Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy

NCT05814783 | Completed

• 1 other identifier: 68391
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time spent supporting dCBTi

  Through study duration, usually 3 months

Study Arms (1)

Integrated digital CBTI

EXPERIMENTAL

Therapists will be trained to integrate digital CBTI alongside routine psychotherapy. Patients will receive integrated digital CBTI

Behavioral: supported digital CBTI; Device: digital CBTI

Interventions

supported digital CBTI BEHAVIORAL

in session support for adherence to and engagement with digital CBTI

Integrated digital CBTI

digital CBTI DEVICE

CBTI app

Integrated digital CBTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• Sleep Research Society Foundation: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Nicole Gumport, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 18, 2023
• Study Start: August 24, 2023
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)