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Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma (HEARTS)

Primary Purpose

Obesity, Skin Disease, Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healing HEARTS
Peer Support
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • One or more of the following stigmatized health conditions:
  • Obesity
  • Skin disease (including but not limited to psoriasis, eczema, or vitiligo)
  • Cancer (including but not limited to lung, breast, cervical, colorectal, gynecologic, prostate, or head and neck; may include individuals in remission)
  • HIV
  • Type 1 or type 2 diabetes
  • Chronic pain
  • Reported perceptions of stigma due to health condition (by interview)
  • Reported internalization of health-related stigma, as determined by a score above the midpoint on internalized stigma measure and confirmed by interview

Participants must have availability to attend weekly virtual group meetings for 12 weeks, followed by every-other-week and monthly meetings through 26 weeks, in the evening on a specified weekday. Participants must be willing to actively participate and share information about themselves in the group meetings.

Participants must be able to read, comprehend, and speak English in order to participate in group sessions and complete study questionnaires.

Participation requires an electronic device (computer, tablet, or phone) with video capabilities and internet, wi-fi, or cellular data in order to attend group sessions and complete study questionnaires. Individuals who do not have such devices or internet access will still be eligible to participate. In such cases, screening procedures will be conducted by phone, and randomized participants will be provided with web cameras or internet-enabled devices (and/or provided with pre-paid cellular data) to facilitate participation.

Exclusion Criteria:

  • Current or recent (past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention, or psychiatric hospitalization in the past 6 months
  • Current, active suicidal thoughts or suicide attempt within the past year
  • Current or past thought disorder or psychosis, or unmanaged bipolar disorder
  • Current alcohol/substance use disorder that requires immediate treatment
  • Health-related stigma due primarily to mental illness or substance use, or due to health conditions not specified in inclusion criteria.
  • No reported perceptions or internalization of health-related stigma and/or score below midpoint on internalized stigma measure
  • Unwilling or unable to complete study procedures

Participants with severe progression of disease (e.g., end-of-life) or who are undergoing acute, intensive treatment (such as chemotherapy or radiation therapy) will not be eligible to participate due to expected impacts on HRQOL and greater needs for psychological support than the intervention is intended to provide. Such participants may be eligible after completion of acute treatment or if severe symptoms remit and/or prognosis improves.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Healing HEARTS Intervention

    Peer Support

    Waitlist Control

    Arm Description

    The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology.

    The peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology.

    The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention.

    Outcomes

    Primary Outcome Measures

    Internalized Health-Related Stigma Scale
    Change score on measure adapted from Internalized Stigma of Mental Illness Scale (scale scores range from 1-4, with higher scores indicating greater internalized stigma)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2022
    Last Updated
    October 5, 2022
    Sponsor
    University of Florida
    Collaborators
    National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05561595
    Brief Title
    Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
    Acronym
    HEARTS
    Official Title
    Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    November 2026 (Anticipated)
    Study Completion Date
    February 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Institutes of Health (NIH), National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for helping patients cope with health-related stigma, reducing its internalization, and enhancing patient quality of life.
    Detailed Description
    This randomized controlled trial (RCT) will test in a sample of 195 patients with high levels of internalized health-related stigma the effects of a novel transdiagnostic intervention designed to help patients cope with this stigma and to reduce its internalization. Participants will be randomly assigned to one of three intervention conditions: (1) a group-based counseling intervention designed to target internalized health-related stigma, delivered virtually (i.e., via telehealth); (2) a general peer support group conducted via telehealth without a targeted stigma intervention; or (3) a waitlist control group. The counseling and peer support conditions will provide 12 weekly group sessions, followed by 2 every other week sessions and 2 monthly sessions (16 sessions total over the course of 26 weeks, or 6 months). Participants across all conditions will complete outcome assessment visits at baseline/randomization, week 12, and week 26. The waitlist control group will receive the group counseling intervention (condition #1) after completing the week 26 assessment. The primary trial outcome will be the change in internalized stigma from baseline to week 12 (following the most intensive part of the intervention). Change in internalized stigma from baseline to week 26 will be a secondary outcome to determine lasting effects of the intervention in a maintenance" period with less frequent intervention. Other secondary outcomes will include depression, anxiety, stress, coping, and health-related quality of life (HRQOL)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Skin Disease, Cancer, HIV, Diabetes, Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    195 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healing HEARTS Intervention
    Arm Type
    Experimental
    Arm Description
    The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology.
    Arm Title
    Peer Support
    Arm Type
    Active Comparator
    Arm Description
    The peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology.
    Arm Title
    Waitlist Control
    Arm Type
    No Intervention
    Arm Description
    The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healing HEARTS
    Intervention Description
    Session topics will include: psychoeducation; myths and stereotypes; cognitive distortions and restructuring; coping strategies; interpersonal effectiveness; self-efficacy; mindfulness and self-compassion; acceptance and positive self-image; disclosure and finding support; stigma in health care; and empowerment and advocacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer Support
    Intervention Description
    Peer support groups will cover general topics such as symptom management, stress, and social support. Stigma will not be a formal topic of discussion, and group leaders will be trained to avoid initiating conversations about stigma; however, to capture realistic discussions in peer support groups, participants will not be prohibited from discussing the topic should they bring it up.
    Primary Outcome Measure Information:
    Title
    Internalized Health-Related Stigma Scale
    Description
    Change score on measure adapted from Internalized Stigma of Mental Illness Scale (scale scores range from 1-4, with higher scores indicating greater internalized stigma)
    Time Frame
    Baseline to Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or older One or more of the following stigmatized health conditions: Obesity Skin disease (including but not limited to psoriasis, eczema, or vitiligo) Cancer (including but not limited to lung, breast, cervical, colorectal, gynecologic, prostate, or head and neck; may include individuals in remission) HIV Type 1 or type 2 diabetes Chronic pain Reported perceptions of stigma due to health condition (by interview) Reported internalization of health-related stigma, as determined by a score above the midpoint on internalized stigma measure and confirmed by interview Participants must have availability to attend weekly virtual group meetings for 12 weeks, followed by every-other-week and monthly meetings through 26 weeks, in the evening on a specified weekday. Participants must be willing to actively participate and share information about themselves in the group meetings. Participants must be able to read, comprehend, and speak English in order to participate in group sessions and complete study questionnaires. Participation requires an electronic device (computer, tablet, or phone) with video capabilities and internet, wi-fi, or cellular data in order to attend group sessions and complete study questionnaires. Individuals who do not have such devices or internet access will still be eligible to participate. In such cases, screening procedures will be conducted by phone, and randomized participants will be provided with web cameras or internet-enabled devices (and/or provided with pre-paid cellular data) to facilitate participation. Exclusion Criteria: Current or recent (past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention, or psychiatric hospitalization in the past 6 months Current, active suicidal thoughts or suicide attempt within the past year Current or past thought disorder or psychosis, or unmanaged bipolar disorder Current alcohol/substance use disorder that requires immediate treatment Health-related stigma due primarily to mental illness or substance use, or due to health conditions not specified in inclusion criteria. No reported perceptions or internalization of health-related stigma and/or score below midpoint on internalized stigma measure Unwilling or unable to complete study procedures Participants with severe progression of disease (e.g., end-of-life) or who are undergoing acute, intensive treatment (such as chemotherapy or radiation therapy) will not be eligible to participate due to expected impacts on HRQOL and greater needs for psychological support than the intervention is intended to provide. Such participants may be eligible after completion of acute treatment or if severe symptoms remit and/or prognosis improves.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Pearl, PhD
    Phone
    352-294-5405
    Email
    rebecca.pearl@phhp.ufl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rebecca Pearl, PhD
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be shared via the National Institute of Mental Health (NIMH) Data Archive (NDA; https://nda.nih.gov).
    IPD Sharing Time Frame
    Data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates of January 15th and July 15th.

    Learn more about this trial

    Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

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