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Purpose Major depressive disorder (MDD) disproportionately affects those living with autism spectrum disorder (ASD) and is associated with significant impairment and treatment recidivism. Methods We studied the use of accelerated theta burst stimulation (ATBS) for the treatment of refractory MDD in ASD (3 treatments daily x 10 days). This prospective open-label 12-week trial included 10 subjects with a mean age of 21.5 years, randomized to receive unilateral or bilateral stimulation of the dorsolateral prefrontal cortex. Results One participant dropped out of the study due to intolerability. In both treatment arms, depressive symptoms, scored on the Hamilton Depression Rating Scale scores, diminished substantially. At 12 weeks post-treatment, full remission was sustained in 5 subjects and partial remission in 3 subjects. Treatment with ATBS, regardless of the site of stimulation, was associated with a significant, substantial, and sustained improvement in depressive symptomatology via the primary outcome measure, the Hamilton Depression Rating Scale. Additional secondary measures, including self-report depression scales, fluid cognition, and sleep quality, also showed significant improvement. No serious adverse events occurred during the study. Mild transient headaches were infrequently reported, which are expected side effects of ATBS. Conclusion Overall, ATBS treatment was highly effective and well-tolerated in individuals with ASD and co-occurring MDD. The findings support the need for a larger, sham-controlled randomized controlled trial to further evaluate efficacy of ATBS in this population.

Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo. We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38. Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI −0·23 to 2·58; p=0·10) or mirtazapine (0·01, −1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, −0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39. Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered. UK National Institute of Health Research HTA Programme.

Depression is common in patients with Parkinson's disease, but evidence on the efficacy of antidepressants in this population is lacking. Because depression in patients with Parkinson's disease might be related to dopaminergic dysfunction, we aimed to assess the efficacy of the dopamine agonist pramipexole for treatment of depressive symptoms in patients with Parkinson's disease. We did a 12-week randomised, double-blind, placebo-controlled (1:1 ratio) trial of pramipexole (0·125–1·0 mg three times per day) compared with placebo in patients with mild-to-moderate Parkinson's disease. Patients from 76 centres in 12 European countries and South Africa were included if they were on stable antiparkinsonian therapy without motor fluctuations and had depressive symptoms (15-item geriatric depression scale score ≥5 and unified Parkinson's disease rating scale [UPDRS] part 1 depression item score ≥2). Patients were randomly assigned by centre in blocks of four by use of a randomisation number generating system. Clinical monitors, the principal investigator, and patients were masked to treatment allocation. The primary endpoint was change in Beck depression inventory (BDI) score and all treated patients who had at least one post-baseline efficacy assessment were included in the primary analysis. We also did a pre-specified path analysis with regression models to assess the relation between BDI and UPDRS part 3 (motor score) changes. This trial is registered with ClinicalTrials.gov, number NCT00297778, and EudraCT, number 2005-003788-22. Between March, 2006, and February, 2008, we enrolled 323 patients. Of 296 patients randomly assigned to pramipexole or placebo, 287 were included in the primary analysis: 139 in the pramipexole group and 148 in the placebo group. BDI scores decreased by an adjusted mean 5·9 (SE 0·5) points in the pramipexole group and 4·0 (0·5) points in the placebo group (difference 1·9, 95% CI 0·5–3·4; p=0·01, ANCOVA). The UPDRS motor score decreased by an adjusted mean 4·4 (0·6) points in the pramipexole group and 2·2 (0·5) points in the placebo group (difference 2·2, 95% CI 0·7–3·7; p=0·003, ANCOVA). Path analysis showed the direct effect of pramipexole on depressive symptoms accounted for 80% of total treatment effect (p=0·04). Adverse events were reported in 105 of 144 patients in the pramipexole group and 101 of 152 in the placebo group. Adverse events in the pramipexole group were consistent with the known safety profile of the drug. Pramipexole improved depressive symptoms in patients with Parkinson's disease, mainly through a direct antidepressant effect. This effect should be considered in the clinical management of patients with Parkinson's disease. Boehringer Ingelheim.

Study Objectives: The current archival analyses examine the direct and indirect effects of cognitive behavioral therapy for insomnia (CBT-I) on depression in cancer survivors. Methods: We report on 67 cancer survivors from a 2 × 2 randomized controlled trial of CBT-I and armodafinil for insomnia, after collapsing across the noneffective study medication conditions (armodafinil/placebo) to create CBT-I (yes/no). Depression and insomnia were assessed before, during the 7-week CBT-I intervention, at postintervention, and 3 months later by the Patient Health Questionnaire and the Insomnia Severity Index, respectively. Results: Mean depression at baseline for all participants was 6.44 (standard error = 0.41, range 0–15). Paired t tests showed that depression improved from baseline to postintervention by 48% ( P < .001) in the CBT-I group versus 15% ( P = .016) in the non-CBT-I group. Analysis of covariance controlling for baseline found that participants receiving CBT-I had significantly less depression at postintervention (effect size = −0.62; P = .001), compared to those who did not receive CBT-I. These benefits were maintained at the 3-month follow-up. Spearman rank correlations showed that changes in insomnia severity from baseline to postintervention were significantly correlated with concurrent changes in depression ( r = .73; P < .001). Path analysis revealed that improvement in depression was mediated by improvement in insomnia severity ( P < .001). Conclusions: Our findings provide preliminary support that in cancer survivors, CBT-I reduces depression via improvement in insomnia. Further, this reduction in depression remained stable 3 months after completing CBT-I. This suggests that a CBT-I intervention has a meaningful effect on depression. Clinical Trial Registration: Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy; Identifier: NCT01091974; URL: https://clinicaltrials.gov/ct2/show/record/NCT01091974 Citation: Peoples AR, Garland SN, Pigeon WR, Perlis ML, Wolf JR, Heffner KL, Mustian KM, Heckler CE, Peppone LJ, Kamen CS, Morrow GR, Roscoe JA. Cognitive behavioral therapy for insomnia reduces depression in cancer survivors. J Clin Sleep Med 2019;15(1):129–137.

Biofeedback combined with psychotherapy has been recognized as a potential treatment for patients with functional constipation, anxiety and depression disorder. To validate the therapeutic effect of the biofeedback therapy, 120 patients with a clear diagnosis of functional constipation combined with anxiety and depression disorder were recruited, and then randomly divided into the control group (patients received gastrointestinal medication and anti-anxiety and depression medication) and the treatment group (patients received combined biofeedback and psychotherapy on the basis of the control group’s treatment program). The treatment group was treated with biofeedback exercise twice a day for 7 days, supplemented with psychotherapy for a period of 2 months (half-month intervals for one time). Intestinal medications in the treatment group were stopped after one month of treatment. While for the control group, patients were maintained with gastrointestinal motivational drugs, probiotics, anti-anxiety and depression medications. Both groups reduced the dosage of anxiolytics and depressants after 3 months. The control and the treatment group were both effective and the latter had a more significant effect compared to the former. Moreover, the anxiety/depression symptom for patients in the treatment group was significantly milder than those in the control group. Notably, compared with pre-treatment symptoms, the treatment group showed a significant reduction in Pittsburgh sleep quality index (PSQI) scores in the sixth month (F = 0.008, P  = 0.008). In summary, biofeedback combined with psychotherapy may improve relieve constipation patients’ clinical symptoms, anxiety/depression state and sleep quality. The treatment is durable, safe, and easy to implement, so it is suitable for widely used.

Study Objectives: This study aimed to evaluate the effect of weighted chain blankets on insomnia and sleep-related daytime symptoms for patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, and attention deficit hyperactivity disorder. Methods: One hundred twenty patients were randomized (1:1) to either a weighted metal chain blanket or a light plastic chain blanket for 4 weeks. The outcome was evaluated using the Insomnia Severity Index as primary outcome measure and day and night diaries, Fatigue Symptom Inventory, and Hospital Anxiety and Depression Scale as secondary outcome measures. Sleep and daytime activity levels were evaluated by wrist actigraphy. Results: At 4 weeks, there was a significant advantage in Insomnia Severity Index ratings of the weighted blanket intervention over the light blanket ( P < .001) with a large effect size (Cohen’s d 1.90). The intervention by the weighted blanket resulted in a significantly better sleep-maintenance, a higher daytime activity level, and reduced daytime symptoms of fatigue, depression, and anxiety. No serious adverse events occurred. During a 12-month open follow-up phase of the study, participants continuing to use weighted blankets maintained the effect on sleep, while patients switching from a light to a weighted blanket experienced an effect on Insomnia Severity Index ratings similar to that of participants using the weighted blanket from the beginning. Conclusions: Weighted chain blankets are an effective and safe intervention for insomnia in patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, or attention deficit hyperactivity disorder, also improving daytime symptoms and levels of activity. Clinical Trial Registration: Registry: ClinicalTrials.gov ; Name: Controlled Study of Chain Blanket for Insomnia; URL: https://clinicaltrials.gov/ct2/show/NCT03546036 ; Identifier: NCT03546036. Citation: Ekholm B, Spulber S, Adler M. A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders. J Clin Sleep Med . 2020;16(9):1567–1577.

Background/aim Social anxiety disorder (SAD) is a common and disabling psychiatric disorder. It is generally treated with medication and psychotherapy such as cognitive-behavioral therapy (CBT). Due to the involvement of cortical and subcortical areas in the pathophysiology of SAD, non-invasive brain stimulation techniques such as transcranial Direct Current Stimulation (tDCS) are potential adjunctive treatment options for SAD. This study aims to assess comparable efficacy of CBT, intensified tDCS, and combined CBT/tDCS on clinical symptoms and quality of life of patients with SAD and comorbid depression. Methods In this randomized controlled trial, 37 adults with SAD and comorbid depressive disorder were assigned into three groups: (1) CBT + active tDCS ( n  = 13), (2) active tDCS alone ( n  = 12), and (3) CBT + sham tDCS ( n  = 12). SAD symptoms, depressive states, quality of life and trait worry were assessed with the Liebowitz Social Anxiety Scale, Beck’s Depression Inventory, QOL questionnaire (WHOQOL-BREF), and the Penn State Worry Questionnaire respectively. The active tDCS was an intensified stimulation protocol (20 min, twice-daily sessions with 20 min intervals, 5 consecutive days) and was applied over the left dorsolateral prefrontal cortex (F3) and medial prefrontal cortex (Fpz). The CBT was provided individually based on the exposure technique at 12–20 sessions, twice a week. All clinical measures were assessed at baseline, after the intervention, and at 3-month follow-up. Results SAD symptoms significantly decreased after intervention and follow-up in all groups, with no significant differences between them. However, CBT + tDCS resulted in a numerically larger symptom reduction, significantly exceeding CBT + sham tDCS on the fear scale. Depressive states and trait worry significantly improved in all groups post-intervention and at the 3-month follow-up, with no between-group differences. Quality of life (total scores, physical, and psychological domains) significantly improved after the and at the 3-month follow-up only in the CBT + tDCS and tDCS-alone groups with no between-group differences. Conclusion Psychotherapeutic interventions​ with CBT, intensified tDCS targeting the prefrontal cortex, and the combined CBT-tDCS are effective for alleviating primary and secondary clinical symptoms in individuals with SAD. The combined CBT-tDCS intervention showed superior efficacy in reducing the primary symptoms of SAD. Trial registration ID IRCT20220421054607N1, registration date: 19/05/2022, available at: https://irct.behdasht.gov.ir/trial/63119 .

Depression and problematic alcohol use represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this is associated with increased harm and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective; however, there remains a significant gap between those in need of treatment and those receiving it. The increased availability of eHealth programs presents a unique opportunity to treat these conditions. This study aimed to evaluate the feasibility and preliminary efficacy of an automated Web-based self-help intervention (DEAL Project) in treating co-occurring depressive symptoms and problematic alcohol use in young people. Young people (aged 18 to 25 years) with moderate depression symptoms and drinking at hazardous levels (recruited largely via social media) were randomly allocated to the DEAL Project (n=60) or a Web-based attention-control condition (HealthWatch; n=44). The trial consisted of a 4-week intervention phase with follow-up assessment at posttreatment and at 3 and 6 months postbaseline. The primary outcomes were change in depression severity according to the Patient Health Questionnaire-9 as well as quantity and frequency of alcohol use (TOT-AL). The DEAL Project was associated with statistically significant improvement in depression symptom severity (d=0.71) and reductions in alcohol use quantity (d=0.99) and frequency (d=0.76) in the short term compared to the control group. At 6-month follow-up, the improvements in the intervention group were maintained; however, the differences between the intervention and control groups were no longer statistically significant, such that between-group effects were in the small to moderate range at 6 months (depression symptoms: d=0.39; alcohol quantity: d=-0.09; alcohol frequency: d=0.24). Overall, the DEAL Project was associated with more rapid improvement in both depression symptoms and alcohol use outcomes in young people with these co-occurring conditions relative to an attention-control condition. However, long-term outcomes are less clear. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000033741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363461 (Archived by WebCite at http://www.webcitation.org/6fpsLEGOy).

Abstract Study Objective: To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. Design: A blinded, randomized split-plot experimental study. Setting: Two urban academic clinical centers. Participants: 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Interventions: Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Measurements and Results: Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Conclusions: Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH’s sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of CBT-I.

Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting. We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 (95% CI: -0.59, -0.40) for depression, -0.43 (95% CI: -0.51, -0.35) for PTS, -0.42 (95% CI: -0.58, -0.27) for functional impairment, -0.48 (95% CI: -0.61, -0.34) for anxiety, -0.24 (95% CI: -0.34, -0.15) for aggression, and -0.03 (95% CI: -0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention. CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs. ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors' Summary.