Online "Pain, Stress & Emotions" Class in Chronic Pain
12 maj 2022 uppdaterad av: Maisa Ziadni, Stanford University
Online "Pain, Stress & Emotions" Class in Chronic Pain: Single-arm Efficacy Test
Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, & Emotions".
Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks after class attendance.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
120
Fas
- Tidig fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
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Palo Alto, California, Förenta staterna, 94304
- Rekrytering
- Stanford University
-
Kontakt:
- Maisa Ziadni, PhD
- Telefonnummer: 650-736-5494
- E-post: mziadni@stanford.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Chronic pain condition (pain > 3 months)
- Access to the internet
- English fluency
Exclusion Criteria:
- Ongoing legal action or disability claim
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Pain, Stress, & Emotions Class
No active or placebo comparator will be used.
This is a single-arm study design.
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2-hour, zoom-delivered, group intervention focused on teaching patients how pain is processed in their brain and learning about the role of psychosocial factors in their pain conditions.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity NRS
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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Self-reported pain intensity rating
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported pain interference levels
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: Depression 6a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported depression
|
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: Anxiety 6a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported anxiety
|
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: Physical Function 8b
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported physical functioning
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported sleep disturbance
|
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: social isolation 6a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported social isolation
|
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: fatigue 6a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported fatigue
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
|
Patient-Reported Outcomes Measurement Information System: anger 5a
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported anger
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
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Ambivalence over Emotional Expression (AEQ)
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
self-reported ambivalence levels about emotional expression
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
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Emotion-Approach Coping
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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8-item emotion approach coping scale
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
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Pain Bothersomeness
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
single-item assessing self-reported levels of pain bothersomeness
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain Attributions Questionnaires
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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Two self-report questionnaires were developed to assess psychological and brain influences on pain.
The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based.
Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale
Tidsram: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
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Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Holmes HJ, Thakur ER, Carty JN, Ziadni MS, Doherty HK, Lockhart NA, Schubiner H, Lumley MA. Ambivalence over emotional expression and perceived social constraints as moderators of relaxation training and emotional awareness and expression training for irritable bowel syndrome. Gen Hosp Psychiatry. 2018 Jul-Aug;53:38-43. doi: 10.1016/j.genhosppsych.2018.05.002. Epub 2018 May 3.
- Carty JN, Ziadni MS, Holmes HJ, Tomakowsky J, Peters K, Schubiner H, Lumley MA. The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial. Pain Med. 2019 Jul 1;20(7):1321-1329. doi: 10.1093/pm/pny182.
- Ziadni MS, Carty JN, Doherty HK, Porcerelli JH, Rapport LJ, Schubiner H, Lumley MA. A life-stress, emotional awareness, and expression interview for primary care patients with medically unexplained symptoms: A randomized controlled trial. Health Psychol. 2018 Mar;37(3):282-290. doi: 10.1037/hea0000566. Epub 2017 Nov 20.
- Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 augusti 2021
Primärt slutförande (Förväntat)
20 september 2023
Avslutad studie (Förväntat)
20 december 2023
Studieregistreringsdatum
Först inskickad
12 augusti 2021
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2021
Första postat (Faktisk)
20 augusti 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- StanfordClass
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Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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