The Facing Pain Study

NCT04010019 | Completed

• 1 other identifier: 012119B3E
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change in depression from baseline to post-intervention to 1-month follow-up

  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

  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

  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

  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

  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)

Other Outcomes (4)

• Ambivalence over emotional expression

  Ambivalence over emotional expression will be assessed at baseline (i.e., at the start of the intervention)

• Perceived social constraints

  Perceived social constraints will be assessed at baseline (i.e., at the start of the intervention)

• Childhood adverse events

  Childhood adverse events will be assessed at baseline (i.e., at the start of the intervention)

Study Arms (2)

Enhanced Facebook Condition

EXPERIMENTAL

The enhanced Facebook group will be moderated by clinicians and offer psychosocial pain management techniques.

Behavioral: Enhanced Facebook Condition

Control Facebook Condition

ACTIVE COMPARATOR

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

Interventions

Enhanced Facebook Condition BEHAVIORAL

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.

Enhanced Facebook Condition

Control Facebook Condition BEHAVIORAL

The control condition will instruct participants to offer mutual support and will not offer psychosocial intervention.

Control Facebook Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Terminal illness such as cancer
• Active psychosis (e.g., hallucinations, delusions)

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

• Tankha H, Pester BD, Brumley KM, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. A mixed-methods investigation into the us versus them mentality in Facebook groups for chronic pain. Health Psychol. 2023 Jul;42(7):460-471. doi: 10.1037/hea0001289. Epub 2023 May 4.

  PMID: 37141005 DERIVED

• Pester BD, Tankha H, Cano A, Tong S, Grekin E, Bruinsma J, Gootee J, Lumley MA. Facing Pain Together: A Randomized Controlled Trial of the Effects of Facebook Support Groups on Adults With Chronic Pain. J Pain. 2022 Dec;23(12):2121-2134. doi: 10.1016/j.jpain.2022.07.013. Epub 2022 Sep 9.

  PMID: 36096353 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor and Director of Clinical Psychology Training

Model Details: 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).

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 8, 2019
• Study Start: September 27, 2019
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)