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Positive Psychology Interventions in Individuals With Chronic Pain and Spinal Cord Injury

Information source: Swiss Paraplegic Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain; Spinal Cord Injury

Intervention: Positive Psychology intervention (Behavioral); Positive Psychology intervention (Control exercise) (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: Swiss Paraplegic Research

Official(s) and/or principal investigator(s):
Rachel Müller, Principal Investigator, Affiliation: Swiss Paraplegic Research

Overall contact:
Rachel Müller, Dr., Phone: +41 41 939 65 59, Email: rachel.mueller@paraplegie.ch

Summary

Background: Chronic pain is one of the most burdensome potential consequences of a physical disability, such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range

between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology

intervention showed a significant reduction in pain intensity, pain interference, pain catastrophizing and depression and an enhancement of subjective well-being and control over pain in persons with chronic pain secondary to a physical disability. Study Objective: Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P) in a community-based, single-blind, randomized, controlled, parallel group trial on subjective well-being and pain in individuals with chronic pain secondary to SCI. Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in subjective well-being, and perceived control over pain and (2) greater immediate and long-lasting decrease in depression, pain intensity, pain interference and catastrophizing, relative to an active control treatment. Specific aim 1: To increase the understanding of the mechanisms underlying T3P by determining potential mediation effects. Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain intensity, and (2) positive and negative affect mediate the effect of T3P on life satisfaction and depression. Objective 2: To identify for whom T3P is most effective by exploring potential moderator effects. Study Design: The proposed study is a single-blind, randomized, controlled trial with a parallel group design to determine the effects and mechanisms of T3P in a Swiss community sample of persons with chronic pain secondary to SCI.

Clinical Details

Official title: A Phase II, Community-based, Single-blinded, Randomized Controlled, Parallel-group Trial to Assess the Effects of a Tailored Positive Psychology Intervention on Chronic Pain and Well-being in Individuals With Spinal Cord Injury

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Change from baseline in Pain Numeric Rating Scale (pain intensity)

Change from baseline in Pain Numeric Rating Scale (pain intensity) at Midtreatment

Change from baseline in Pain Numeric Rating Scale (pain intensity) at Posttreatment

Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Registered in Swiss Spinal Cord Injury Cohort Study (SwiSCI)

- Individuals who experience an average disability-related pain intensity of ≥ 4 on a

0-10 numeric rating scale in the past week

- Individuals who experience pain at least half the days in the past four weeks, and

- Individuals are able to speak, read and write German

Exclusion Criteria:

- Individuals who report current participation in any psychotherapy (e. g.

psychotherapy, hypnosis, biofeedback) once a month or more often

- Individuals who report hospitalization for psychiatric reasons within the past year

- Individuals with a severe cognitive impairment defined as one or more errors on a

Six-Item Screening

Locations and Contacts

Rachel Müller, Dr., Phone: +41 41 939 65 59, Email: rachel.mueller@paraplegie.ch

Swiss Paraplegic Research, Nottwil, Lucerne 6207, Switzerland; Recruiting
Rachel Müller, PhD, Phone: +41 41 939 65 59, Email: rachel.mueller@paraplegie.ch
Additional Information

Starting date: May 2015
Last updated: June 9, 2015

Page last updated: August 23, 2015

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