- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01769729
Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial (PEPP - RCT)
The overall aim of this program of research is to develop a collaborative psychotherapy for major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid chronic low back pain (CLBP).
The purpose of the proposed project is to establish the feasibility and acceptability of a research design for an eventual large-scale randomized clinical trial which would test the efficacy of PEPP in comparison to a control condition (depression care management).
To achieve the investigators specific aims, the investigators will conduct a pilot randomized clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in care management) or care management.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The overall aim of this program of research is to develop a collaborative psychotherapy for major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid chronic low back pain (CLBP). The newly developed intervention will integrate and build on behavior therapy for MDD and behavior therapy for chronic pain towards a key target of reducing behavioral avoidance. This 4-month collaborative psychotherapy, entitled Program for Emotional and Physical Pain (PEPP), will include 1 joint meeting with the behavioral health specialist (BHS), primary care provider (PCP), and patient, 10 psychotherapy sessions, and continued collaboration between the BHS and the PCP to assure a shared treatment plan.
The purpose of the proposed project is to establish the feasibility and acceptability of a research design for an eventual large-scale randomized clinical trial which would test the efficacy of PEPP in comparison to a control condition (depression care management)..
To achieve the investigators specific aims, the investigators will conduct a pilot randomized clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in care management) or care management. The specific aims are:
To develop and refine PEPP so that it meets standards of feasibility and acceptability for primary care physicians (PCPs), behavioral health specialists (BHSs), and participants;
- To develop, field-test, and finalize a PEPP manual;
- To develop a reliable measure of BHS adherence to the manual;
- To develop, field-test, and finalize BHS training and supervision procedures;
- To field-test and finalize procedures for depression care management;
- To establish that the investigators can adequately provide depression care management and that it is acceptable in this population;
- To develop and refine recruitment methods for an RCT and document an adequate rate of recruitment;
- To refine research procedures, e.g., consent process, randomization process, and assessment procedures, and establish their feasibility and acceptability to participants.
Ultimately, the investigators expect that this treatment development work will prepare us to apply for an R01 to conduct a large-scale, adequately powered RCT with the same research design as the pilot RCT proposed in this application. Depression will be the primary outcome variable assessed in the large-scale RCT; pain will be a secondary outcome variable. In the end, the investigators believe this line of work will lead to the incorporation into primary care of theoretically-driven and effective mental health treatment for patients with MDD and comorbid CLBP. To the best of the investigators knowledge, this would be the first empirically-tested psychotherapy protocol that specifically integrates treatment of major depression with CLBP.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Rhode Island
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Pawtucket, Rhode Island, Stati Uniti, 02860
- Family Care Center of Memorial Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Meets DSM-IV criteria for current major depressive disorder.
- Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score >11.
- Chronic low back pain. Pain must be > 6 months duration, in the low back (lumbar region), present > ½ the days of the month, and, on average, be of at least a moderate level of severity in the last month (> 4 on an 11-point numerical rating of pain intensity ranging from 0 [no pain] to10 [worst pain imaginable]. Pain-related disability / functional impact of pain must be of at least moderate severity at the time of intake, determined by a score of at > 7 on the Roland Morris Disability Questionnaire (RMDQ; (Roland & Morris, 1983))
- Continued pain despite having attempted initial steps of PCP guideline-based care (Chou et al., 2007). Participants must have been under the care of a physician for low back pain for > 6 months and have already had > 2 trials of recommended medications (i.e., acetaminophen, NSAIDs, skeletal muscle relaxants, opioids, and/or benzodiazepines).This will be judged through chart review and interviews with patients & PCPs.
- Antidepressant dose stable for previous 2 months. If the participant is taking an antidepressant, he/ she must have been on the same dose for the previous 2 months.
- Aged 18 or older.
- Have a PCP at one of our enrollment sites.
Exclusion Criteria:
- Lifetime diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition.
- Current hazardous illicit drug or alcohol use assessed with the AUDIT and DUDIT.
- Opiate misuse will be assessed with the COMM and via primary care chart review.
- Suicidal ideation or behavior requiring immediate attention.
- In psychotherapy or in a multidisciplinary pain management program at baseline.
- Anticipate having surgery in the next 6 months.
- Pain thought to be due to visceral disease, cancer, infection, or inflammatory arthritis or pain associated with severe or progressive neurological deficits.
- Current pregnancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: PEPP + care management
This 4-month collaborative psychotherapy, entitled Program for Emotional and Physical Pain (PEPP), will include 1 joint meetings with the behavioral health specialist (BHS), primary care provider (PCP), and patient, 10 psychotherapy sessions, and continued collaboration between the BHS and the PCP to assure a shared treatment plan. Care management will include monthly calls with a depression care manager. |
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Comparatore attivo: Care management alone
Care management will include monthly calls with a depression care manager.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Quick Inventory of Depression Symptoms
Lasso di tempo: 4 months
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assessment of depression
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4 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Lisa Uebelacker, PhD, Butler Hospital, Brown University
- Investigatore principale: Risa Weisberg, PhD, Brown University
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MH085762
- R34MH085762 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su PEPP
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University of Michigan Rogel Cancer CenterThe Breast Cancer Research FoundationCompletatoCancro al seno | Cancro ginecologicoStati Uniti