The Facing Pain Study

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010019
• Other study ID #: 012119B3E
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: April 13, 2020

Study information

• Verified date: April 2020
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Enhanced Facebook Condition
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.
• Control Facebook Condition
The control condition will instruct participants to offer mutual support and will not offer psychosocial intervention.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ambivalence over emotional expression	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])	Ambivalence over emotional expression will be assessed at baseline (i.e., at the start of the intervention)
Other	Perceived social constraints	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)	Perceived social constraints will be assessed at baseline (i.e., at the start of the intervention)
Other	Childhood adverse events	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)	Childhood adverse events will be assessed at baseline (i.e., at the start of the intervention)
Other	Attachment style	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])	Attachment style will be assessed at baseline (i.e., at the start of the intervention)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)