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

Chronic Pain Clinical Trial

— T3P  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459028
• Other study ID #: 2014-24
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2023
• Source: Swiss Paraplegic Research, Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Behavioral:
• Positive Psychology intervention
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)
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.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Research	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Pain Numeric Rating Scale (pain intensity)	Pain Numeric Rating Scale (0-10)	Baseline (Pre-treatment)
Primary	Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment	Pain Numeric Rating Scale (0-10)	Mid-treatment (at 4 weeks)
Primary	Change from baseline in Pain Numeric Rating Scale (pain intensity) at Post-treatment	Pain Numeric Rating Scale (0-10)	Post-treatment (at 8 weeks)
Primary	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)