Back to resultsClinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy
Primary Purpose
Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
supported digital CBTI
digital CBTI
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrated digital CBTI
Arm Description
Therapists will be trained to integrate digital CBTI alongside routine psychotherapy. Patients will receive integrated digital CBTI
Outcomes
Primary Outcome Measures
Change in Insomnia Severity Index (ISI)
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity, patient outcome.
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
Secondary Outcome Measures
Time spent supporting dCBTi
From a structured post-session note completed by the therapist, therapist-reported how much time spent devoted to supporting dCBTI
Full Information
NCT ID
NCT05814783
First Posted
March 1, 2023
Last Updated
August 24, 2023
Sponsor
Stanford University
Collaborators
Sleep Research Society Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05814783
Brief Title
Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy
Official Title
A Clinician Training Program to Integrate Digital Cognitive Behavior Therapy for Insomnia Into Routine Psychotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Sleep Research Society Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrated digital CBTI
Arm Type
Experimental
Arm Description
Therapists will be trained to integrate digital CBTI alongside routine psychotherapy. Patients will receive integrated digital CBTI
Intervention Type
Behavioral
Intervention Name(s)
supported digital CBTI
Intervention Description
in session support for adherence to and engagement with digital CBTI
Intervention Type
Device
Intervention Name(s)
digital CBTI
Intervention Description
CBTI app
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index (ISI)
Description
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity, patient outcome.
Time Frame
Pre-treatment and immediately post-treatment (treatment phase is 12 weeks)
Title
Change in Knowledge of Supporting Integrated dCBTi
Description
Therapist outcome assessing knowledge gained during training program measured via a study-specific questionnaire on which higher scores indicating more knowledge
Time Frame
Pre-training (at the start of the one day training) and immediately post-training (at the end of the one day training)
Secondary Outcome Measure Information:
Title
Time spent supporting dCBTi
Description
From a structured post-session note completed by the therapist, therapist-reported how much time spent devoted to supporting dCBTI
Time Frame
Through study duration, usually 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Tully
Phone
650-498-3084
Email
itully@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Gumport, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Tully
Email
itully@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy
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