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

Primary Purpose

Chronic Pain, Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Positive Psychology intervention
Positive Psychology intervention (Control exercise)
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swiss Paraplegic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T3P Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Pain Numeric Rating Scale (pain intensity)
Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Midtreatment
Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Posttreatment
Pain Numeric Rating Scale (0-10)
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up
Pain Numeric Rating Scale (0-10)

Secondary Outcome Measures

Full Information

First Posted
February 16, 2015
Last Updated
April 13, 2016
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT02459028
Brief Title
Positive Psychology Interventions in Individuals With Chronic Pain and Spinal Cord Injury
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T3P Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychology intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychology intervention (Control exercise)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Pain Numeric Rating Scale (pain intensity)
Description
Pain Numeric Rating Scale (0-10)
Time Frame
Baseline (Pre-treatment)
Title
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Midtreatment
Description
Pain Numeric Rating Scale (0-10)
Time Frame
Midtreatment (at 4 weeks)
Title
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Posttreatment
Description
Pain Numeric Rating Scale (0-10)
Time Frame
Posttreatment (at 8 weeks)
Title
Change from baseline in Pain Numeric Rating Scale (pain intensity) at Follow-up
Description
Pain Numeric Rating Scale (0-10)
Time Frame
Follow-up (at 20 weeks or at 3 months after post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Müller
Organizational Affiliation
Swiss Paraplegic Research, Nottwil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Research
City
Nottwil
State/Province
Lucerne
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33264568
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.
Results Reference
derived

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

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