The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain

NCT02476812 | Completed Results

• 1 other identifier: HUM00100068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research staff to be invited to participate in this study. Those interested will be asked to arrive 45 minutes before their regularly scheduled appointment. At that time they will learn more about the study and provide informed consent if they choose to participate. Participants will then complete the study questionnaires and be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group (n = 100). All participants will receive the usual treatment provided at the Back \& Pain Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after that (Day 90), participants will complete the same questionnaires by mail. The primary outcome will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period, the patients in the Wait List control will be offered the Positive Piggy Bank intervention and will be asked to complete one more set of questionnaires at 30 days by mail.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in Functional Status Measured by Oswestry Disability Questionnaire

  This questionnaire consists of 10 questions. Participants will select one of six options for each question, ranging from no extra pain (0) to the worst pain imaginable (5). Total scores can range from 0 to 50 points, where higher scores indicate higher pain intensity and more significant areas of disability.

  Baseline (T1), 30 days (T2), and 90 days (T3)

Secondary Outcomes (10)

• Change in Pain Severity - Brief Pain Inventory (BPI)

  approximately 30 days

• Change in Fatigue. PROMIS Fatigue - Short Form 4a

  Baseline (T1), approximately 90 days (T3)

• Change in Perceived Sleep Problems - PROMIS -Sleep Disturbance (PROMIS-SD4a)

  Baseline (T1) approximately 90 days (T3)

• Change in Depression and Anxiety- Hospital Anxiety and Depression Scale (HADS)

  Baseline (T1), approximately 90 days (T3)

• Change in Happiness - Subjective Happiness Scale.

  Baseline (T1) to approximately 90 days (T3)

Study Arms (2)

Positive Piggy Bank

EXPERIMENTAL

Patients randomized to this group will meet with a research assistant who provides an overview of the intervention, explains the rationale for this treatment, and then gives the patients the instructions, piggy bank, and currency slips. Participants in this group will receive instructions. At the end of the monitoring period, 30 days, they are to "close their account" by opening the piggy bank and reviewing all of the slips of paper. Study personnel will contact patients within 72 hours to answer questions. Participants will also be contacted at 30 days to let patients know that they should read all of their currency slips in one sitting. They are also told that the intervention part of the study is over and are asked they complete the follow up questionnaires. Then, study personnel will call again to let the participant know that the second set of questionnaires will be arriving by mail.

Behavioral: Positive Piggy Bank

Waitlist Control

NO INTERVENTION

The control group will serve to show the relative benefits of the Positive Piggy Bank intervention. Those in the control group who meet study criteria will also receive regular care after their epidural steroid injection (e.g., physician visits, medication maintenance, standard patient education). These patients will follow the same questionnaire follow up procedures as listed above including phone calls. The phone call at 72 hours will be to simply thank them for their participation in the study. At the end of the study period, approximately three months, Wait List control patients will also be offered the Positive Piggy Bank intervention along with the supportive phone calls. Should they choose to try the Positive Piggy Bank intervention, they will be required to return to the center to pick up supplies and receive instruction. They will also complete study questionnaires by mail at 30 days to assess intra-individual change.

Interventions

Positive Piggy Bank BEHAVIORAL

Already noted.

Positive Piggy Bank

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18 to 80;
• able to read/understand English and give consent;
• willing and able to comply with all aspects of study procedures;
• if on antidepressants, medications stable for ≥4 weeks prior to study;
• no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g., back surgery, physical therapy, cognitive-behavioral therapy);
• if on pain medications, medications stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period.

You may not qualify if:

• having a known psychotic disorder or the presence of another psychiatric condition (e.g., severe depression, suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study;
• currently undergoing psychotherapeutic care at the Back \& Pain Center;
• other factors that at the discretion of the investigators would adversely affect study participation. We will not exclude participants who undergo unanticipated changes in treatment, but will handle these data as described later.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Back & Pain Center, University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Afton L. Hassett, PsyD
• Organization: Back & Pain Center Clinical Research

afton@med.umich.edu

734-763-5226

Publication Agreements

• PI is Sponsor Employee: Yes

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: Associate Research Scientist

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 19, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2025-12

Locations

US (1)