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Chronic PainNCT04290845

A Behavioral Intervention for Depression and Chronic Pain in Primary Care (Relief-Hybrid)

A study testing Relief-Hybrid in people with Chronic Pain and Depression, run by Weill Medical College of Cornell University at 4 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Older and middle-aged depressed-pain patients: a) are mainly treated in primary care practices; and b) are often prescribed medication, which… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Chronic Pain, Depression
What is being tested?
Relief-Hybrid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesUnited States
Study dates
Feb 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 50 years or older
  • PHQ-9 score greater or equal to 10
  • Chronic pain (non-cancer related, most days over the past 3 months)
  • Capacity to consent

Who cannot join

  • DSM-5 Axis 1 diagnoses other than depression and anxiety disorders
  • Montreal Cognitive Assessment (MoCA) < 24
  • Active suicidal ideation (MADRS item #10 greater 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Weill Cornell Internal Medical Associates (WCIMA)

    New York, New York, 10021

  • Iris Cantor Men's and Women's Health Centers

    New York, New York, 10065

  • Irving Sherwood Wright Center

    New York, New York, 10075

  • Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

    White Plains, New York, 10605

Other trials in United States

About this study

Official title: Relief-Hybrid: 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. Older and middle-aged depressed-pain patients: a) are mainly treated in primary care practices; and b) are often prescribed medication, which increases the risk for addiction to opioids and benzodiazepines. Despite the need and desire by the patients and providers for primary care behavioral intervention, behavioral interventions are scarce in primary care.

To address this need, Relief-Hybrid was created. Subjects are randomized to either the Relief-Hybrid intervention or to Referral to Mental Health/Usual Care. Subjects in both arms will complete research assessments at 6, 9, and 12 weeks. Subjects in the Relief-Hybrid arm will receive 5 weekly sessions with the study therapist (licensed social workers, LCSWs) and 4 self-administered, mobile technology-assisted sessions.

Being tested
Relief-Hybrid
Keywords
Chronic Pain, Depression, Primary Care, Older Adults, Middle Aged
Medical subject headings
Chronic Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relief-HybridBehavioural

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

Study groups in NCT04290845
Study groupRoleWhat they receive
Relief-HybridExperimentalRelief-Hybrid relies on a neurobiological model to simplify its behavioral targets and uses mobile technology to augment its interventions. Relief was co-developed with our primary care partners with the goal to be usable by non-physician clinicians of primary care offices eligible to provide billable services.
Receives: Behavioral: Relief-Hybrid
Referral to Mental Health/Usual CareNo interventionContinuation of medical attention and treatment provided by physicians and other medical professionals at the primary care practice. Referral for mental health based on clinical indication. Participants receive an educational booklet on pain.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)

    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.

    Measured: Baseline, 6, 9, and 12 weeks

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

    The RMDQ includes a scale assessing how much pain the participant has experienced in the past week, with 0 meaning no pain and 10 meaning pain as bad as he/she can imagine.

    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.

    Measured: Baseline, 6, 9, and 12 weeks

  3. Change in Mood, as measured by the Daily Photographic Affect Meter (PAM)

    The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value.

    Measured: Daily for 12 Weeks

Secondary outcomes (7)

  1. Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)

    This assessment contains 32 questions measuring 8 areas of manifestations of emotions, including noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. The scores for the questions associated with each of the 8 domains are averaged, with a score of 0 indicating "Never" and a score of 5 indicating "Always"

    Measured: Baseline, 6, 9, and 12 weeks

  2. Affect, as measured by the Positive and Negative Affect Schedule (PANAS).

    This scale consists of a series of 60 words and phrases and participants rate to what extent they have felt that way in the past week. The words are separated into 13 areas: general negative affect, fear, sadness, guilt, hostility, shyness, fatigue, general positive affect, joviality, self-assurance, attentiveness, serenity, and surprise. The scores range from 1 (very slightly/not at all), to 5 (extremely) for each word and each area is summed for the final score.

    Measured: Baseline, 6, 9, and 12 weeks

  3. Mood, as measured by the Mood Likert Scale

    This scale rates current sadness, ranging from 0 (not sad) to 10 (most sad). It also rates interest or pleasure in doing things, ranging from 0 (no interest or pleasure) to 10 (greatest interest or pleasure).

    Measured: Daily for 12 weeks

  4. Pain, as measured by the Pain Likert Scale

    This scale rates current pain, ranging from 0 (no pain) to 10 (worst pain possible).

    Measured: Daily for 12 weeks

  5. Stress, as measured by the Stress Likert Scale

    This scale rates current stress, ranging from 0 (no stress at all) to 10 (great stress).

    Measured: Daily for 12 weeks

  6. Activities Monitoring

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

    Measured: Daily for 12 Weeks

  7. Activities Monitoring

    Activities monitoring through a phone application; measuring number of places visited daily during the week.

    Measured: Daily for 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study startFeb 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Study was never initiated due to COVID-19. No study participants were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290845
Sponsor's protocol ID
19-10020967
Other IDs
5P50MH113838
Status last verified
Mar 2023
First submitted
27 Feb 2020
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.

Questions about this trial

What is this clinical trial studying?

A study testing Relief-Hybrid in people with Chronic Pain and Depression, run by Weill Medical College of Cornell University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Baseline, 6, 9, and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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