- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03256617
The Development of a Cognitive Reassurance Training Program
The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Identifying strategies to favorably alter unhelpful cognitions of patients with recent onset low back pain is a research priority and could help curb the transition from acute to chronic low back pain; lessening the need for prolonged and costly management. Current evidence suggests that psychological factors, including maladaptive pain beliefs and avoidant behaviors and expectations for recovery, are associated with poor outcomes in patients with low back pain. Recently, considerable attention has been given to training non-psychologists to provide psychologically based interventions for patients with low back pian. A recent review of interventions that included psychological approaches noted that all of the trials that failed to show benefit included delivery of the intervention by non-psychologists. Authors suggest that increasing the effort in selecting, training, supervising and assessing the competence of the practitioners delivering the treatment could improve results.
Low back pain comprises approximately 50% of the caseload of outpatient physical therapists physical therapists making physical therapists ideally positioned to manage the unhelpful cognitions of patients with low back pain. However, physical therapists often feel unprepared when managing the cognitive factors associated with low back pain. The purpose of this project is to develop and assess the effectiveness of a training program for physical therapists that focuses on cognitive reassurance; a novel cognitive intervention for patients with low back pain.
Cognitive reassurance is a communication approach in which maladaptive beliefs and expectations are identified. Tailored explanations for the patient's conditions are then provided, possible prognosis and treatment are discussed, and clarifications are offered. With adequate training, physical therapists could utilize cognitive reassurance to promote patients' understanding of his/her condition and modify maladaptive low back pain-related beliefs and expectations.
The proposed pilot study will use a pre-post design to examine the impact of cognitive reassurance training on the low back pain beliefs and skills in physical therapists and physical therapist assistants. Following the training the investigators will recruit patients who have scheduled an evaluation for low back pain with the physical therapists who attended the training. Patient data will be collected at baseline before the evaluation and follow up data at 2, 4 and 8 weeks.
The specific aims are: 1) Evaluate the feasibility of a cognitive reassurance training program for physical therapists that focuses on modifying physical therapists' beliefs and improving physical therapists' skill in the application of cognitive reassurance for patients with acute/subacute low back pain. 2) Evaluate the application of cognitive reassurance by physical therapists to patients with acute/sub-acute low back pain. 3) Examine the association between physical therapist application of cognitive reassurance and short-term changes in the patient's low back pain beliefs and expectations (low back pain beliefs, self-efficacy, pain catastrophizing, fear-avoidance).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
Utah
-
Salt Lake City, Utah, Vereinigte Staaten, 84132
- University of Utah Health Care Out Patient Physical Therapy Clinics
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Therapist inclusion criteria:
- University of Utah Health Care physical therapists and physical therapist assistants
- Employed at least 20 hours a week
- Licensed in the state of Utah
Therapist exclusion criteria:
- None
Patient inclusion criteria
- Primary reason for scheduling an evaluation with a physical therapist is low back pain (defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without referral in to one or both legs
- Current episode of low back pain ≤ 12 weeks duration
- Age 18-64
- Ability to read and speak English
Patient exclusion criteria
- Report being referred to physical therapy for specific low back pathology (e.g. fracture)
- Any lumbar surgery in the past 6 months
- Current pregnancy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Provider training
|
The 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities.
The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain.
The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain.
The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in back beliefs questionnaire for health care providers
Zeitfenster: Baseline, 5 days
|
Measures providers' beliefs about back pain pre and post training
|
Baseline, 5 days
|
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Low back pain vignettes
Zeitfenster: End of 2nd day of therapist training
|
Measures provider decision making related to cognitive reassurance
|
End of 2nd day of therapist training
|
|
Skills assessment
Zeitfenster: End of 2nd day of therapist training
|
Assess skills in the provision of cognitive reassurance during role-playing activity
|
End of 2nd day of therapist training
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the Pain Catastrophizing Scale
Zeitfenster: Baseline, 4 weeks and 8 weeks
|
Measure of patient's pain catastrophizing
|
Baseline, 4 weeks and 8 weeks
|
|
Change in fear the Avoidance Beliefs Questionnaire
Zeitfenster: Baseline, 4 weeks and 8 weeks
|
Measure of patient's fear-avoidance beliefs.
|
Baseline, 4 weeks and 8 weeks
|
|
Change in the Pain Self-efficacy Questionnaire
Zeitfenster: Baseline, 4 weeks and 8 weeks
|
Measure of patient's pain self-efficacy
|
Baseline, 4 weeks and 8 weeks
|
|
Change in the Back Beliefs Questionnaire
Zeitfenster: Baseline, 4 weeks and 8 weeks
|
Measure of patient's back beliefs
|
Baseline, 4 weeks and 8 weeks
|
|
Patient check list
Zeitfenster: 2 weeks following initial evaluation for low back pain by a physical therapist
|
Measure whether key messages of cognitive reassurance were perceived by the patient.
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2 weeks following initial evaluation for low back pain by a physical therapist
|
|
Open-ended question
Zeitfenster: 2 weeks following the initial evaluation for low back pain by a physical therapist
|
Asks the patient to list the most important things they learned learned in physical therapy
|
2 weeks following the initial evaluation for low back pain by a physical therapist
|
|
Provider check list
Zeitfenster: 2 weeks status post initial evaluation of patient with low back pain
|
Measures whether key cognitive reassurance messages were provided to the patient by the provider
|
2 weeks status post initial evaluation of patient with low back pain
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jake S Magel, PT, PhD, University of Utah
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 00100188
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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