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NCT Number: NCT03871270

The National Institutes of Health Measure of Healing Experience of All Life Stressors

NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. The factorial structure of the tool has been recently re-examined with 200 patients. The three main factors are: Connection (including religious, spiritual, interpersonal), Reflection/ Introspection, and Trust/Acceptance.

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Key information

Conditions

Severe Chronic Illness Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Health

Bethesda, Maryland, 20892, United States

About this study

At the Clinical Center Pain and Palliative Care Service (PPCS) we have developed a pscyho-social-spiritual measure, the Healing Experience in all Life Stressors (HEALS), that focuses on the healing experience in people with severe and life limiting illness. We have validated this tool further in order to be able to identify those individuals who may benefit from additional interventions to cope with their illness and even assist them in reaching a healing experience that is possible even in the midst of their unfavorable circumstances. Identification of vulnerable individuals as well individuals who do have transformative experience after being diagnosed with severe and life limiting illness, has far-reaching impact on the quality of patient care for the very sick patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18 or above
  • The ability to read and write in English
  • The presence or history of a serious and/or life-threatening disease

Treatment and study plan

Primary outcomes

  1. National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS)

    Time frame: 7 months

    Based on our validation study (Ameli et.al., 2018), we now propose a 35-item, three-factor NIH-HEALS as a measure of psycho-social-spiritual healing. These three factors include: Connection, Reflection & Introspection, and Trust & Acceptance.

  2. Self Integration Scale (SIS) -V2

    Time frame: 7 months

    SIS is an 18 item self report measure with 2 factors: Healed and Co-dependent. As predicted NIH-HEALS positively correlated with the Healed and negative correlated with the Co-dependent factors.

  3. Functional Assessment of Chronic Illness Therapy-Spiritual well being (FACIT-SP)

    Time frame: 7 months

    FACIT-SP is a 12 item self report that measures spiritual well being and is a part of the larger FACIT measurement system (www.FACIT.org). A 3 factor structure has been reported with cancer patients and include meaning, peace, and faith. As predicted, NIH-HEALS correlated positively with these 3 factors.

  4. Mindful Attention Awareness Scale (MAAS)

    Time frame: 7 months

    MAAS is a self report measure of trait mindfulness with 15 items. As predicted NIH-HEALS correlated positively with MAAS.

  5. The Connor-Davidson Resilience Scale (CD-RISC) (10 item version)

    Time frame: 7 months

    CD-RSIC is a 10 item self-report measure of resilience. As predicted NIH-HEALS positively correlated with CD-RISC

  6. Life Events Checklist 5 (LEC-5) (standard self-report)

    Time frame: 7 months

    LEC-5 is a 17 item self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items.

  7. Demographic Questionnaire (DQ)

    Time frame: 7 months

    DQ collected information on gender, age, ethnicity, race, marital status, religious affiliation, education, employment status, medical diagnosis, length of illness, severity of illness, psychiatric co-morbidity, perceived stress level, perceived level of social support, overall health status, and overall quality of life.

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Official study title

The National Institutes of Health Measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor Analysis and Validation

Acronym: NIH-HEALS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2019
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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