The Facing Pain Study
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Facebook Condition
Control Facebook Condition
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Must have chronic pain (i.e., pain that persists for greater than 3 months)
- Must be fluent at reading and writing in English
- Must have an active Facebook account and check Facebook at least 3 times a week
Exclusion Criteria:
- Terminal illness such as cancer
- Active psychosis (e.g., hallucinations, delusions)
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced Facebook Condition
Control Facebook Condition
Arm Description
The enhanced Facebook group will be moderated by clinicians and offer psychosocial pain management techniques.
In the control condition, there will be no outside intervention; rather, the investigators will instruct participants to offer mutual support for the duration of the group and will not comment further.
Outcomes
Primary Outcome Measures
Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Brief Pain Inventory (Cleeland, 1991): Pain severity items: 1) Worst pain (0 [no pain] - 10 [pain as bad as you can imagine]), 2) Average pain (0 [no pain] - 10 [pain as bad as you can imagine]), 3) A composite of the 4 pain items (a mean pain severity score) will also be computed (0 [no pain] - 10 [pain as bad as you can imagine])
Change in pain interference from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Brief Pain Inventory (Cleeland, 1991): Pain interference items: A composite of the 7 interference items (a mean interference score) will be computed (0 [does not interfere] - 10 [completely interferes])
Secondary Outcome Measures
Change in depression from baseline to post-intervention to 1-month follow-up
PROMIS Emotional Distress - Depression - Short Form 8a v1.0: A composite of the 8 depression items (a mean depression score) will be computed (1 [low depression score] - 5 [high depression score])
Change in anxiety from baseline to post-intervention to 1-month follow-up
PROMIS Emotional Distress - Anxiety - Short Form 8a v1.0: A composite of the 8 anxiety items (a mean anxiety score) will be computed (1 [low anxiety score] - 5 [high anxiety score])
Change in perceived chronic pain social support from baseline to post-intervention to 1-month follow-up
Diabetes Support Scale (Barrera, 2002), adapted for chronic pain: A summed score of the 12 support items will be computed (12-84, higher scores indicate greater support)
Change in anger from baseline to post-intervention to 1-month follow-up
PROMIS Anger - Short Form 5a v1.1: A composite of the 5 anger items (a mean anger score) will be computed (1 [low anger score] - 5 [high anger score])
Change in self-efficacy for managing pain: PROMIS Self-Efficacy for Managing Symptoms v1.0
PROMIS Self-Efficacy for Managing Symptoms v1.0 (10 items from the larger 30-item measure, adapted for self-efficacy for managing pain): A composite of the 10 self-efficacy items (a mean self-efficacy score) will be computed (1 [low self-efficacy score] - 5 [high self-efficacy score])
Change in helplessness
Arthritis Helplessness Index (Nicassio et al., 1985), adapted for chronic pain: A summed score of the 15 helplessness items will be computed (15-60, higher scores indicate greater helplessness)
Change in self-efficacy for managing emotions: PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0
PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0: A composite of the 4 self-efficacy items (a mean self-efficacy score) will be computed (1 [low self-efficacy score] - 5 [high self-efficacy score])
Change in social isolation
PROMIS - Social Isolation - Short Form 8a v2.0: A composite of the 8 social isolation items (a mean social isolation score) will be computed (1 [low social isolation score] - 5 [high social isolation score])
Change in pain catastrophizing: Pain Catastrophizing Scale
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Change in alexithymia
Toronto Alexithymia Scale (TAS-20): A summed score of the 20 alexithymia items will be computed (20-100, higher scores indicate greater alexithymia)
Change in substance use
Substance use questionnaire: 4 question-set recommended by the NIAAA (adapted for the "past week"): 1) Frequency of drinking / opioid use / marijuana use (0 [never] - 5 [every day]), 2) Number of drinks (0 [no drinks] - 10 [25 or more drinks]), 3) Maximum drinks (0 [no drinks] - 10 [36 or more drinks], 4) Frequency of binge drinking (0 [never] - 5 [every day])
Perceived emotional support within the Facebook group
PROMIS - Emotional Support - Short Form 8a, adapted for in-group support: A composite of the 8 emotional support items (a mean emotional support score) will be computed (1 [low emotional support score] - 5 [high emotional support score])
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04010019
Brief Title
The Facing Pain Study
Official Title
The Impact of Facebook Support Groups for Adults With Chronic Pain: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized trial will create and compare two private Facebook conditions for patients with chronic pain. The control condition will be comprised of groups of patients who communicate without much clinician / moderator input, and the experimental condition will have a clinician moderating and teaching patients several techniques designed to facilitate social disclosure, validation, and emotional engagement with avoided activities.
Detailed Description
This study will investigate the effectiveness of a private Facebook group for individuals in chronic pain. Currently, more than 100,000 individuals with chronic pain (ICPs) participate in Facebook groups, seeking support from others in similar situations. There are currently some online self-management programs for ICPs; however, most lack a peer support aspect, as they are individualized, self-directed, and focus on instructing patients in how to manage their pain. The goals of the proposed online pain support group are: 1) to provide peer-to-peer social support for individuals with chronic pain; and 2) to disseminate psychosocial pain management techniques using a social media platform. Screened participants will be assigned to one of two conditions: a Facebook group similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group that is moderated by clinicians and offers psychosocial pain management techniques (experimental condition). Both conditions involve peer-to-peer healthcare and support, but the experimental group additionally includes components such as psychoeducation about pain neuroscience, emotional validation training, guided emotional disclosure, and activities to overcome emotional and behavioral avoidance. Findings from this study will offer important information about the impact of Facebook support groups on pain outcomes, and test whether psychosocial pain interventions can be disseminated using a social media platform.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interested adults will be screened, and eligible participants will be randomly assigned to one of two conditions: a Facebook group for individuals in pain similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group for individuals in pain that is moderated by clinicians and offers psychosocial pain intervention techniques (experimental condition).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Facebook Condition
Arm Type
Experimental
Arm Description
The enhanced Facebook group will be moderated by clinicians and offer psychosocial pain management techniques.
Arm Title
Control Facebook Condition
Arm Type
Active Comparator
Arm Description
In the control condition, there will be no outside intervention; rather, the investigators will instruct participants to offer mutual support for the duration of the group and will not comment further.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Facebook Condition
Intervention Description
The intervention (enhanced Facebook condition) will consist of several training components that were selected based on pain research and platform affordances. The first component will be psychoeducation on pain neurobiology. Emotional validation training will follow. The third component will consist of facilitating patients' emotional disclosure about their pain journeys and lives. The fourth and final intervention component will include prompts to engage participants in activities that they have been avoiding because of their pain.
Intervention Type
Behavioral
Intervention Name(s)
Control Facebook Condition
Intervention Description
The control condition will instruct participants to offer mutual support and will not offer psychosocial intervention.
Primary Outcome Measure Information:
Title
Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Description
Brief Pain Inventory (Cleeland, 1991): Pain severity items: 1) Worst pain (0 [no pain] - 10 [pain as bad as you can imagine]), 2) Average pain (0 [no pain] - 10 [pain as bad as you can imagine]), 3) A composite of the 4 pain items (a mean pain severity score) will also be computed (0 [no pain] - 10 [pain as bad as you can imagine])
Time Frame
Pain severity will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in pain interference from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
Description
Brief Pain Inventory (Cleeland, 1991): Pain interference items: A composite of the 7 interference items (a mean interference score) will be computed (0 [does not interfere] - 10 [completely interferes])
Time Frame
Pain interference will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Secondary Outcome Measure Information:
Title
Change in depression from baseline to post-intervention to 1-month follow-up
Description
PROMIS Emotional Distress - Depression - Short Form 8a v1.0: A composite of the 8 depression items (a mean depression score) will be computed (1 [low depression score] - 5 [high depression score])
Time Frame
Depression will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in anxiety from baseline to post-intervention to 1-month follow-up
Description
PROMIS Emotional Distress - Anxiety - Short Form 8a v1.0: A composite of the 8 anxiety items (a mean anxiety score) will be computed (1 [low anxiety score] - 5 [high anxiety score])
Time Frame
Anxiety will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in perceived chronic pain social support from baseline to post-intervention to 1-month follow-up
Description
Diabetes Support Scale (Barrera, 2002), adapted for chronic pain: A summed score of the 12 support items will be computed (12-84, higher scores indicate greater support)
Time Frame
Perceived chronic pain social support will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in anger from baseline to post-intervention to 1-month follow-up
Description
PROMIS Anger - Short Form 5a v1.1: A composite of the 5 anger items (a mean anger score) will be computed (1 [low anger score] - 5 [high anger score])
Time Frame
Anger will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in self-efficacy for managing pain: PROMIS Self-Efficacy for Managing Symptoms v1.0
Description
PROMIS Self-Efficacy for Managing Symptoms v1.0 (10 items from the larger 30-item measure, adapted for self-efficacy for managing pain): A composite of the 10 self-efficacy items (a mean self-efficacy score) will be computed (1 [low self-efficacy score] - 5 [high self-efficacy score])
Time Frame
Self-efficacy for managing pain will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in helplessness
Description
Arthritis Helplessness Index (Nicassio et al., 1985), adapted for chronic pain: A summed score of the 15 helplessness items will be computed (15-60, higher scores indicate greater helplessness)
Time Frame
Helplessness will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in self-efficacy for managing emotions: PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0
Description
PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0: A composite of the 4 self-efficacy items (a mean self-efficacy score) will be computed (1 [low self-efficacy score] - 5 [high self-efficacy score])
Time Frame
Self-efficacy for managing emotions will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in social isolation
Description
PROMIS - Social Isolation - Short Form 8a v2.0: A composite of the 8 social isolation items (a mean social isolation score) will be computed (1 [low social isolation score] - 5 [high social isolation score])
Time Frame
Social isolation will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in pain catastrophizing: Pain Catastrophizing Scale
Description
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Time Frame
Pain catastrophizing will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in alexithymia
Description
Toronto Alexithymia Scale (TAS-20): A summed score of the 20 alexithymia items will be computed (20-100, higher scores indicate greater alexithymia)
Time Frame
Alexithymia will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Change in substance use
Description
Substance use questionnaire: 4 question-set recommended by the NIAAA (adapted for the "past week"): 1) Frequency of drinking / opioid use / marijuana use (0 [never] - 5 [every day]), 2) Number of drinks (0 [no drinks] - 10 [25 or more drinks]), 3) Maximum drinks (0 [no drinks] - 10 [36 or more drinks], 4) Frequency of binge drinking (0 [never] - 5 [every day])
Time Frame
Substance use will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)
Title
Perceived emotional support within the Facebook group
Description
PROMIS - Emotional Support - Short Form 8a, adapted for in-group support: A composite of the 8 emotional support items (a mean emotional support score) will be computed (1 [low emotional support score] - 5 [high emotional support score])
Time Frame
Perceived emotional support within the Facebook group will be assessed at post-intervention (i.e., immediately after the intervention)
Other Pre-specified Outcome Measures:
Title
Ambivalence over emotional expression
Description
Ambivalence Over Emotional Expressiveness Questionnaire (King & Emmons, 1990): A composite of the 14 ambivalence items (a mean ambivalence score) will be computed (1 [low ambivalence score] - 5 [high ambivalence score])
Time Frame
Ambivalence over emotional expression will be assessed at baseline (i.e., at the start of the intervention)
Title
Perceived social constraints
Description
General Social Constraints Scale (Lepore & Ituarte, 1999): A summed score of the 15 social constraints items will be computed (15-60, higher scores indicate greater perceived social constraints)
Time Frame
Perceived social constraints will be assessed at baseline (i.e., at the start of the intervention)
Title
Childhood adverse events
Description
Adverse Childhood Experience (ACE) Questionnaire: A summed score of the 10 ACE items will be computed (0-10, higher scores indicate greater adverse childhood experiences)
Time Frame
Childhood adverse events will be assessed at baseline (i.e., at the start of the intervention)
Title
Attachment style
Description
Experiences in Close Relationships Scale - Revised (ECR_R), avoidance items only (18 items): A composite of the 18 avoidance items (a mean avoidance score) will be computed (1 [low avoidance score] - 7 [high avoidance score])
Time Frame
Attachment style will be assessed at baseline (i.e., at the start of the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have chronic pain (i.e., pain that persists for greater than 3 months)
Must be fluent at reading and writing in English
Must have an active Facebook account and check Facebook at least 3 times a week
Exclusion Criteria:
Terminal illness such as cancer
Active psychosis (e.g., hallucinations, delusions)
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Facing Pain Study
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