Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Milnacipran
Brief Summary: Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers.

We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).


Options:
A: Arm Label: CBT and milnacipran; Type: EXPERIMENTAL; Interventions: Other: CBT and milnacipran | Arm Label: CBT and placebo; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: CBT with a placebo | Arm Label: Educational with milnacipran; Type: ACTIVE_COMPARATOR; Interventions: Drug: Educational with milnacipran | Intervention Type: OTHER; Name: CBT and milnacipran; Assigned to Arm(s): CBT and milnacipran | Intervention Type: BEHAVIORAL; Name: CBT with a placebo; Assigned to Arm(s): CBT and placebo | Intervention Type: DRUG; Name: Educational with milnacipran; Assigned to Arm(s): Educational with milnacipran
B: Arm Label: Duloxetine 30 milligrams (mg); Type: EXPERIMENTAL; Interventions: Drug: Duloxetine 30 milligrams (MG) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Oral Tablet | Arm Label: Duloxetine 60 milligrams (mg); Type: EXPERIMENTAL; Interventions: Drug: Duloxetine 60 milligrams (MG) | Intervention Type: DRUG; Name: Duloxetine 30 milligrams (MG); Assigned to Arm(s): Duloxetine 30 milligrams (mg) | Intervention Type: DRUG; Name: Duloxetine 60 milligrams (MG); Assigned to Arm(s): Duloxetine 60 milligrams (mg) | Intervention Type: DRUG; Name: Placebo Oral Tablet; Assigned to Arm(s): Placebo
C: Arm Label: milnacipran; Type: EXPERIMENTAL; Interventions: Drug: Milnacipran | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Milnacipran; Assigned to Arm(s): milnacipran | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo
D: Arm Label: Imipramine treatment; Type: EXPERIMENTAL; Interventions: Drug: Imipramine treatment | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Imipramine treatment; Assigned to Arm(s): Imipramine treatment | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A