Clinical trial NCT04010019: The Facing Pain Study
Official title: The Impact of Facebook Support Groups for Adults With Chronic Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
timeFrame: 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)
measure: Change in pain interference from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory
timeFrame: 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 outcomes:
measure: Change in depression from baseline to post-intervention to 1-month follow-up
timeFrame: 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)
measure: Change in anxiety from baseline to post-intervention to 1-month follow-up
timeFrame: 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)
measure: Change in perceived chronic pain social support from baseline to post-intervention to 1-month follow-up
timeFrame: 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)
measure: Change in anger from baseline to post-intervention to 1-month follow-up
timeFrame: 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)
measure: Change in self-efficacy for managing pain: PROMIS Self-Efficacy for Managing Symptoms v1.0
timeFrame: 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)
measure: Change in helplessness
timeFrame: 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)
measure: Change in self-efficacy for managing emotions: PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0
timeFrame: 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)
measure: Change in social isolation
timeFrame: 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)
measure: Change in pain catastrophizing: Pain Catastrophizing Scale
timeFrame: 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)
measure: Change in alexithymia
timeFrame: 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)
measure: Change in substance use
timeFrame: 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)
measure: Perceived emotional support within the Facebook group
timeFrame: Perceived emotional support within the Facebook group will be assessed at post-intervention (i.e., immediately after the intervention)
Other outcomes:
measure: Ambivalence over emotional expression
timeFrame: Ambivalence over emotional expression will be assessed at baseline (i.e., at the start of the intervention)
measure: Perceived social constraints
timeFrame: Perceived social constraints will be assessed at baseline (i.e., at the start of the intervention)
measure: Childhood adverse events
timeFrame: Childhood adverse events will be assessed at baseline (i.e., at the start of the intervention)
measure: Attachment style
timeFrame: Attachment style will be assessed at baseline (i.e., at the start of the intervention)
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: