Back Pain, Depression
Conditions
Keywords
Geriatric psychiatry, Aged, Elderly, Venlafaxine, Self efficacy, Pain, Psychotherapy, Effexor
Brief summary
The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or non-response?
Detailed description
The primary aims of the study are: 1. To test the efficacy of higher-dose Venlafaxine and Problem Solving Therapy for Depression and Pain (VEN/PST-DP) in reducing depression and pain. 2. To test the efficacy of higher-dose VEN/PST-DP in reducing back-related disability and improving physical functioning. Primary Hypotheses: 1. During the 14 weeks of step 2, patients receiving VEN/PST-DP, compared to those receiving VEN/SM, will respond faster and have a higher rate of response. 2. During the 14 weeks of phase 2, patients receiving VEN/PST-DP, compared to those receiving VEN/SM, will have better self-reported physical functioning. Secondary Hypothesis: 3. Self-efficacy has been shown to predict treatment outcomes for both depression and pain. We have observed that the self-efficacy for pain management of these patients improves with antidepressant pharmacotherapy. We hypothesize that for subjects assigned to receive treatment with VEN/PST-DP, self-efficacy will mediate treatment response.
Interventions
DRUGHigher-dose venlafaxine
Dosing of venlafaxine will range from 187.5-300 mg/day.
BEHAVIORALSupportive management
Supportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
BEHAVIORALProblem Solving Therapy for Depression and Pain
PST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 60 or older 2. Scores 10 or higher on the Patient Health Questionnaire-9 (PHQ-9). This is consistent with at least moderate depression severity. 3. Endorses low back pain more days than not, of at least moderate severity, for at least the past 3 months. 4. If venlafaxine up to 150 mg/day has been tried for at least 6 weeks, subjects must have been \*completely\* unresponsive for both depression and low back pain (based on subject report). 5. During this episode of CLBP, must have tried without continued success any of the following: 1) prescription or over the counter analgesics, 2) physical therapy, 3) acupuncture, 4) injection therapy, 5) had back surgery, 6) multidisciplinary pain program, 7) psychological treatment for chronic pain such as cognitive behavioral therapy or biofeedback, or 8) any other physician-prescribed treatment for chronic low back pain. Upon meeting, after obtaining written informed consent, the following inclusion criteria are administered to determine protocol-eligibility: 1. Repeat PHQ-9 with score 2. Current depression (major depression, partial remission of major depression, minor depression, or dysthymia) diagnosed with the PRIMEMD 3. 20-item Numeric Rating Scale for low back pain 4. The Montreal Cognitive Assessment (MoCA). Eligibility requires score of at least 24 5. No history of alcohol/substance abuse or dependence for the past six months. If subjects took more analgesics than prescribed for CLBP but there was no other evidence of abuse, they will be included. Alcohol and substance abuse will be assessed with the MINI-International Neuropsychiatric Interview.
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization | 14 weeks | The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks | Baseline and 14 weeks | Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Improvement of 30% is clinically meaningful |
| Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks | Baseline and 14 weeks | Change in SPPB scores from randomization to 14 weeks for both arms. The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Intervention Arm Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)
Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks. | 68 |
| Active Control Higher-dose venlafaxine and supportive management (SM)
Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks. | 71 |
| Total | 139 |
Baseline characteristics
| Characteristic | Active Control | Study Intervention Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 51 Participants | 89 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 17 Participants | 50 Participants |
| Age, Continuous | 69.90 years STANDARD_DEVIATION 8.73 | 70.81 years STANDARD_DEVIATION 7.9 | 70.34 years STANDARD_DEVIATION 8.32 |
| Region of Enrollment United States | 71 Participants | 68 Participants | 139 Participants |
| Sex: Female, Male Female | 45 Participants | 41 Participants | 86 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 71 |
| serious Total, serious adverse events | 0 / 68 | 0 / 68 |
Outcome results
Primary
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores \< or = to 5 AND Numeric Rating Scale for pain (NRS) \> or = 30% reduction from study entry.
Time frame: 14 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Intervention Arm | Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization | 28 Participants |
| Active Control | Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization | 28 Participants |
95% CI: [0.63, 1.8]
Secondary
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Improvement of 30% is clinically meaningful
Time frame: Baseline and 14 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Study Intervention Arm | Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks | -3.67 units on a scale |
| Active Control | Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks | -3.20 units on a scale |
p-value: 0.49Mixed Models Analysis
Secondary
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
Change in SPPB scores from randomization to 14 weeks for both arms. The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance
Time frame: Baseline and 14 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Study Intervention Arm | Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks | 0.49 units on a scale |
| Active Control | Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks | 0.54 units on a scale |
p-value: 0.88Mixed Models Analysis