Horyzons: Implementation in Clinical Practice

February 29, 2024 updated by: University of North Carolina, Chapel Hill
A clinical trial investigating the feasibility and acceptability of implementing a moderated online social media platform with therapeutic content, Horyzons, as a part of care received at first-episode psychosis (FEP) clinics across North Carolina. Clients between the ages of 18 and 35 who are enrolled at one of the 4 FEP clinics in North Carolina will be considered for enrollment in the trial. Cohort 1 participants will have access to the platform for 3 months and cohort 2 participants will have access to the platform for 6 months. All interventions and assessments will be completed virtually/remotely due to the global pandemic.

Study Overview

Detailed Description

Purpose: Our primary objective is to examine the feasibility and acceptability of implementing Horyzons as a part of care received at first-episode psychosis clinics across North Carolina. Our primary aim is to understand how to implement a novel treatment approach as part of routine clinical practice with guidance, assistance, and feedback from service providers (e.g., clinicians, peer support specialists) embedded within the clinic. Our second aim is to assess the extent to which clients engage with the platform (i.e., site usage information) and their thoughts and opinions of Horyzons (i.e., feedback and suggestions). Our third aim is to assess change in psychological measures across the three month study period.

Participants:

Cohort 1:

30 individuals with first episode psychosis (FEP) 20 clinicians and/or peer support specialists from the FEP clinics

Cohort 2:

60 individuals with FEP 20 clinicians and/or peer support specialists from the FEP clinics

Procedures (methods): FEP participants will be recruited over a 16-week period at their respective first episode clinic. Site usage information as well as feedback about their experience will be collected from participants through the Horyzons platform. Site usage information (e.g., number of posts/comments made on the site, the number and types of 'Journeys' or 'Tracks' (therapeutic content) completed by participants, etc.) will be collected automatically through the Horyzons platform. This trial will last three months for cohort 1 and six months for cohort 2. Before being given access to Horyzons, a research assistant, peer support specialist, or clinician will provide instructions and guidance for using the site (i.e., Horyzons induction). Feedback will be collected from participants at the end of the active study period.

Service providers (i.e., clinicians and/or peer support specialists) will be asked to provide feedback about their perceptions of their clients' responses to engaging in Horyzons for the 3-month (cohort 1) or the 6-month (cohort 2) period. Clinicians and peer support specialists will also be asked about their experience integrating the psychosocial intervention in the clinic. Items will include challenges to clinic-wide implementation as well as their feedback to overcome/reduce the impact of these barriers if Horyzons were to be provided as part of routine clinical care in the future. Clinicians and peer support specialists will be interviewed in 1-2 focus groups (depending on schedule and availability) for which these individuals will be compensated.

As Horyzons involves therapeutic content and is designed to improve psychological outcomes such as loneliness and social support, this service is considered part of the clinical care provided to individuals by their respective FEP clinic. As such, participants will not be compensated for their involvement in the platform. Site usage information will be collected automatically through the Horyzons site. However, clients will be compensated for providing feedback about their experience with Horyzons as well as for completing the assessment portion of the study onboarding process.

Finally, Horyzons will be monitored daily (two hours per weekday and one hour per weekend day) by trained peer support specialists, master's level clinicians, and/or graduate students in the Department of Psychology and Neuroscience at UNC. The principal investigator, David Penn, will lead weekly supervision calls to ensure appropriate care and support of clients involved in this project, to discuss case conceptualization and suggestions for engaging clients in the platform, as well as to monitor any potential safety concerns. All clinically-relevant information will be shared with the first episode clinicians involved in participants' mental health care.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bryan J Stiles, BA
  • Phone Number: 360-480-9344
  • Email: stilesb@unc.edu

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clients must be between the ages of 18 and 35
  • Clients must have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or Unspecified Schizophrenia Spectrum or Other Psychotic disorder
  • Clients must be receiving services at one of the four FEP clinics in North Carolina (OASIS, Encompass, Eagle, or SHORE)
  • Clients must not have had thoughts of harming themselves in the month before enrollment
  • Clients must not have been hospitalized for psychiatric reasons in the three months before enrollment
  • Clients must not have had a psychiatric medication change in the month before enrollment
  • Clients must have access to the internet through a phone, tablet, or computer

Exclusion Criteria:

  • Clients who do not speak English will not be considered for enrollment
  • Clients with legal guardians (LARs) will not be considered for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FEP Clients
Approximately 90 first episode psychosis (FEP) clients recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in the online platform Horyzons for 3 months (cohort 1) or 6 months (cohort 2) as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study.
Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Other: FEP Clinicians
Approximately 40 providers (clinicians and peer support specialists) affiliated with First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in a focus group discussing the implementation and integration of Horyzons into their care routine with clients who participated in the study.
Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in UCLA Loneliness Scale Score (Both Cohorts)
Time Frame: up to 6 months
The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit. The UCLA Loneliness Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts)
Time Frame: up to 6 months
The MOS Social Support Survey is a 19 item scale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 19 to 95. Higher scores reflect higher feelings of social support (more perceived social support). The MOS Social Support Survey is a part of the PhenX Toolkit. The MOS Social Support Survey is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts)
Time Frame: up to 6 months
The Social Interaction Anxiety Scale (SIAS) is a 20 item scale. Answers are on a 4 point scale starting at 0 with options "none at all", "slightly", "moderately", "very", and "extremely". Possible scores range from 0 to 80. Higher scores reflect higher levels of social anxiety. Scoring a 43 or higher may indicate a diagnosis of social anxiety, and scores between 34 and 42 may indicate social phobia(s). The SIAS is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) is an 18 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 18 to 108. Higher scores reflect higher levels of psychological wellbeing. The Psychological Wellbeing Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Emotional/Informational Support Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The MOS Social Support Survey - Emotional/informational support subscale is an 8 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 8 to 40. Higher scores reflect higher feelings of emotional and informational social support (more perceived emotional and informational social support). The MOS Social Support Survey - Emotional/informational support subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Tangible Support Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The MOS Social Support Survey - Tangible support subscale is a 4 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 4 to 20. Higher scores reflect higher feelings of tangible social support (more perceived tangible social support). The MOS Social Support Survey - Tangible support subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Affectionate Support Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The MOS Social Support Survey - Affectionate support subscale is a 3 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 3 to 15. Higher scores reflect higher feelings of affectionate social support (more perceived affectionate social support). The MOS Social Support Survey - Affectionate support subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Positive Social Interaction Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The MOS Social Support Survey - Positive social interaction subscale is a 3 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 3 to 15. Higher scores reflect higher feelings of positive social interaction (more perceived positive social interaction). The MOS Social Support Survey - Positive social interaction subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Environmental Mastery Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) - Environmental Mastery Subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of environmental mastery. The MOS Social Support Survey - Environmental Mastery subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Personal Growth Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) - Personal Growth subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of personal growth. The Psychological Wellbeing Scale - Personal Growth subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Self-Acceptance Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) - Self-Acceptance subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher feelings of self-acceptance. The Psychological Wellbeing Scale - Self-Acceptance subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Autonomy Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) - Autonomy Subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of autonomy. The Psychological Wellbeing Scale - Autonomy subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Positive Relationships Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) - Positive Relationships subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of positive relationships. The Psychological Wellbeing Scale - Positive Relationships subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Psychological Wellbeing Scale Short Form - Purpose in Life Subscale Score (Both Cohorts)
Time Frame: up to 6 months
The Psychological Wellbeing Scale (Short Form) - Purpose in Life subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher feelings of purpose in life. The Psychological Wellbeing Scale - Purpose in Life subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Qualitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)
Time Frame: up to 6 months
This qualitative data will be collected post-treatment from clients and clinicians. Focus groups and individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions. Feedback is elicited at post-treatment in both cohort 1 (Month 3) and cohort 2 (Month 6).
up to 6 months
Quantitative Summaries of Participant Experience in Post-Treatment Feedback (Both Cohorts)
Time Frame: up to 6 months
This quantitative data will be collected post-treatment from clients and clinicians. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with higher scores reflecting a more positive experience. Frequency counts will be included here. Feedback is elicited at post-treatment in both cohort 1 (Month 3) and cohort 2 (Month 6).
up to 6 months
Mean Change in Questionnaire about the Process of Recovery - Total Score (Cohort 2 Only)
Time Frame: up to 6 months
The Questionnaire about the Process of Recovery (QPR) - Total Score is a 15-item scale. Answers are rated on a 5-point scale with options "disagree strongly", "disagree", "neither agree nor disagree", "agree", and "agree strongly. Possible scores range from 0 to 60. Higher scores are indicative of recovery. The QPR is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Modified Colorado Symptom Index - Total Score (Cohort 2 Only)
Time Frame: up to 6 months
The Modified Colorado Symptom Index - Total Score is a 14-item scale. Answers are rated on a 4-point scale with options "not at all", "once during the month", "several times during the month", "several times a week", and "at least every day". Possible scores range from 0 to 56. Higher scores indicate greater emotional distress. The Modified Colorado Symptom Index is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Social Anxiety Scale for Social Media Users - Total Score (Cohort 2 Only)
Time Frame: up to 6 months
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Total Score is a 21-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 21 to 105. Higher scores reflect greater anxiety related to social media usage. The SAS-SMU is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Social Anxiety Scale for Social Media Users - Shared Content Anxiety Subscale Score (Cohort 2 Only)
Time Frame: up to 6 months
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Shared Content Anxiety subscale is a 7-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 7 to 35. Higher scores reflect greater anxiety related to sharing or creating content on social media. The SAS-SMU - Shared Content Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Social Anxiety Scale for Social Media Users - Privacy Concern Anxiety Subscale Score (Cohort 2 Only)
Time Frame: up to 6 months
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Privacy Concern Anxiety subscale is a 5-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 5 to 25. Higher scores reflect greater anxiety related to privacy concerns on social media. The SAS-SMU - Privacy Concern Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Social Anxiety Scale for Social Media Users - Interaction Anxiety Subscale Score (Cohort 2 Only)
Time Frame: up to 6 months
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Interaction Anxiety subscale is a 6-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 6 to 30. Higher scores reflect greater anxiety related to social interactions over social media. The SAS-SMU - Interaction Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Social Anxiety Scale for Social Media Users - Self-Evaluation Anxiety Subscale Score (Cohort 2 Only)
Time Frame: up to 6 months
The Social Anxiety Scale for Social Media Users (SAS-SMU) - Self-Evaluation Anxiety subscale is a 3-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 3 to 15. Higher scores reflect greater anxiety related to negative self-evaluation. The SAS-SMU - Self-Evaluation Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).
up to 6 months
Mean Change in Perceived Autonomy Support Scale - Total Score (Both Cohorts)
Time Frame: up to 20 weeks
The Perceived Autonomy Support Scale - Total Score is a 6-item scale. Answer are on a 7-point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "neutral", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 6 to 42. Higher scores reflect greater perceived autonomy support. The Perceived Autonomy Support Scale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).
up to 20 weeks
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts)
Time Frame: up to 20 weeks
The Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score is a 12-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 12 to 60 (summed) or 1 to 5 (averaged). Higher scores reflect greater therapeutic alliance. The WAI-I is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).
up to 20 weeks
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts)
Time Frame: up to 20 weeks
The Working Alliance Inventory for Guided Internet Interventions - Bond subscale score is a 4-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 4 to 20 (summed) or 1 to 5 (averaged). Higher scores reflect greater bond with a clinician. The WAI-I - Bond subscale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).
up to 20 weeks
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts)
Time Frame: up to 20 weeks
The Working Alliance Inventory for Guided Internet Interventions - Goal/Task Score is an 8-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 8 to 40 (summed) or 1 to 5 (averaged). Higher scores reflect greater shared goals and tasks with a clinician. The WAI-I - Goal/Task subscale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).
up to 20 weeks
Mean Change in Twente Engagement with E-health Technologies Scale - Total Score (Cohort 2 Only)
Time Frame: up to 6 months
The Twente Engagement with E-health Technologies Scale - Total Score is a 9-item scale. Answers are on a 5-point scale with options "strongly disagree", "disagree", "neutral", "agree", and "strongly agree". Possible scores range from 0 to 36. Higher scores reflect greater engagement. The Twente Engagement with E-health Technologies Scale is administered in only cohort 2 (Baseline, 1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months).
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Penn, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Diana Perkins, MD, MPH, University of North Carolina, Chapel Hill - School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

9 to 36 months following publication

IPD Sharing Access Criteria

Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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