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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Paraplegic Research, Nottwil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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