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Completed

NCT Number: NCT03265210

A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. The investigators will recruit 60 adults from Weill Cornell Medical Associates primary care practices; participants will be randomized to either Relief (a 9 session behavioral intervention) or usual care/referral for mental health care. Research assessments are conducted with both groups at study entry (Baseline), 6, 9, and 12 weeks.

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Key information

Conditions

Chronic Pain Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iris Cantor Men's & Women's Health Centers, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 years
  • PHQ-9 greater than or equal to 10
  • Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
  • Capacity to consent

Exclusion criteria

  • DSM-5 Axis 1 other than depression and anxiety disorders
  • Montreal Cognitive Assessment (MoCA) < 24
  • Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4
  • Severe or life-threatening medical illness.
  • Patients on psychotropics, opioids or benzodiazepines will be included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance abuse disorders

Treatment and study plan

RELIEF

Behavioral

A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.

Primary outcomes

  1. Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline, 6, 9, and 12 weeks

    The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms.

  2. Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline, 6, 9, and 12 weeks

    The RMDQ includes a scale assessing how much pain the participant has experienced in the past week, with 0 indicating no pain and 10 indicating pain as bad as he/she can imagine; scores will be listed under domain 1. In addition, the RMDQ also includes a series of questions related to pain disability, with 0 indicating no pain-related disability, and 24 indicating severe pain-related disability; scores will be listed under domain 2.

  3. Client Satisfaction Questionnaire (CSQ)

    Time frame: 12 weeks

    A questionnaire that evaluates participants' satisfaction with treatment; ranging from 1 (needs have not been met/dissatisfied) to 4 (almost all needs have been met/very satisfied).

    Domain 1 measures met needs. Scores range from 0-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 0-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 0-4 and higher scores indicate greater willingness to return.

Secondary outcomes

  1. Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)

    Time frame: Daily for 12 weeks

    The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value. PAM uses photos that user selects and map it to arousal (y-axis) and valence(x-axis). Domain 1 is derived from PAM using y-axis (column score): (low activation to high activation): takes on discrete values ranging from 1 - 5. Domain 2 is derived from PAM using x-axis (row score): (unpleasurable to pleasurable or negative to positive): takes on discrete values ranging from 1 - 4.

  2. Activities Monitoring

    Time frame: Daily for 12 weeks

    Activities monitoring through a phone application; measuring distance in meters covered daily by the participant during the week.

  3. Activities Monitoring

    Time frame: Daily for 12 weeks

    Activities monitoring through a phone application; measuring number of places visited daily during the week. Data is based on the total uptime of the location stream (unit is continuous seconds).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

"Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care

Acronym: Relief

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2017
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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