The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/6/2019 |
| Start Date: | June 2015 |
| End Date: | May 2019 |
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.
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.
Inclusion Criteria: Primary diagnosis of back pain and schedule to undergo an epidural
steroid injection. :
1. ages 18 to 80;
2. able to read/understand English and give consent;
3. willing and able to comply with all aspects of study procedures;
4. if on antidepressants, medications stable for ≥4 weeks prior to study;
5. 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);
6. if on pain medications, medications stable for ≥4 weeks prior to study and no plans to
switch medications during the 30-day study period.
Exclusion Criteria: Participants may meet all criteria above, but will be excluded under
the following additional conditions:
1. 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;
2. currently undergoing psychotherapeutic care at the Back & Pain Center;
3. 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.
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