Separate and combined effects of CBT and drug therapy: Psychosocial outcomes in the treatment of chronic tension-type headache

Abstract

This study reports data from the Treatment of Tension-type Headache clinical trial evaluating tricyclic antidepressant medication (AM), cognitive-behavioral stress-management therapy (SMT) and their combination (AM + SMT) versus pill placebo (PL) in the treatment of chronic tension-type headache (CTTH). 203 patients (mean age = 37; 76% female; mean headache days/mo. = 26) with an International Headache Society diagnosis of CTTH were randomized to the 4 conditions. Following a 2-month dose adjustment/ SMT administration period participants were followed for 12 months. Participants completed the Headache Self-Efficacy Scale (HSE) and Headache-Specific Locus of Control (HSLC) at 8 assessment points and the Headache Disability Inventory (HDI), Beck Depression Inventory (BDI), Trait Anxiety Scale (TAS), and Medical Outcomes Study SF20 (MOSSF20) at 4 assessment points.. On the HSE, and three HSLOC subscales significant SMT X Time interactions (p < .001) revealed that participants in the two SMT groups showed significant change on all 4 measures by the end of the first 4 weeks of treatment with changes maintained through the 12 month follow-up. In contrast, the AM & PL groups showed no change on these measures. Similarly, on the HDI a significant SMT X Time interaction revealed significant reductions in headache-related disability in the SMT groups, but not the AM & PL groups. On the BDI, TAS and MOSSF20 only Time effects were significant indicating no treatment differences. Participants with a mood disorder diagnosis had higher BDI scores and showed greater reductions in BDI scores than participants with no diagnosis. Although the three active treatments were equally effective in reducing tension-type headache activity relative to placebo, the three treatments differed in their impact on psychosocial measures. SMT, but not drug therapy altered participants’ beliefs about the variables controlling their headaches and their ability to manage headache episodes. This study reports data from the Treatment of Tension-type Headache clinical trial evaluating tricyclic antidepressant medication (AM), cognitive-behavioral stress-management therapy (SMT) and their combination (AM + SMT) versus pill placebo (PL) in the treatment of chronic tension-type headache (CTTH). 203 patients (mean age = 37; 76% female; mean headache days/mo. = 26) with an International Headache Society diagnosis of CTTH were randomized to the 4 conditions. Following a 2-month dose adjustment/ SMT administration period participants were followed for 12 months. Participants completed the Headache Self-Efficacy Scale (HSE) and Headache-Specific Locus of Control (HSLC) at 8 assessment points and the Headache Disability Inventory (HDI), Beck Depression Inventory (BDI), Trait Anxiety Scale (TAS), and Medical Outcomes Study SF20 (MOSSF20) at 4 assessment points.. On the HSE, and three HSLOC subscales significant SMT X Time interactions (p < .001) revealed that participants in the two SMT groups showed significant change on all 4 measures by the end of the first 4 weeks of treatment with changes maintained through the 12 month follow-up. In contrast, the AM & PL groups showed no change on these measures. Similarly, on the HDI a significant SMT X Time interaction revealed significant reductions in headache-related disability in the SMT groups, but not the AM & PL groups. On the BDI, TAS and MOSSF20 only Time effects were significant indicating no treatment differences. Participants with a mood disorder diagnosis had higher BDI scores and showed greater reductions in BDI scores than participants with no diagnosis. Although the three active treatments were equally effective in reducing tension-type headache activity relative to placebo, the three treatments differed in their impact on psychosocial measures. SMT, but not drug therapy altered participants’ beliefs about the variables controlling their headaches and their ability to manage headache episodes.