Optimizing Care for Older Adults With Back Pain and Depression (ADAPT)

NCT01124188 Phase 4 COMPLETED Results posted

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?

Details

Lead sponsor	University of Pittsburgh
Phase	Phase 4
Status	COMPLETED
Enrolment	263
Start date	2010-05
Completion	2016-02

Conditions

• Depression
• Back Pain

Interventions

• Higher-dose venlafaxine
• Supportive management
• Problem Solving Therapy for Depression and Pain

Primary outcomes

• 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.

Countries

United States