Terminé

Integrated Treatment for Chronic Pain and PTSD

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Ce qui est testé

Cognitive Behavioral Therapy - Pain

+ Cognitive Behavioral Therapy-Integrated

+ Cognitive Processing Therapy - PTSD

Comportemental
Qui peut participer

Troubles liés aux traumatismes et aux facteurs de stress+4

+ Troubles Mentaux

+ Manifestations Neurologiques

Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : septembre 2004
Voir le détail du protocole

Résumé

Sponsor principalUS Department of Veterans Affairs
Dernière mise à jour : 14 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Date de début de l'étude : 1 septembre 2004

Date à laquelle le premier participant a commencé l'étude.

Chronic pain and post-traumatic stress disorder frequently co-occur and are associated with a significant level of affective distress, physical disability, and treatment resistance. However, no empirical studies have been conducted investigating the efficacy of a treatment tailored specifically for individuals with comorbid chronic pain and PTSD. The primary objective of this study is to evaluate the efficacy of a cognitive-behavioral therapy approach for comorbid chronic pain and PTSD. A secondary objective of this study is to examine potential mechanisms of action that might mediate treatment outcome. It is hypothesized that: 1.a) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report significantly greater improvements on measures of pain, affective distress, and physical functioning from pre-treatment to post-treatment than participants in the Cognitive Behavioral Treatment for chronic pain, Cognitive Processing Therapy (CPT) for PTSD, or Treatment as Usual (TAU) conditions 1.b) All active treatments will be more effective at promoting improved outcomes than Treatment as Usual 2) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report decreased symptoms of PTSD from pre-treatment to post-treatment when compared to participants in the other conditions. 3) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report greater maintenance of change, and greater improvements on measures of Pain, Affective Distress, Physical Functioning, and PTSD at 6 months following the completion of treatment than participants in the other three conditions 4) As a secondary/exploratory hypothesis, the researchers will examine potential mechanisms of action in treatment. It is hypothesized that changes in these potential mechanisms will mediate treatment outcome. The proposed study is a four-treatment condition by three-evaluation period (pre-treatment, post-treatment, and 6-month follow-up) repeated measures factorial design with multiple dependent measures. Participants will be 136 patients with co-morbid chronic pain and PTSD receiving care in the VA Boston Healthcare System. Participants in the active treatment conditions will complete 11 weekly outpatient therapy sessions. A clinical psychologist with specialized training in providing both PTSD and chronic pain treatment protocols will conduct therapy in an individual format, 90 minutes in duration. Participants assigned to the TAU condition will not receive treatment beyond that provided by their primary care provider and other healthcare providers. The Cognitive Behavioral Therapy-PAIN condition will follow an adaptation of a manualized treatment protocol used by Kerns and colleagues that emphasizes identifying and modifying maladaptive thoughts and behaviors related to the experience of chronic pain. Participants in the Cognitive Processing Therapy - PTSD condition will receive a manualized treatment protocol that includes several empirically supported techniques including cognitive restructuring, exposure therapy, and skills training. Participants in the Cognitive Behavioral Therapy - Integrated condition will receive an integrated treatment for comorbid pain and PTSD including components of the pain and PTSD treatments described above. The proposed study will address the specific objectives of the National Pain Management Strategy by helping to assure that clinicians practicing in the VA healthcare system are adequately prepared to assess and manage chronic pain effectively, especially when comorbid with PTSD. Knowledge gained from the proposed study could potentially be utilized by psychologists and other healthcare providers across the VA system nationwide who are currently engaged in Cognitive Behavioral Therapy treatment programs for chronic pain and PTSD. Given that Cognitive Behavioral Therapy has been shown to be efficacious for pain and PTSD, but not for comorbid pain and PTSD, it is imperative that a new integrated treatment be evaluated that has the potential to address the unmet needs of this large population. Thus, this study will have important implications for the delivery of pain management services to veterans and others with chronic pain and PTSD.

Titre officielIntegrated Treatment for Chronic Pain and PTSD 
Sponsor principalUS Department of Veterans Affairs
Dernière mise à jour : 14 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

42 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles liés aux traumatismes et aux facteurs de stressTroubles MentauxManifestations NeurologiquesDouleurTroubles de stress post-traumatiqueTroubles liés au stress traumatiqueDouleur Chronique

Critères

Inclusion Criteria: * Patients will be eligible for participation if they have chronic pain, defined as constant pain of at least six months duration with a neurologic or musculoskeletal etiology. Patients must also meet criteria for PTSD. * Stability of pain and anxiety medications will be required for two months prior to study entry and during the active treatment and TAU phase. Exclusion Criteria: * Patients with life threatening or acute physical illness (e.g., cancer). * Current alcohol or substance abuse or dependence. Veterans who have a history of alcohol or drug dependence but who have not had problematic use in the last six months will be included in the study. * Current psychosis or suicidal ideation. * Individuals seeking pain treatment such as surgical interventions will be excluded.

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

4 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Cognitive Behavioral Therapy targeting chronic pain

Groupe II

Expérimental
Integrated treatment for comorbid chronic pain and PTSD

Groupe III

Expérimental
Cognitive Processing Therapy for PTSD

Groupe IV

Participants received care for pain and PTSD as usual from their Primary care provider

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

VA Boston Health Care System, Jamaica Plain

Boston, United StatesVoir le site
Terminé1 Centres d'Étude