Improving Access to Care: Testing an Integrated Care Mobile Health Intervention

Insomnia Clinical Trial

Official title:

Improving Access to Care: Testing an Integrated Care Mobile Health Intervention to Improve Sleep and Mental Health in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780088
• Other study ID #: 46142
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: April 15, 2021

Study information

• Verified date: August 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the feasibility, effectiveness, and dissemination potential of an innovative strategy for improving access to effective sleep health care for adolescents. The study will test an adaptation of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), a brief sleep intervention with demonstrated efficacy for improving sleep and mental health outcomes in youth.

Description:

This adaptation is designed to address the following key challenges to accessing care: (1) to overcome the challenge of low availability of qualified providers as a barrier to treatment access, we have adapted TranS-C for online and mobile device delivery (referred to as mTranS-C), thereby leveraging the high rates of mobile phone and internet use in adolescents; (2) to further increase access we will disseminate mTranS-C within primary care services, a proven strategy for improving access to behavioral health care; and (3) we focus on low-income communities, where there is a higher prevalence of sleep problems and low access to services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 15, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• age 12-18 years

• a sleep health deficit

• youth has access to a mobile phone or internet

• youth is fluent in English.

Exclusion Criteria:

• current use of medications or herbs with known effects on sleep

• current substance use disorder

• current suicidality/thoughts of death

• thought disorder

• unstable major medical conditions

• current psychotherapy for sleep health deficits

Related Conditions & MeSH terms

• Delayed Sleep Phase
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• mTranS-C
mobile health

Locations

Country	Name	City	State
United States	Gardner Packard Children's Health Center	Atherton	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI)	A validated questionnaire; total score range between 0 and 21, with higher numbers representing worse sleep quality.	baseline to end of treatment (anticipated average exposure 2 months), and month 5
Secondary	Patient Health Questionnaire 9 (PHQ-9)	A validated questionnaire measuring depressive symptom severity. The total score ranges between 0 and 19. Scores are rated as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-19).	baseline to end of treatment (anticipated average exposure 2 months), and month 5
Secondary	Strengths & Difficulties Questionnaire (SDQ)	The Strengths and Difficulties Questionnaire (SDQ) is a validated 25 item behavioral screening questionnaire. Individual items are rated 'Somewhat True' (always scored as 1), 'Not True'(score is typically 0 except when reverse scored) and 'Certainly True' (score is typically 2 except when reverse scored). The SDQ comprise 5 scales (Prosocial, Peer Problems, Hyperactivity, Conduct and Emotional Problems) of 5 items each. For each of the 5 scales the score can range from 0 to 10 if all items were completed. These scores can be scaled up pro-rata if at least 3 items were completed, e.g. a score of 4 based on 3 completed items can be scaled up to a score of 7 (6.67 rounded up) for 5 items. A total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, and is counted as missing of one of the 4 component scores is missing.	baseline and at months 2 and 5