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Integrated Weight and Pain Management for Obesity and Chronic Pain (STOP Trial)

N/A

Waitlist Available

Led By Elizabeth A Janke, PhD

Research Sponsored by University of the Sciences in Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic, non-cancer pain (pain at a level ≥ 4 on a scale of 0-10 on a majority of the days for 6 months or more prior to study participation)

Be older than 18 years old

Must not have

Have an unstable medical or psychiatric condition

Non-fluent in spoken or written English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an integrated approach to treating obesity and pain results in better outcomes than treating each condition separately. All participants will receive some form of treatment, with the type of treatment they receive determined by chance.

Who is the study for?

The STOP Trial is for adults over 18 with a BMI of 25 or higher who have chronic, non-cancer pain (pain level ≥4 for most days in the past 6 months). It's not suitable for those with unstable medical/psychiatric conditions, substance abuse issues, bulimia, non-English speakers, recent/current pregnancy, significant cognitive impairments, or if they're already in similar programs.

What is being tested?

This trial tests whether integrated behavioral treatments can help people who are overweight and suffer from chronic pain. Participants will be randomly assigned to one of three groups: standard weight loss treatment; standard pain management treatment; or an integrated approach targeting both weight loss and pain.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, side effects may include discomfort from lifestyle changes such as dieting and exercise. Psychological distress could also occur due to addressing chronic pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic pain at a level of 4 or higher for over 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable medical or mental health conditions.

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I am not fluent in English.

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I have significant thinking or movement problems that prevent me from participating in treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain intensity from baseline to 12 months

Change in weight from baseline to 12-months

Secondary study objectives

Change in pain disability from baseline to 12 months

Change in quality of life from baseline to 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: STOP InterventionExperimental Treatment1 Intervention

The STOP treatment includes content designed to simultaneously and explicitly target both chronic pain and obesity. Treatment components are drawn from evidence-based interventions for chronic pain and obesity, separately.

Group II: Standard Care Pain (SCP)Active Control1 Intervention

The chronic pain intervention is focused around reconceptualization of pain, decreasing catastrophizing, and increasing self-efficacy for pain. This content has been chosen because of its demonstrated effectiveness and importance in non-pharmacological interventions to improve pain management.

Group III: Standard Care Weight (SCW)Active Control1 Intervention

The weight loss intervention includes content focused around nutrition and eating habits, stimulus control and behavioral change, and physical activity. This content has been chosen because of its demonstrated effectiveness and importance in behavioral interventions to reduce weight.

0 / 4Eligibility criteria met