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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Swiss Paraplegic Research, Nottwil
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment
Time Frame: Mid-treatment (at 4 weeks)
Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up
Time Frame: 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)
Time Frame: Baseline (Pre-treatment)
Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Post-treatment
Time Frame: Post-treatment (at 8 weeks)
Pain Numeric Rating Scale (0-10)