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

Phase 2

Completed

• Conditions: Spinal Cord Injury; Chronic Pain

• Registration Number: NCT02459028
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-06-01
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment	Mid-treatment (at 4 weeks)	Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up	Follow-up (at 20 weeks or at 3 months after post-treatment)	Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity)	Baseline (Pre-treatment)	Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Post-treatment	Post-treatment (at 8 weeks)	Pain Numeric Rating Scale (0-10)

Trial Locations

Locations (1)

Swiss Paraplegic Research; 🇨🇭 Nottwil, Lucerne, Switzerland