Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: supported digital CBTI; Device: digital CBTI

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Tully; Phone Number: 650-498-3084; Email: itully@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Isabelle Tully; Email: itully@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated digital CBTI; Therapists will be trained to integrate digital CBTI alongside routine psychotherapy. Patients will receive integrated digital CBTI	Behavioral: supported digital CBTI; in session support for adherence to and engagement with digital CBTI; Device: digital CBTI; CBTI app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Sleep Research Society Foundation
• Investigators: Principal Investigator: Nicole Gumport, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 68391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No