Positive Psychology Interventions in Individuals With Chronic Pain and Spinal Cord Injury (T3P)

November 6, 2023 updated by: Swiss Paraplegic Research, Nottwil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Lucerne
      • Nottwil, Lucerne, Switzerland, 6207
        • Swiss Paraplegic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T3P Intervention group
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
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.
Active Comparator: Control group
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Pain Numeric Rating Scale (pain intensity)
Time Frame: Baseline (Pre-treatment)
Pain Numeric Rating Scale (0-10)
Baseline (Pre-treatment)
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)
Follow-up (at 20 weeks or at 3 months after post-treatment)
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)
Mid-treatment (at 4 weeks)
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)
Post-treatment (at 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Research, Nottwil

Investigators

  • Principal Investigator: Rachel Müller, Swiss Paraplegic Research, Nottwil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimated)

June 1, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Positive Psychology intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe