Comparative Mechanisms of Psychosocial Chronic Pain Treatments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

521 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-07-31

Brief Summary

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Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.

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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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cognitive therapy

Cognitive therapy will be delivered to decrease pain interference

Group Type ACTIVE_COMPARATOR

cognitive therapy

Intervention Type BEHAVIORAL

treatment as usual

Intervention Type OTHER

mindfulness training

Mindfulness training will be delivered to decrease pain interference

Group Type ACTIVE_COMPARATOR

mindfulness training

Intervention Type BEHAVIORAL

treatment as usual

Intervention Type OTHER

behavior therapy

Behavior therapy will be delivered to decrease pain interference

Group Type ACTIVE_COMPARATOR

behavioral therapy

Intervention Type BEHAVIORAL

treatment as usual

Intervention Type OTHER

treatment as usual

Subjects will engage in their usual care for low back pain.

Group Type ACTIVE_COMPARATOR

treatment as usual

Intervention Type OTHER

Interventions

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cognitive therapy

Intervention Type BEHAVIORAL

mindfulness training

Intervention Type BEHAVIORAL

behavioral therapy

Intervention Type BEHAVIORAL

treatment as usual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months
* musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory)
* age between 18 and 75 years.

Exclusion Criteria

* meet criteria for alcohol or substance abuse problems
* meet criteria for past or present psychotic or bipolar disorders
* inability to understand English well enough to complete questionnaires or to participate in therapy
* active suicidal ideation with intent
* pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No