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

NCT02459028 | Completed Phase 2

• 1 other identifier: 2014-24
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

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

  Pain Numeric Rating Scale (0-10)

  Baseline (Pre-treatment)

• Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment

  Pain Numeric Rating Scale (0-10)

  Mid-treatment (at 4 weeks)

• Change from baseline in Pain Numeric Rating Scale (pain intensity) at Post-treatment

  Pain Numeric Rating Scale (0-10)

  Post-treatment (at 8 weeks)

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

  Pain Numeric Rating Scale (0-10)

  Follow-up (at 20 weeks or at 3 months after post-treatment)

Study Arms (2)

T3P Intervention group

EXPERIMENTAL

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.

Behavioral: Positive Psychology intervention

Control group

ACTIVE COMPARATOR

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.

Behavioral: Positive Psychology intervention (Control exercise)

Interventions

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.

T3P Intervention group

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.

Control group

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (1)

• Muller R, Segerer W, Ronca E, Gemperli A, Stirnimann D, Scheel-Sailer A, Jensen MP. Inducing positive emotions to reduce chronic pain: a randomized controlled trial of positive psychology exercises. Disabil Rehabil. 2022 Jun;44(12):2691-2704. doi: 10.1080/09638288.2020.1850888. Epub 2020 Dec 2.

  PMID: 33264568 DERIVED

MeSH Terms

Conditions

Chronic Pain; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel Müller

  Swiss Paraplegic Research, Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: June 1, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

CH (1)