Leveraging Telepsychology and Behavioral Economics to Increase Fidelity to CBT

NCT06601062 | Enrolling By Invitation DMC

• 1 other identifier: R34MH135965
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop and test a telehealth tool intended to support community mental health clinicians to deliver cognitive behavioral therapy (CBT). The main aims of the study are to:

1. 1.Collaborate with clinicians and supervisors to design an accessible prototype to increase clinician use of CBT in community mental health settings through focus groups, interviews, and surveys.
2. 2.Adapt the initial model through feedback from clinicians and their patients who will be asked to test the tool then complete interviews and surveys.
3. 3.Test the model with clinicians and their patients who will be asked to use the tool for several weeks.
4. 4.Evaluate the acceptability and feasibility of using the tool in a pilot trial through surveys and interviews.

Conditions

Implementation Science

Outcome Measures

Primary Outcomes (4)

• Acceptability of Tele-BE

  Acceptability of Intervention Measure: A 4-item, psychometrically-validated measure that indexes the extent to which stakeholders believe an implementation strategy is acceptable Qualitative Interview

  Week of sessions 1, 5, 9, and 12

• Feasibility of Tele-BE

  Feasibility of Intervention Measure; A 4-tem, psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is feasible Web Analytics (i.e., clinician use of Tele-BE features)

  Week of sessions 1, 5, 9, and 12

• Usability of Tele-BE

  \- System Usability Scale (SUS): A 10-item questionnaire on a 5-point scale from 1=Strongly disagree to 5=Strongly agree which measures the usability of a system (in this case, Tele-BE).

  Week of sessions 1, 5, 9, and 12

• Clinician Fidelity to CBT Structural Components

  Cognitive Therapy Rating Scale (CTRS): Clinician fidelity to structural components will be captured via direct observation to each of the 6 components of interest: ((1) progress monitoring with evidence-based assessment tools, (2) agenda setting guided by shared decision-making, (3) out-of-session practice ("homework") review, (4) skill instruction, (5) skill practice, and (6) homework planning. Items will be coded using adapted items of the CTRS, a gold-standard CBT fidelity measure that has a subscale designed to measure structural components

  Weekly over the trial period (approximately 12 sessions, up to 16 weeks)

Secondary Outcomes (4)

• Clinician intentions to use the 6 structural components of EBPs of interest

  Week of sessions 1, 5, 9, and 12

• Clinician attitudes, norms, and self-efficacy (i.e., determinants of intentions) to use the 6 structural components of EBPs of interest

  Week of sessions 1, 5, 9, and 12

• Patient clinical symptoms

  Week of sessions 1, 5, 9, and 12

• Therapeutic alliance

  Week of sessions 1, 5, 9, and 12

Other Outcomes (4)

• contextual factors

  after the trial period (approximately 12 sessions, up to 16 weeks)

• Edward's Social Desirability Scale

  Clinician Baseline (week of session 1)

• Modified Cognitive Therapy Knowledge Quiz

  Clinician Baseline (week of session 1)

Study Arms (2)

Treatment as usual

NO INTERVENTION

Clinicians will deliver cognitive behavioral therapy as usual, as consistent with routine clinic practices, to patients receiving telehealth services

Tele-BE

EXPERIMENTAL

Clinicians will deliver cognitive behavioral therapy as usual, as consistent with routine clinic practices, with the support of the Tele-BE platform, to patients receiving telehealth services

Device: Tele-BE

Interventions

Tele-BE DEVICE

Clinicians and their patients use the newly developed telehealth tool to support their use of CBT during session

Tele-BE

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Prototyping open trial phase:
• Clinician Participants
• Clinician is an outpatient mental health clinician in the City of Philadelphia trained in transdiagnostic CBT through the Penn Collaborative for CBT and Implementation Science
• Clinician has completed the 22-hour intensive CBT workshop through the BCI or equivalent CBT training
• Clinician provides direct mental health services to a treatment-seeking population via telehealth
• Proficient in English language
• Has access to a computer with internet connectivity
• Patient Participants
• Patient is 14 years or older
• Patient is receiving CBT from a participating clinician
• Patient is able to provide informed consent (or if the client is between the ages of 14-17, the client is able to assent and has a legal guardian who is able to provide consent)
• Proficient in English language
• Patient has had at least one prior telehealth therapy session with enrolled therapist
• Has access to a computer with internet connectivity or smartphone through which they regularly attend telehealth therapy sessions
• Pilot randomized controlled trial phase:

You may not qualify if:

• Prototyping open trial phase:
• Clinician Participants - Clinician does not provide any telehealth services.
• Patient Participants
• Patients will be excluded if they are unable to adequately consent to study procedures. For example, clients may be excluded if they are at imminent risk for suicide or homicide requiring hospitalization.
• Youth under the age of 18 will be excluded from the study if they do not have an available legal guardian who is able to provide consent for their study participation (e.g., the state has legal custody of the youth).
• Patients under the age of 14 will be excluded
• Pilot randomized controlled trial phase: Participants will not be excluded based on sex, demographics, and or past experience.
• Clinician Participants
• \- Clinician does not provide telehealth services to at least 2 individuals on their caseload.
• Patient Participants
• Patients will be excluded if they are unable to adequately consent to study procedures. For example, clients may be excluded if they are at imminent risk for suicide or homicide requiring hospitalization or are experiencing any cognitive impairment that prevents them from participating in therapy on the day their session is to be recorded.
• Youth under the age of 18 will be excluded from the study if they do not have an available legal guardian who is able to provide consent for their study participation (e.g., the state has legal custody of the youth).
• Patients under the age of 14 will be excluded

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Becker-Haimes EM, Mandell DS, Kuo PB, Lynch KG, Brady M, Young S, Creed TA. Behavioral Nudges to Enhance Fidelity in Telehealth Sessions (BENEFITS): Protocol for Developing and Pilot Testing a Telehealth Tool to Improve Cognitive Behavioral Therapy Implementation. JMIR Res Protoc. 2025 Sep 18;14:e76035. doi: 10.2196/76035.

  PMID: 40966682 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 19, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)