NCT01752998

Brief Summary

Individuals will be recruited by posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization. Participants will be randomized into a Health Education study arm, and receive 7 individual sessions on general health education, or an Intervention study arm, and receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

4.9 years

First QC Date

December 17, 2012

Last Update Submit

September 15, 2017

Conditions

PainDepressionSubstance Use

Keywords

paindepressionsubstance use

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain, as measured by self-report

    4 months

Secondary Outcomes (2)

  • Depression

    4 months

  • Substance Use

    4 months

Study Arms (2)

TOPPS Intervention

ACTIVE COMPARATOR

Individuals randomized into this arm will receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention, designed to reduce symptoms of pain and depression.

Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)

Health Education

PLACEBO COMPARATOR

Individuals randomized into this arm will receive 7 individual sessions on general health education.

Behavioral: Health Education

Interventions

Treating Opioid Patients' Pain and Sadness (TOPPS)BEHAVIORAL
TOPPS Intervention
Health EducationBEHAVIORAL
Health Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Pain, defined as pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale;
  • Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week";
  • Previous attempt at initial steps of PCP guideline pain care: must have had at least one trial of recommended medication (i.e. acetaminophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs;
  • QIDS score of ≥ 10 (depression severity)
  • If using an antidepressant, the dose must be stable for the previous 2 months;
  • Age 18 or older
  • Has received buprenorphine/naloxone (Suboxone)for at least the last 3 months;
  • Plan to continue buprenorphine/naloxone (Suboxone)for at least 3 months.

You may not qualify if:

  • Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition;
  • Current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, or cocaine;
  • Suicidal ideation or behavior requiring immediate attention;
  • In psychotherapy or in a multidisciplinary pain management program at baseline;
  • Anticipate having surgery in the next 6 months;
  • Pain thought to be due to cancer, infection, inflammatory arthritis, or associated with severe or progressive neurological deficits;
  • SSDI or SSI claim pending;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

PainDepressionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Michael Stein, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 19, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

US(1)