Clinical trial NCT02459028: Positive Psychology Interventions in Individuals With Chronic Pain and Spinal Cord Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Spinal Cord Injury
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2015-06-01
Enrollment: 168
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in Pain Numeric Rating Scale (pain intensity)
timeFrame: Baseline (Pre-treatment)
measure: Change from baseline in Pain Numeric Rating Scale (pain intensity) at Mid-treatment
timeFrame: Mid-treatment (at 4 weeks)
measure: Change from baseline in Pain Numeric Rating Scale (pain intensity) at Post-treatment
timeFrame: Post-treatment (at 8 weeks)
measure: Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up
timeFrame: Follow-up (at 20 weeks or at 3 months after post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Research
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Research, Nottwil
name: Rachel Müller
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.