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

Not Applicable

Withdrawn

• Conditions: Chronic Pain; Depression
• Interventions: Behavioral: Relief-Hybrid

• Registration Number: NCT04290845
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Study Start: 2023-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relief-Hybrid	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.

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)	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)	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)	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

Name	Time	Method
Affect, as measured by the Positive and Negative Affect Schedule (PANAS).	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	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).
Activities Monitoring	Daily for 12 Weeks	Activities monitoring through a phone application; measuring number of places visited daily during the week.
Pain, as measured by the Pain Likert Scale	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	Daily for 12 weeks	This scale rates current stress, ranging from 0 (no stress at all) to 10 (great stress).
Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)	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"

Trial Locations

Locations (4)

Irving Sherwood Wright Center; 🇺🇸 New York, New York, United States

Weill Cornell Internal Medical Associates (WCIMA); 🇺🇸 New York, New York, United States

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine; 🇺🇸 White Plains, New York, United States

Iris Cantor Men's and Women's Health Centers; 🇺🇸 New York, New York, United States