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

Completed

• Conditions: Severe Chronic Illness

• Registration Number: NCT03871270
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-15
• Primary Completion: 2017-09-21
• Study Completion: 2017-12-31
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self Integration Scale (SIS) -V2	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.
Mindful Attention Awareness Scale (MAAS)	7 months	MAAS is a self report measure of trait mindfulness with 15 items. As predicted NIH-HEALS correlated positively with MAAS.
The Connor-Davidson Resilience Scale (CD-RISC) (10 item version)	7 months	CD-RSIC is a 10 item self-report measure of resilience. As predicted NIH-HEALS positively correlated with CD-RISC
National Institutes of Health- Healing Experience of All Life Stressors (NIH-HEALS)	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.
Functional Assessment of Chronic Illness Therapy-Spiritual well being (FACIT-SP)	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.
Life Events Checklist 5 (LEC-5) (standard self-report)	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.
Demographic Questionnaire (DQ)	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.

Trial Locations

Locations (1)

National Institute of Health; 🇺🇸 Bethesda, Maryland, United States