The Facing Pain Study

Study Overview
=================
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.

Official Title
-----------------
The Impact of Facebook Support Groups for Adults With Chronic Pain: A Randomized Clinical Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Enhanced Facebook Condition
* Behavioral: Control Facebook Condition


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Facebook Condition<br>The enhanced Facebook group will be moderated by clinicians and offer psychosocial pain management techniques. | Behavioral: Enhanced Facebook Condition<br>* 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.<br>|
| Active Comparator: Control Facebook Condition<br>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. | Behavioral: Control Facebook Condition<br>* The control condition will instruct participants to offer mutual support and will not offer psychosocial intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]) | 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) | 
| 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]) | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]) | 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) | 
| 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]) | 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) | 
| 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) | 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) | 
| 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]) | 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) | 
| 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]) | 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) | 
| 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) | 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) | 
| 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]) | 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) | 
| 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]) | 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) | 
| 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) | 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) | 
| 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) | 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) | 
| 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]) | 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) | 
| 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]) | Perceived emotional support within the Facebook group will be assessed at post-intervention (i.e., immediately after the intervention) |