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Depressive Symptoms / Depression / PRIME Intervention · Interventional Study
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a terminated pilot study of a home-based behavioral intervention (PRIME) for chronic pain and depression in older women with disabilities. No results are reported in this registry entry. The study enrolled only 9 participants and was terminated, precluding any meaningful inference about efficacy.
Interventional, Randomized, Crossover, Double masking, Treatment purpose. Pain, Chronic, Depressive Symptoms, Depression, Disability Physical; Female; age from 50 Years. Intervention: Wait List Control Group; Intervention Group. n = 9. 1 site: United States.
This is a registry record for a terminated pilot study of a home-based behavioral intervention (PRIME) for chronic pain and depression in older women with disabilities. No results are reported in this registry entry. The study enrolled only 9 participants and was terminated, precluding any meaningful inference about efficacy.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a terminated registry record with no reported results; only 9 participants were enrolled in an uncontrolled behavioral intervention pilot, making it a feasibility study without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05619510). This is a study registration, not published results. Lead sponsor: Johns Hopkins University. Recruitment status: TERMINATED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 9 participants (ACTUAL). Conditions: Pain, Chronic, Depressive Symptoms, Depression, Disability Physical. Interventions: BEHAVIORAL: PRIME Intervention. Primary outcome measures: Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure , Baseline and 12 weeks; Pain Interference as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) , Baseline and 12 weeks.; Pain Behavior as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain Behavior Measure , Baseline and 12 weeks.; Depression as Assessed by the Patient Health Questionnaire 9 (PHQ9) , Baseline and 12 weeks.; Depression as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57 , Baseline and 12 weeks. Brief summary: Chronic pain and depression or low mood are often experience by women who age with or into disabilities. Due to various factors women with disabilities often experience this cycle of pain and depression. Both of these conditions can be debilitating and lead to declines in health. Treating these conditions simultaneously, particularly , in older adults can be complicated due to side effects, risks of poor access to pain management and mental health care , and complications from other co occuring conditions. In order to address this cycle in older women with disabilities the investigators are testing the Women in Pain Reduction through Improved Mood and Empowerment (PRIME) study. The PRIME intervention includes four in person visits by a nurse to the women's homes where the participants set goals regarding pain and depression and the nurse helps the participants strategize ways to meet these goals. The second component of the study will be eight group sessions virtually with other participants in the study. The group sessions will be led by a clinical psychologist who will engage in Acceptance Commitment Therapy with the women.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.