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Completed

NCT Number: NCT02459028

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

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.

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Key information

Conditions

Chronic Pain Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Psychology intervention

Behavioral

Intervention group: Participants are instructed to practice 4 out of 10 differentPositive 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.

Positive Psychology intervention (Control exercise)

Behavioral

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 outcomes

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

    Time frame: Baseline (Pre-treatment)

    Pain Numeric Rating Scale (0-10)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study 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

Acronym: T3P

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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