Strength and Pain-Coping Through Resilience and Knowledge

NCT07228520 | Not Yet Recruiting DMC

• 1 other identifier: IRB00529967
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the SPARK intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.

Conditions

Pain; Depressive Symptoms; Aging

Keywords

Older Adults

Outcome Measures

Primary Outcomes (4)

• Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)

  The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.

  Baseline, 12 weeks and 24 weeks

• Change in Pain Interference as assessed by the PROMIS Pain Interference

  The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference is a six item scale used to measure how much pain interferes with activities. The scores can range from 6-30. Higher scores indicate more pain interference with activities.

  Baseline, 12 weeks and 24 weeks

• Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9)

  The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms.

  Baseline, 12 weeks and 24 weeks

• Change in Depressive Symptoms as assessed by the PROMIS 57

  The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms.

  Baseline, 12 weeks and 24 weeks

Secondary Outcomes (2)

• Change in Physical Function as assessed by the Katz Activities of daily living (ADL)

  Baseline, 12 weeks and 24 weeks

• Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL)

  Baseline, 12 weeks and 24 weeks

Study Arms (2)

SPARK Intervention Arm

EXPERIMENTAL

The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time.

Behavioral: SPARK

Wait List Control Arm

ACTIVE COMPARATOR

Once the intervention group has completed the intervention the wait list control group will complete the intervention.

Behavioral: SPARK

Interventions

SPARK BEHAVIORAL

The SPARK program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks.

SPARK Intervention Arm; Wait List Control Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report pain \>3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
• Live in the community
• Live in Central Maryland
• Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
• Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
• One ADL or IADL limitation

You may not qualify if:

• Hospitalized \> 3 times in the last year
• Participating in physical therapy
• Have a terminal diagnosis (\<1 year expected survival)
• \> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
• Unable to speak or understand English

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Taylor JL, Clair CA, Lee JW, Atkins S, Riser TJ, Szanton SL, McCoy MC, Thorpe RJ Jr, Wang C, Gitlin LN. A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older African American women. Contemp Clin Trials. 2023 Sep;132:107299. doi: 10.1016/j.cct.2023.107299. Epub 2023 Jul 20.

  PMID: 37478967 BACKGROUND

• Taylor JL, Clair CA, Gitlin LN, Atkins S, Bandeen-Roche K, Abshire Saylor M, Hladek MD, Riser TJ, Thorpe RJ Jr, Szanton SL. Acceptability and Feasibility of a Pain and Depressive Symptoms Management Intervention in Middle-Aged and Older African American Women. Innov Aging. 2023 Sep 8;7(10):igad096. doi: 10.1093/geroni/igad096. eCollection 2023.

  PMID: 38094930 RESULT

MeSH Terms

Conditions

Pain; Depression

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Janiece L Taylor, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

• Catherine Clair, MHS

  Johns Hopkins University

  STUDY DIRECTOR

Central Study Contacts

Janiece Taylor, PhD

CONTACT

443-287-4503; jwalke90@jhu.edu

Catherine Clair, MHS

CONTACT

cclair1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician will be responsible for randomization and the investigator and study team will not have knowledge if participants are assigned to intervention group or wait list control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigator will conduct subsequent single blind wait list control design to test the preliminary effects of DAPPER and the feasibility of older African American women integrating strategies to address pain, depression, and frailty that are tailored to the individual into the individual's daily routines.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)