Chronic Pain, Depression
Conditions
Keywords
Chronic Pain, Depression, Primary Care, Older Adults, Middle Aged
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.
Interventions
BEHAVIORALRelief-Hybrid
A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants will be blinded as to who is receiving Relief-Hybrid and who is receiving Usual Care.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| Activities Monitoring | Daily for 12 Weeks | Activities monitoring through a phone application; measuring distance covered daily by the participant during the week. |
| 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). |
| 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). |
Countries
United States
Outcome results
None listed