Ready for Change: Enhancing Motivational Engagement Prior to IIPT

NCT04093921 | Completed

• 1 other identifier: P00033150
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.

Conditions

Chronic Pain

Keywords

chronic pain; pediatric

Outcome Measures

Primary Outcomes (11)

• Length of stay

  length of stay in PPRC program (in weeks)

  PPRC discharge [within 6 months of baseline]

• Functional disability inventory (FDI) total score

  level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

  at PPRC follow up (4-8 weeks post discharge)

• Pain stages of change questionnaire for adolescents (PSOCQ-A)

  readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.

  PPRC admission (within 2 months of baseline)

• Pain stages of change questionnaire for adolescents (PSOCQ-A)

  readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.

  PPRC discharge [within 6 months of baseline]

• Pain stages of change questionnaire for adolescents (PSOCQ-A)

  readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.

  at PPRC follow up (4-8 weeks post discharge)

• Pain stages of change questionnaire for adolescents (PSOCQ-A)

  readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.

  at PPRC follow up (1 year post discharge)

• Modified Adolescent Treatment Engagement Questionnaire

  Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.

  At end of intervention, 4 weeks from baseline

• Chronic Pain Acceptance Questionnaire total score

  Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.

  At PPRC discharge [within 6 months of baseline]

• Chronic Pain Acceptance Questionnaire total score

  Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.

  At PPRC admission [typically within 3 months of baseline]

• Treatment satisfaction inventory

  Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction

  At end of intervention, 4 weeks from baseline

• Readiness Rulers

  Motivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain

  During and at end of the intervention, for the treatment group only

Secondary Outcomes (11)

• Pain intensity

  At PPRC admission (4-6 weeks post baseline)

• Pain intensity

  At PPRC discharge [within 6 months of baseline]

• Functional disability inventory (FDI) total score

  at PPRC discharge [within 6 months of baseline]

• Functional disability inventory (FDI) total score

  at PPRC follow up (1 year post discharge)

• Pain intensity

  At first post-treatment follow up (4-8 weeks post discharge)

Study Arms (2)

Intervention

EXPERIMENTAL

Receive motivational enhancement training based, telehealth-delivered 6-8 session intervention aimed at increasing readiness to engage in pain self-management, in addition to all recommended outpatient treatments.

Behavioral: MET-based therapy; Behavioral: Standard Care

Standard Care

ACTIVE COMPARATOR

Participate in all recommended outpatient pain treatments while awaiting PPRC admission.

Behavioral: Standard Care

Interventions

MET-based therapy BEHAVIORAL

see previous

Intervention

Standard Care BEHAVIORAL

To include all recommended outpatient treatments

Intervention; Standard Care

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient age 8-18 at enrollment
• Presence of chronic pain condition for \> 3 months with moderate or severe disability
• Accepts referral to PPRC and awaiting admission

You may not qualify if:

• Non-English speaking
• No access to device with telehealth capability

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Smith AM, Logan DE. Promoting readiness and engagement in pain rehabilitation for youth and families: Developing a pediatric telehealth motivational interviewing protocol. Paediatr Neonatal Pain. 2021 Oct 28;4(3):125-135. doi: 10.1002/pne2.12063. eCollection 2022 Sep.

  PMID: 36188162 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Those providing care at the PPRC will not know which study arm their patients were in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of psychology services in pain medicine

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 18, 2019
• Study Start: June 15, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

US (1)