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

Phase 2

Completed

• Conditions: Spinal Cord Injury; Chronic Pain
• Interventions: Behavioral: Positive Psychology intervention; Behavioral: Positive Psychology intervention (Control exercise)

• 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

Arm && Interventions

Group	Intervention	Description
T3P Intervention group	Positive Psychology intervention	Intervention group: Participants are instructed to practice 4 out of 10 different Positive Psychology Exercises (Gratitude, Optimism, Act of Kindness, Social Relations, Forgiveness, Flow, Savoring, Goals, Spirituality, Taking Care of the Body) for at least 15 minutes, at least one day every week including on "bad" days (defined as days with higher than average levels of pain intensity or feeling "down in the dumps") for 8 weeks.
Control group	Positive Psychology intervention (Control exercise)	Control group: Control Exercise (Attention Training): Participants assigned to the control group are instructed to be more attentive to their surroundings and write about three specific events or activities from the past 7 days for at least 15 minutes once a week for 8 weeks. This condition is designed to control for the effects of time and participation in an intervention activity.

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