Treatment Comparison of Cbt and Ssri in Depression
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AbstractBackground: Depression is a key contributor of disease, with unipolar major depression disorder (UMMD) being one of the most widespread and devastating.  Aim: Compare efficacy of a combined treatment to mono-psychotherapy on severity of depression symptoms in UMDD participants.  Hypothesis: The CBT+SSRI treatment group will result in increased occurrence of remission compared to the CBT+placebo treatment group following a 12 month maintenance program.  Method: 100 newly diagnosed adult UMDD patients will participate in a 12month randomised, double-blind, between-subject study. They will be assigned to either CBT+placebo or CBT+SSRI treatment group and depression severity will be assessed by psychiatrist using Hamilton Rating Scale for Depression (HRSD17). Results: Total mean score on HRDS17 will be lower for CBT+SSRI group compared to CBT+placebo group. Implications: Maintenance therapy combining CBT+SSRI has significant efficacy in improving remission of depression in UMDD patients. Thus clinically maintenance treatment of UMDD should include combined therapies for increased success.  The Efficacy of Maintenance Treatment for Unipolar Major Depressive Disorder: CBT vs CBT with SSRIDepression is a major contributor to the overall global burden of disease (Ferrari et al., 2013) and is predicted to be one of the primary cause of disability before 2030 (Karyotaki et al., 2016; Mathers & Loncar, 2006).Unipolar major depressive disorder (UMDD) is a change in mood (sadness or irritability), a loss of interest or pleasure in daily activities and is accompanied by several psycho-physiological changes, including disturbances in sleep and appetite, for more than two weeks (Belmaker  & Agam 2008). MDD is among the most prevalent and debilitating forms of depression (Kessler et al., 2005) with high service use (Cuijpers et al., 2014). The greatest indicator of future episodes is failure to attain full recovery/remission (Craighead & Dunlop, 2014). Reducing depressive symptoms is unsatisfactory and remission should be obtained (Hollon et al., 2014). Therefore research into the efficacy of long-term maintenance treatment outcomes on achieving remission for UMDD patients is required. Research shows pharmacotherapies yield little difference between antidepressant medication (ADM) (Craighead & Dunlop, 2014; Hollon et al., 2006). However others state serotonin reuptake inhibitors (SSRIs) to be superior to tricyclic antidepressants (TCAs) (Cuijpers et al., 2014) with SSRIs having improved tolerance (Hollon et al., 2006; Von Wolff, Hölzel, Westphal, Härter, & Kriston, 2013). Thus SSRIs are recommended for first-line AMD treatments for UMDD (Craighead & Dunlop, 2014). Cognitive-behavioural psychotherapy (CBT) and interpersonal psychotherapy (IPT) have been consistently identified as the most efficacious for treating depression (Craighead & Dunlop, 2014; Luty et al., 2007). Hollon et al. (2006) found both IPT and CBT to be effective, with CBT only improving stability of symptoms or remission. Other studies have also proposed that CBT improves recovery in MDD (G. A. Fava et al., 2014; Stangier et al., 2013). Therefore when the objective of treatment is remission, CBT is the better psychotherapy to use.
Craighead and Dunlop (2014) meta-analyse concluded that only 30–40% of patients with MDD treated with any type of monotherapy will achieve remission. Even highly effective pharmacotherapy administered for a  12–15 months maintenance treatment have relapse rates exceeding 50% (Hollon et al., 2005). Maintenance treatment “aims at preventing future recurrence of the depressive disorder” while acute treatment “aims at alleviating the symptoms of an active depression” (Karyotaki et al., 2016). For acute treatment combined CBT and pharmacotherapy (72.6%) improved remission rates from MDD compared to pharmacotherapy alone (62.5%) (Hollon et al., 2014; Karyotaki et al., 2016) though it failed to do so for combined treatment compared to psychotherapy alone (Karyotaki et al., 2016). Therefore CBT+pharmacotherapy is better than pharmacotherapy alone, however it is inconclusive for combined treatment compared to psychotherapy alone. Jarrett et al. (1998) showed by adding a CBT maintenance treatment of monthly sessions, reduced relapse and recurrence risk  from 50% to 27% at 12 months..Prior research has examined a psychotherapy/pharmacotherapy combination versus psychotherapy for acute treatment while only one study (Frank et al., 1990) has used this combination for maintenance treatment. Frank et al. (1990)  found combined therapy (IPT+Imipramine Hydrochloride; IH) to be more effective compared to IPT-alone, control and IH-alone. While IPT increases relapse presentation time, CBT enhances remission time (Hollon et al., 2006) however no psychotherapy/pharmacotherapy versus psychotherapy maintenance studies have used CBT. Furthermore SSRIs are first-line agents and are superior to TCAs (IH) (Craighead & Dunlop, 2014). Therefore this study aims to determine the efficacy of combining CBT+SSRI in comparison to CBT+placebo on remission. It is hypothesised that the combined CBT+SSRI treatment will show increased instances of remission over the CBT+placebo treatment following the 12months maintenance program for UMDD. Remission is defined by reduction of  points on the Hamilton Rating Scale for Depression (HRSD17) (Hamilton, 1960) for  a period of ≥ 2 successive months. MethodParticipantsQuote-sampling will be used to obtain 50 female and 50 male participants, aged between 18-45 years. Participants will be recruited Australia-wide through doctor referrals. Inclusion criteria is (1) new UMDD diagnoses as per DSM-V criteria, (2) have received no previous or current treatment, psychotherapy and/or pharmacotherapy, (3) a score ≥ 9 on HRSD17. Exclusion criteria will be (1) anyone requiring acute treatment, (2) medical exclusions regarding CBT or SSRI medication. DesignThe independent variable, treatment type, will consist of two levels: CBT+placebo and combined CBT+SSRI. The dependent variable is severity of depression symptoms, measured using HRSD17 total mean score of ≤ 7 (remission), across both conditions. This is a between-subject design that will compare the two groups for 52weeks. MaterialsDepression will be assessed by practitioners using the HRSD17, each 17-item score compares to a corresponding descriptor. Nine items use a five-point scale, ranging from 0= absence of symptom and 4= severe symptoms (eg. Suicide; 0= absent, 4= attempts at suicide). Other eight items use a three-point scale, from 0=absence of symptom to 2=frequent symptoms (eg. Insomnia early; 0=no difficulty falling asleep, 2=complains of nightly difficulty falling asleep). Total score equals combined item-scores and ranges from 0-54.