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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3P Intervention group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychology intervention | Behavioral | 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Müller | Swiss Paraplegic Research, Nottwil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Research | Nottwil | Canton of Lucerne | 6207 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33264568 | Derived | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Positive Psychology intervention (Control exercise) | Behavioral | 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. |
|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |