Clinical trial NCT04290845: A Behavioral Intervention for Depression and Chronic Pain in Primary Care (Relief-Hybrid)
Official title: Relief-Hybrid: A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Depression
Keywords: Chronic Pain
Depression
Primary Care
Older Adults
Middle Aged
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Change in Pain-Related Disability, as measured by the Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Change in Mood, as measured by the Daily Photographic Affect Meter (PAM)
timeFrame: Daily for 12 Weeks
Secondary outcomes:
measure: Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Affect, as measured by the Positive and Negative Affect Schedule (PANAS).
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Mood, as measured by the Mood Likert Scale
timeFrame: Daily for 12 weeks
measure: Pain, as measured by the Pain Likert Scale
timeFrame: Daily for 12 weeks
measure: Stress, as measured by the Stress Likert Scale
timeFrame: Daily for 12 weeks
measure: Activities Monitoring
timeFrame: Daily for 12 Weeks
measure: Activities Monitoring
timeFrame: Daily for 12 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Internal Medical Associates (WCIMA)
state: New York
city: New York
country: United States
facility: Iris Cantor Men's and Women's Health Centers
state: New York
city: New York
country: United States
facility: Irving Sherwood Wright Center
state: New York
city: White Plains
country: United States
facility: Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dimitris Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
References: