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.

3. 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.

4. 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

5. 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

6. 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

7. 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.

8. 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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Feb 13, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No