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

• ClinicalTrials.gov Identifier: NCT04290845
• Recruitment Status: Suspended
• First Posted: March 2, 2020
• Last Update Posted: November 23, 2021
• Sponsor: Weill Medical College of Cornell University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain; Depression	Behavioral: Relief-Hybrid	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Research assistants will be blinded as to who is receiving Relief-Hybrid and who is receiving Usual Care.
• Primary Purpose: Treatment
• Official Title: Relief-Hybrid: A Behavioral Intervention for Depression and Chronic Pain in Primary Care
• Estimated Study Start Date: January 2022
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Relief-Hybrid; Relief-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.	Behavioral: Relief-Hybrid; A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.
No Intervention: Referral to Mental Health/Usual Care; Continuation 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.

Outcome Measures

Primary Outcome Measures :

1. Change in depression 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 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.

3. 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.

Secondary Outcome Measures :

1. Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: Baseline, 6, 9, and 12 weeks ]
   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"
2. Affect, as measured by the Positive and Negative Affect Schedule (PANAS). [ Time Frame: Baseline, 6, 9, and 12 weeks ]
   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.
3. Mood, as measured by the Mood Likert Scale [ Time Frame: Daily for 12 weeks ]
   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).
4. Pain, as measured by the Pain Likert Scale [ Time Frame: Daily for 12 weeks ]
   This scale rates current pain, ranging from 0 (no pain) to 10 (worst pain possible).
5. Stress, as measured by the Stress Likert Scale [ Time Frame: Daily for 12 weeks ]
   This scale rates current stress, ranging from 0 (no stress at all) to 10 (great stress).
6. Activities Monitoring [ Time Frame: Daily for 12 Weeks ]
   Activities monitoring through a phone application; measuring distance covered daily by the participant during the week.
7. Activities Monitoring [ Time Frame: Daily for 12 Weeks ]
   Activities monitoring through a phone application; measuring number of places visited daily during the week.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, New York

Weill Cornell Internal Medical Associates (WCIMA)

New York, New York, United States, 10021

Iris Cantor Men's and Women's Health Centers

New York, New York, United States, 10065

Irving Sherwood Wright Center

New York, New York, United States, 10075

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

White Plains, New York, United States, 10605

Sponsors and Collaborators

Weill Medical College of Cornell University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Dimitris Kiosses, PhD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT04290845
• Other Study ID Numbers: 19-10020967; 5P50MH113838 ( U.S. NIH Grant/Contract )
• First Posted: March 2, 2020
• Last Update Posted: November 23, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Time Frame: Data will be available as per NIH's data sharing policy.
• Access Criteria: Access criteria is determined by NIH and can be requested by applying online.
• URL: https://nda.nih.gov/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:

Chronic Pain; Depression; Primary Care; Older Adults; Middle Aged

Additional relevant MeSH terms:

Chronic Pain; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Pain; Neurologic Manifestations