A Behavioral Intervention for Depression and Chronic Pain in Primary Care (Relief-Hybrid)
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|ClinicalTrials.gov Identifier: NCT04290845|
Recruitment Status : Suspended (Temporarily paused by Investigator due to COVID-19. This is not a suspension of IRB approval.)
First Posted : March 2, 2020
Last Update Posted : November 23, 2021
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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"
- 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.
- 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).
- 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).
- 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).
- Activities Monitoring [ Time Frame: Daily for 12 Weeks ]Activities monitoring through a phone application; measuring distance covered daily by the participant during the week.
- Activities Monitoring [ Time Frame: Daily for 12 Weeks ]Activities monitoring through a phone application; measuring number of places visited daily during the week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290845
|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|
|Principal Investigator:||Dimitris Kiosses, PhD||Weill Medical College of Cornell University|