Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy

Insomnia Clinical Trial

Official title:

A Clinician Training Program to Integrate Digital Cognitive Behavior Therapy for Insomnia Into Routine Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814783
• Other study ID #: 68391
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: Isabelle Tully
• Phone: 650-498-3084
• Email: itully[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Therapist Criteria:

Inclusion Criteria:

• Licensed mental health clinicians

• Have a clinical care model that includes seeing patients weekly or biweekly

• Provide therapy in English

• Treat patients with depression and/or anxiety

• Can identify 1-2 patients who are willing to consent to be training cases.

Exclusion Criteria:

• Not meeting all of the inclusion criteria

Patient Criteria:

Inclusion Criteria:

• Aged 18+ years old

• Receive weekly or biweekly therapy from participating study therapist

• Identify improving sleep as a goal for treatment and experience insomnia (Insomnia Severity Index score greater than or equal to 10)

• Have daily access to a smartphone, tablet, or computer

• Can read, write, and speak in English

Exclusion Criteria:

• Conditions known to make study treatment less effective (e.g., current chronic medication use known to interfere with sleep, alcohol or substance use disorder, thought disorder)

• Conditions for which dCBTi is a safety risk (e.g., bipolar disorder, excessive daytime sleepiness)

• Current psychotherapy for insomnia

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• supported digital CBTI
in session support for adherence to and engagement with digital CBTI

Device:
• digital CBTI
CBTI app

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Sleep Research Society Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index (ISI)	Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity, patient outcome.	Pre-treatment and immediately post-treatment (treatment phase is 12 weeks)
Primary	Change in Knowledge of Supporting Integrated dCBTi	Therapist outcome assessing knowledge gained during training program measured via a study-specific questionnaire on which higher scores indicating more knowledge	Pre-training (at the start of the one day training) and immediately post-training (at the end of the one day training)
Secondary	Time spent supporting dCBTi	From a structured post-session note completed by the therapist, therapist-reported how much time spent devoted to supporting dCBTI	Through study duration, usually 3 months