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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04290845
• Other study ID #: 19-10020967
• Secondary ID: 5P50MH113838
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Relief-Hybrid
A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.

Locations

Country	Name	City	State
United States	Iris Cantor Men's and Women's Health Centers	New York	New York
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6, 9, and 12 weeks
Primary	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.	Baseline, 6, 9, and 12 weeks
Primary	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.	Daily for 12 Weeks
Secondary	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"	Baseline, 6, 9, and 12 weeks
Secondary	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.	Baseline, 6, 9, and 12 weeks
Secondary	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).	Daily for 12 weeks
Secondary	Pain, as measured by the Pain Likert Scale	This scale rates current pain, ranging from 0 (no pain) to 10 (worst pain possible).	Daily for 12 weeks
Secondary	Stress, as measured by the Stress Likert Scale	This scale rates current stress, ranging from 0 (no stress at all) to 10 (great stress).	Daily for 12 weeks
Secondary	Activities Monitoring	Activities monitoring through a phone application; measuring distance covered daily by the participant during the week.	Daily for 12 Weeks
Secondary	Activities Monitoring	Activities monitoring through a phone application; measuring number of places visited daily during the week.	Daily for 12 Weeks