SPARK for Pain and Depression

(SPARK Trial)

Overseen By Catherine Clair, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Frequent hospitalizations, Physical therapy, Terminal diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help older adults manage pain and depression through a program called SPARK, which involves eight home visits from a nurse over 12 weeks. The goal is to improve mood and reduce pain, enabling participants to enjoy activities they currently find difficult. Ideal participants experience persistent pain affecting daily activities, live in Central Maryland, and frequently feel depressed. Participants will either start the SPARK program immediately or join later from a waitlist. As an unphased trial, this study offers a unique opportunity to access a potentially beneficial program designed to enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SPARK intervention is safe for older adults with pain and depression?

Research has shown that SPARK, a therapy based on cognitive-behavioral techniques, has been tested in several studies and is generally well-received. For instance, a study on a similar digital SPARK program for teenagers found it easy to use and liked by participants. They reported no major side effects, indicating safety. Another study on a related program called SPARX demonstrated it helped reduce depression without major safety issues.

The SPARK program in this trial is non-invasive, meaning it doesn't involve surgery or medication, and includes nurse visits to assist with mood and pain. This type of treatment typically carries fewer risks than those involving medication. For any concerns, discussing them with the trial organizers or a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SPARK because it offers a fresh approach to tackling both pain and depression. Unlike traditional treatments that often rely on medications targeting neurotransmitter levels, SPARK focuses on integrating behavioral and psychological strategies to address these conditions. This method could provide a more holistic approach, potentially reducing reliance on pharmaceuticals and their associated side effects. By targeting both pain and depression simultaneously, SPARK has the potential to improve overall quality of life more effectively than treatments addressing these issues separately.

What evidence suggests that the SPARK intervention is effective for pain and depression?

Research has shown that the SPARK program, which participants in this trial may receive, can help reduce symptoms of depression. One study found that individuals using a similar SPARK program experienced a significant drop in their depression scores compared to those receiving regular treatment. Specifically, their mood improved, with an average decrease of over 10 points on a depression scale. These findings suggest that SPARK could effectively improve mood and manage depression symptoms. Although these results come from different groups, they highlight SPARK's potential to assist individuals dealing with depression and related issues. ^{1 4 5 6 7}

Who Is on the Research Team?

Janiece L Taylor, PhD

Principal Investigator

Johns Hopkins School of Nursing

Catherine Clair, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for older adults aged 50 and above who are experiencing pain, depression, and mobility issues. Participants will receive home visits from nurses to assist with their pain and mood.

Inclusion Criteria

Living in the community

Living in Central Maryland

Scoring a 5 or higher on the PHQ-9 (depression measure) at least two times during a two-week period (screening call and first data collection visit)

Exclusion Criteria

I have been hospitalized more than 3 times in the past year.

Participating in physical therapy

Having a terminal diagnosis (less than 1 year expected survival)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SPARK intervention, which includes 8 weekly nurse visits in participants' homes to help with pain and mood management

12 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in pain interference, pain intensity, depressive symptoms, and physical function

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPARK

Trial Overview

The SPARK intervention is being tested, which involves eight nurse-led home visits aimed at helping participants manage their pain and improve their mood.

How Is the Trial Designed?

Group I: SPARK Intervention Arm Experimental Treatment 1 Intervention

The intervention group will receive the intervention for 12 weeks. The wait list control group will have outcomes measured but will not receive the intervention at this time.

Group II: Wait List Control Arm Active Control 1 Intervention

Once the intervention group has completed the intervention the wait list control group will complete the intervention.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10882470/

Preliminary Efficacy of a Digital Intervention for Adolescent ...

The primary outcome was a between-group (Spark vs control) difference in the change in depression symptoms from baseline to postintervention, as measured by the ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/22517917/

The effectiveness of SPARX, a computerised self help ...

Post-intervention, there was a mean reduction of 10.32 in SPARX and 7.59 in treatment as usual in raw scores on the children's depression rating ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07119268

Study Details | NCT07119268 | SPARK Healthy Sleep

The study evaluates feasibility, acceptability, and preliminary effectiveness of a smartphone-delivered intervention combining stigma reduction and cognitive ...

4.

scholarcommons.scu.edu

scholarcommons.scu.edu/psych/379/

"Preliminary Efficacy of a Digital Intervention for Adolescent ...

The primary outcome was a between-group (Spark vs control) difference in the change in depression symptoms from baseline to postintervention, as ...

5.

researchgate.net

researchgate.net/publication/224770311_The_effectiveness_of_SPARX_a_computerised_self_help_intervention_for_adolescents_seeking_help_for_depression_Randomised_controlled_non-inferiority_trial

(PDF) The effectiveness of SPARX, a computerised self ...

Post-intervention, there was a mean reduction of 10.32 in SPARX and 7.59 in treatment as usual in raw scores on the children's depression rating ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10262850/

A CBT-based mobile intervention as an adjunct treatment ...

A virtual randomized controlled trial was used to assess the feasibility and acceptability of a 5-week, self-guided, cognitive behavioral therapy (CBT)-based ...

7.

bmcpsychology.biomedcentral.com

bmcpsychology.biomedcentral.com/articles/10.1186/s40359-025-03465-7

Social prescriptions for advancing resilience in kids (SPARK)

Objective two will examine the outcomes of social prescribing for youth experiencing MH difficulties. This will include an assessment of its ...