Johns Hopkins School of Nursing
Baltimore, Maryland, 21213, United States
NCT Number: NCT05619510
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.
Looking for future studies?
Notify Me50 year and older
Female
Interventional
Not applicable
Baltimore, Maryland, 21213, United States
Chronic pain and depression frequently co-occur among older women with disabilities, and each can exacerbate the other in a worsening cycle. This co-occurrence may be due, in part, to pain and depression sharing biologic etiologies such as inflammation. Beyond each individual category of risk, the intersection of age, sex, and disability place older women with disabilities at even higher risk of having co-occurring pain and depression.There are several effective multi-component behavioral interventions for either pain or depression, but not both outcomes in combination, and none were designed to integrate social determinants of health to address the inequities inherent in being an older woman with disabilities. Addressing these two conditions in this population warrants multicomponent interventions that are appropriate for and inclusive of all older women with disabilities. The proposed study is to apply self-regulation theory to refine and further test the feasibility of a tailored behavioral activation intervention, older women with disabilities in Pain Reduction through Improved Mood and Empowerment (PRIME) Study Aim 1: Leveraging the investigators previous research, the investigators will enroll 15-30 community dwelling women , ages 50 and over, with physical disabilities , living in Maryland who have pain and depression in the Women in PRIME clinical trial.
Aim 2: The investigators will determine a) feasibility and acceptability of the intervention and b) if strategies and evaluation techniques are appropriate.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants who are randomized to the intervention will participate in five virtual or in person visits with a nurse where the nurse uses self regulation theory as a guide to help them set their own goals surrounding pain and depression and use tailored strategies to address these goals. The second component will include six virtual Acceptance Commitment Therapy (ACT) sessions, led by a clinical psychologist. There will be 3-5 other research participants in the sessions.
Time frame: Baseline, 12 weeks, 24 weeks
Pain Intensity will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure. PROMIS Pain Intensity is a 3 question measure with a range of 3-15 with a higher score indicating increased pain intensity.
Time frame: Baseline, 12 weeks, 24 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 6-30 with a higher score indicating increased pain interference.
Time frame: Baseline, 12 weeks, 24 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 20 question measure with a range of 20-100 with a higher score indicating increased pain behaviors
Time frame: Baseline, 12 weeks, 24 weeks
The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms. The score range is 0-27 with a higher score indicating more severe depression.
Time frame: Baseline, 12 weeks, 24 weeks
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
Time frame: Baseline, 12 weeks, 24 weeks
The Psychological Flexibility in Pain Instrument will be used. The ability to act in alignment of goals, values and in acceptance while living with pain and distress.The Psychological Inflexibility in Pain Scale (PIPS) is a 12-item scale measuring avoidance of pain, and fusion with pain thoughts. Scores range from 7-84 with a higher score indicating increased psychological inflexibility in pain.
Time frame: Baseline and 12 weeks
All three IL-6, IL-8, tumor necrosis factor (TNF) and will be on a cytokine panel that will be measured using sweat patches. The unit of measurement used will be picograms per millimeter (pg/ml) .
Time frame: At baseline and at 12 weeks
Self-report if goals were achieved fully, partially or not at all
Time frame: Baseline and 12 weeks
The Charlson Comorbidity Index will be used to obtain a score for number of chronic conditions from 19 categories.The CCI consists of 19 selected conditions that are weighted and summed to an index on a 0-33 scale. Higher scores indicate more comorbidities.
Time frame: Baseline and 12 weeks
Sleep disturbance will be measured using the 4 item PROMIS sleep disturbance measure. This six item scale is used to measure sleep disturbances in the past 7 days and the range is 6 -30 with higher scores indicating more sleep disturbances.
Time frame: Baseline and 12 weeks
The Patients' Reaction Assessment has a 5-item subscale used to measure perceived ability to communicate with providers. The sub scale on perceived ability to communicate with providers can have scores ranging from 0-35 with higher scores indicating higher perceived ability to communicate.
Johns Hopkins University
Other
Testing an Intervention to Reduce Pain and Depression Among Older Women With Physical Disabilities
Acronym: PRIME
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.
Published trials that share one or more normalized conditions with this study.
NCT05122676
Anxiety, Anxiety Disorders
Indianapolis, Indiana, United States
View Trial DetailsNCT02463266
Anxiety, Anxiety Disorders
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT03649958
Anxiety Disorders, Behavior
Bethesda, Maryland, United States
View Trial DetailsNCT03221127
Arterial Occlusive Diseases, Arteriosclerosis
View Trial Details