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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Pain, Spinal Cord Injury

Intervention / Treatment
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* Behavioral: Positive Psychology intervention
* Behavioral: Positive Psychology intervention (Control exercise)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T3P Intervention group<br>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<br>* 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.<br>|
| Active Comparator: Control group<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |