JustKiddo/KiddosVault huggingface dataset:
Behavioural activation versus guided self-help for depression in adults with learning disabilities: the BeatIt RCT.

Depression is the most prevalent mental health problem among people with learning disabilities. The trial investigated the clinical effectiveness and cost-effectiveness of behavioural activation for depression experienced by people with mild to moderate learning disabilities. The intervention was compared with a guided self-help intervention. A multicentre, single-blind, randomised controlled trial, with follow-up at 4, 8 and 12 months post randomisation. There was a nested qualitative study. Participants were recruited from community learning disability teams and services and from Improving Access to Psychological Therapies services in Scotland, England and Wales. Participants were aged ≥18 years, with clinically significant depression, assessed using the Diagnostic Criteria for Psychiatric Disorders for use with Adults with Learning Disabilities. Participants had to be able to give informed consent and a supporter could accompany them to therapy. BeatIt was a manualised behavioural activation intervention, adapted for people with learning disabilities and depression. StepUp was an adapted guided self-help intervention. The primary outcome measure was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD). Secondary outcomes included carer ratings of depressive symptoms and aggressiveness, self-reporting of anxiety symptoms, social support, activity and adaptive behaviour, relationships, quality of life (QoL) and life events, and resource and medication use. There were 161 participants randomised (BeatIt, n=84; StepUp, n=77). Participant retention was strong, with 141 completing the trial. Most completed therapy (BeatIt: 86%; StepUp: 82%). At baseline, 63% of BeatIt participants and 66% of StepUp participants were prescribed antidepressants. There was no statistically significant difference in GDS-LD scores between the StepUp (12.94 points) and BeatIt (11.91 points) groups at the 12-month primary outcome point. However, both groups improved during the trial. Other psychological and QoL outcomes followed a similar pattern. There were no treatment group differences, but there was improvement in both groups. There was no economic evidence suggesting that BeatIt may be more cost-effective than StepUp. However, treatment costs for both groups were approximately only 4-6.5% of the total support costs. Results of the qualitative research with participants, supporters and therapists were in concert with the quantitative findings. Both treatments were perceived as active interventions and were valued in terms of their structure, content and perceived impact. A significant limitation was the absence of a treatment-as-usual (TAU) comparison. Primary and secondary outcomes, economic data and qualitative results all clearly demonstrate that there was no evidence for BeatIt being more effective than StepUp. Comparisons against TAU are required to determine whether or not these interventions had any effect. Current Controlled Trials ISRCTN09753005.
Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial.

Psilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression. We are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25mg of psilocybin. All participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO/0206), Health Research Authority (252750) and Medicine's and Healthcare Products Regulatory Agency (CTA 14523/0284/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media. EUDRACT2018-003573-97; NCT04959253.
Additive effectiveness of contingency management on cognitive behavioural treatment for smokers with depression: Six-month abstinence and depression outcomes.

Depression and smoking co-occur at high rates and there is a lack of evidence on the efficacy of treatments specifically tailored to this population. This randomized controlled trial sought to compare the effectiveness of cognitive behavioural treatment (CBT) combined with behavioural activation (BA) and the same treatment protocol plus contingency management (CM). A sample of 120 adult smokers (70.8%: females) with severe depressive symptoms were randomly allocated to: CBT + BA (n = 60) or CBT + BA + CM (n = 60). Smoking and depression outcomes were reported at end of treatment, 1-, 2-, 3-, and 6-month follow-ups. Self-reported smoking status was biochemically verified, and depression was assessed using the Beck Depression Inventory-II. At end of treatment, the overall quit rate was 69.2% (83/120). CM showed an additive effect on CBT + BA in enhancing abstinence rates. The significant effect of group [F(1,155) = 9.55, p = .0024], time [F(4,96) = 7.93, p < .0001], and group by time interaction [F(4,96) = 6.12, p = .0002], indicated that CM is more effective for generating longer durations of abstinence beyond those of CBT+BA. All treatment conditions equally promoted sustained reductions in depression across time [F(1,111) = 0.53, p = .4665]. A greater number of days of continuous abstinence and lower depressive symptoms mutually influenced each other. Depressed smokers achieve high cessation rates without suffering negative mood changes. Quitting smoking is not detrimental and adding CM to CBT + BA enhances long-lasting abstinence rates while promoting large depression improvements.
The Effects of Dietary Improvement on Symptoms of Depression and Anxiety: A Meta-Analysis of Randomized Controlled Trials.

Poor diet can be detrimental to mental health. However, the overall evidence for the effects of dietary interventions on mood and mental well-being has yet to be assessed. We conducted a systematic review and meta-analysis examining effects of dietary interventions on symptoms of depression and anxiety. Major electronic databases were searched through March 2018 for all randomized controlled trials of dietary interventions reporting changes in symptoms of depression and/or anxiety in clinical and nonclinical populations. Random-effects meta-analyses were conducted to determine effect sizes (Hedges' g with 95% confidence intervals [CI]) for dietary interventions compared with control conditions. Potential sources of heterogeneity were explored using subgroups and meta-regression analyses. Results: Sixteen eligible randomized controlled trials (published in English) with outcome data for 45,826 participants were included; the majority of which examined samples with nonclinical depression (n = 15 studies). Nonetheless, dietary interventions significantly reduced depressive symptoms (g = 0.162, 95% CI = 0.055 to 0.269, p = 0.003). Similar effects were observed among high-quality trials (g = 0.171, 95% C.I.=0.057 to 0.286, p=0.003) and when compared with both inactive (g = 0.114, 95% C.I.=0.008 to 0.219, p=0.035) and active controls (g = 0.224, 95% C.I.= 0.052 to 0.397, p = 0.011). No effect of dietary interventions was observed for anxiety (k = 11, n = 2270, g = 0.085, 95% C.I. = -0.031 to 0.202, p=0.151). Studies with female samples observed significantly greater benefits from dietary interventions, for symptoms of both depression and anxiety. Dietary interventions hold promise as a novel intervention for reducing symptoms of depression across the population. Future research is required to determine the specific components of dietary interventions that improve mental health, explore underlying mechanisms, and establish effective schemes for delivering these interventions in clinical and public health settings. PROSPERO Online Protocol: CRD42018091256.
Efficacy of a fasting-mimicking diet in functional therapy for depression: A randomised controlled pilot trial.

This randomized controlled trial examined the efficacy of adding a fasting-mimicking diet to a structured psychotherapy protocol for treating depression. Of 20 patients with depression, 10 were randomly assigned to psychotherapy and dieting (i.e., experimental group) and the other 10 to psychotherapy only (i.e., control group). Patients in both groups received 20 individual sessions of functional therapy along with nutrition consultation. Patients in the control group were instructed to maintain their usual daily diets. Both treatments were effective in reducing depression as well as increasing self-esteem and quality of life. The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group. The study revealed initial evidence of the efficacy of combining psychotherapy with a fasting-mimicking diet to treat depression and its correlates.
Electroacupuncture and cognitive behavioural therapy for sub-syndromal depression among undergraduates: a controlled clinical trial.

Individuals with sub-syndromal depression (SSD) are at increased risk of incident depressive disorders; however, the ideal therapeutic approach to SSD remains unknown. To evaluate the effects of electroacupuncture (EA) and cognitive behavioural therapy (CBT), alone or in combination, on depressive symptoms. Undergraduate students with SSD were recruited and allocated to one of four groups based on their preferences: EA (n=6), CBT (n=10), EA+CBT (n=6), and untreated control (n=11) groups. Six weeks of treatment were provided in the first three groups. Clinical outcomes were measured using the 17-item Hamilton Depression (HAMD-17) rating scale, Center for Epidemiologic Depression (CES-D) scale, WHO Quality of Life-Brief version (WHOQOL-BREF) questionnaire, and clinical remission rate. All 33 subjects were included in an intent-to-treat analysis. Statistically significant improvements in HAMD-17, CES-D, and WHOQOL-BREF scores and a higher remission rate were found in the EA, CBT, and EA+CBT intervention groups compared with the control group (all p<0.05). No significant differences were found between the three intervention groups. HAMD-17 factor score analysis revealed that EA reduced sleep disturbance scores more than CBT or EA+CBT (p<0.05), and CBT reduced retardation scores more than EA (p<0.01). EA+CBT reduced anxiety/somatisation scores more than EA or CBT (p<0.05) and retardation scores more than EA (p<0.05). Early intervention may alleviate depressive symptoms in SSD. EA and CBT may have differential effects on certain symptoms. Combination therapy targeting both physical and psychological symptoms may represent an ideal strategy for SSD intervention. However, randomised trials with larger sample sizes are needed. ChiCTR-TRC-10000889; Results.
The effect of bright light therapy on depressive symptoms in adults with intellectual disabilities: Results of a multicentre randomized controlled trial.

Although a large number of adults with intellectual disabilities have depressive symptoms, non-pharmacological treatments are scarce. The present authors investigated whether bright light therapy (BLT) is effective in decreasing depressive symptoms compared to care as usual. This multicentre randomized controlled trial consisted of three study groups (10,000 lux BLT, dim light BLT and a no-BLT group). Participants received BLT for 30 min in the morning (14 consecutive days), additional to their regular care. Primary outcome was as follows: depressive symptoms measured with the ADAMS Depressive Mood subscale 1 week after the end of BLT (same time period in the no-BLT group). Forty-one participants were included in our trial. In both BLT groups, a significant decrease in depressive symptoms was seen. No significant differences were found between 10,000 lux BLT and no-BLT (p = .199) and no significant differences between dim light BLT and no-BLT (p = .451). A minimum amount of side effects and no adverse events were reported. In both BLT interventions, a decrease in depressive symptoms was seen. With 10,000 lux BLT, depressive symptoms decreased even below the clinical cut-off point, which makes BLT a promising intervention for clinical practice.
A systematic review and meta-analysis of randomized controlled trials of cognitive behavioral therapy for hemodialysis patients with depression.

The aim of this meta-analysis was to examine the efficacy of cognitive behavioral therapy (CBT) for hemodialysis patients with comorbid depression and to identify which other aspects, including anxiety and quality of life, can be improved through intervention. A systematic literature review was performed using multiple databases (PubMed, EMBase, PsycINFO, CENTRAL). The inclusion criteria included randomized controlled trials (RCTs) of CBT conducted in hemodialysis patients with depression. Study reporting quality was assessed with the Cochrane tool and Review Manager version 5.3 was used to obtain pooled results. Eight RCTs, with a total sample size of 540 participants, met the inclusion criteria. Compared with control groups, the CBT groups had statistically significant improvements in depression (standardized mean differences [SMD] = -0.68, 95% confidence interval [CI] (-0.94 to -0.42), P < .001), anxiety (SMD = -0.99, 95%CI (-1.99 to 0.00), P = .05) and quality of life (SMD = 0.34, 95%CI (0.13 to 0.54), P < .001). The results of this meta-analysis showed that CBT could have an effective role in reducing symptoms of depression and anxiety as well as improving quality of life in hemodialysis patients with comorbid depression.
Supporting antidepressant discontinuation: the development and optimisation of a digital intervention for patients in UK primary care using a theory, evidence and person-based approach.

We aimed to develop a digital intervention to support antidepressant discontinuation in UK primary care that is scalable, accessible, safe and feasible. In this paper, we describe the development using a theory, evidence and person-based approach. Intervention development using a theory, evidence and person-based approach. Primary Care in the South of England. Fifteen participants with a range of antidepressant experience took part in 'think aloud' interviews for intervention optimisation. Our digital intervention prototype (called 'ADvisor') was developed on the basis of a planning phase consisting of qualitative and quantitative reviews, an in-depth qualitative study, the development of guiding principles and a theory-based behavioural analysis. Our optimisation phase consisted of 'think aloud' interviews where the intervention was iteratively refined. The qualitative systematic review and in-depth qualitative study highlighted the centrality of fear of depression relapse as a key barrier to discontinuation. The quantitative systematic review showed that psychologically informed approaches such as cognitive-behavioural therapy were associated with greater rates of discontinuation than simple advice to reduce. Following a behavioural diagnosis based on the behaviour change wheel, social cognitive theory provided a theoretical basis for the intervention. The intervention was optimised on the basis of think aloud interviews, where participants suggested they like the flexibility of the system and found it reassuring. Changes were made to the tone of the material and the structure was adjusted based on this qualitative feedback. 'ADvisor' is a theory, evidence and person-based digital intervention designed to support antidepressant discontinuation. The intervention was perceived as helpful and reassuring in optimisation interviews. Trials are now needed to determine the feasibility, clinical and cost-effectiveness of this approach.
The long-term effects of psychotherapy added to pharmacotherapy on morning to evening diurnal cortisol patterns in outpatients with major depression.

Psychotherapy added to pharmacotherapy results in greater improvement in clinical outcomes than does pharmacotherapy alone. However, few studies examined how psychotherapy coupled with pharmacotherapy could produce a long-term protective effect by improving the psychobiological stress response. The researchers recruited 63 subjects with major depressive disorder (MDD) in an outpatient department of psychiatry at a general hospital. The randomly assigned subjects formed 2 groups: 29 in combined therapy (COMB) and 34 in monotherapy (MT). The COMB included 8 weekly body-mind-spirit group psychotherapy sessions added to pharmacotherapy. MT consisted of pharmacotherapy only. The outcome measures, collected at the subjects' homes, included the Beck Depression Inventory II (BDI-II), the State Trait Anxiety Inventory (STAI) and salivary cortisol on awakening, 45 min after awakening, and at 12.00, 17.00 and 21.00 h. Evaluation of outcome measures was at baseline condition, and at months 2 (end of additional psychotherapy), 5 and 8. While the decreases in symptoms of depression were similar between COMB and MT (p > 0.05), the reductions in anxiety state were greater in COMB than in MT during the 8-month follow-up (p < 0.05). A steeper diurnal cortisol pattern more likely occurred in COMB than in MT in the 3 follow-up periods (p < 0.05, p <0.001 and p < 0.01). The superior outcomes of group psychotherapy added to pharmacotherapy for MDD outpatients could relate to decreasing the anxiety state and to producing long-term impacts on positive stress endocrine outcomes seen as a steeper diurnal cortisol pattern.
Adjunctive Bright Light Therapy for Non-Seasonal Major Depressive Disorder: A Randomized Controlled Trial.

This double-blind, randomized controlled trial assessed bright light therapy (BLT) augmentation efficacy compared with placebo light in treating non-seasonal major depressive disorder. The study participants belonged to a subtropical area (24.5°-25.5°N) with extensive daylight and included outpatients who had received stable dosages and various regimens of antidepressive agents for 4 weeks before enrollment. The outcomes were the 17-item Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale, and Patient Health Questionnaire-9, which were assessed at weeks 1, 2, and 4. A total of 43 participants (mean age 45 years, ranging from 22-81) were randomized into the BLT [n = 22] and placebo light groups [n = 21]. After a 4-week administration of morning light therapy (30 min/day), depressive symptoms did not reduce significantly, which might be due to the small sample size. Nonetheless, this study had some strengths because it was conducted in warmer climates, unlike other studies, and examined diverse Asians with depression. Our findings suggest that several factors, such as poor drug response, different antidepressive regimens, duration of BLT, and daylength variability (i.e., natural daylight in the environment) may influence the utility of add-on BLT. Researchers may consider these important factors for future non-seasonal depression studies in subtropical environments.
Patterns of depressive symptom remission during the treatment of seasonal affective disorder with cognitive-behavioral therapy or light therapy.

To elucidate mechanisms related to remission in winter seasonal affective disorder (SAD), we explored the course of individual depressive symptom offset across two distinct treatment modalities that show comparable outcomes at treatment endpoint: cognitive-behavioral therapy for SAD (CBT-SAD) and light therapy (LT). One hundred seventy-seven adults with SAD in a depressive episode were randomized to 6-weeks of CBT-SAD (n = 88) or LT (n = 89). Symptoms were assessed via the 29-item Structured Interview Guide for the Hamilton Rating Scale for Depression-SAD Version (SIGH-SAD) at pretreatment and weekly during treatment. Survival analyses were conducted for the 17 SIGH-SAD items endorsed by more than 40 participants at pretreatment. Within each of the included symptoms, data from participants who endorsed the symptom at pretreatment and who had 3 or fewer weeks missing were included. For most (13/17; 76%) symptoms, CBT-SAD and LT did not differ in time to remission. However, for four symptoms (early insomnia, psychic anxiety, hypersomnia, and social withdrawal), LT led to symptom remission more quickly than CBT-SAD. Symptom remission progressed comparably across CBT-SAD and LT for most symptoms. Despite the fact that the two treatments led to similar remission rates and improvements at treatment endpoint, for early insomnia, psychic anxiety, hypersomnia, and social withdrawal, LT led to symptom remission faster than CBT-SAD. These results suggest different mechanisms and pathways to the same therapeutic end. Speedier remission of early insomnia and hypersomnia is consistent with the theory that SAD is related to a pathological circadian phase-shift that can be corrected with LT.
Chronotherapy for the rapid treatment of depression: A meta-analysis.

Chronotherapy (sleep deprivation, sleep phase shifting and/or the use of bright light) combines non-invasive and non-pharmacological interventions that may act rapidly against depressive symptoms. However, to date no meta-analysis has been conducted to examine their effectiveness. We carried out meta-analysis of 16 studies (four randomised controlled trials and 12 open-label case series) with between-subject comparisons between experimental and control conditions for RCTs and within-subject comparisons between baseline and follow-up for all studies. Overall chronotherapy was generally superior to other therapies such as psychotherapy, antidepressants, exercise or light therapy alone after 5-7 days. For RCTs, chronotherapy was favoured (Hedge's g = 0.62, 95% CI 0.23-1.01) compared to control treatments such as antidepressants and exercise. 33.0% of patients were responders after 5-7 days in the chronotherapy group and 1.5% of patients in the control condition (OR = 7.58, 95% CI 2.03-28.28). For the case series, large effect sizes were found by 5-7 days (g = 1.78, 95% CI 1.49-2.07). In the case series, 61.6% of patients were classed as responders. The number of RCTs included in this meta-analysis was small, and the potential for risk of bias could not be ascertained accurately. One specific limitation is that studies nearly all included in-patients and the results may not be generalisable to out-patients, and nearly all the subjects lacked credibility ratings before receiving treatment. Chronotherapy appears to be effective and well-tolerated in depressed patients. Nevertheless, further clinical and cost effectiveness studies are needed.
[Wake therapy for major depression].

Patients admitted with depression are highly tormented and many are suicidal. Standard treatment does not offer full effect until after several weeks. Wake therapy is a method that may reduce depressive symptoms within days. In this paper, the literature regarding wake therapy is reviewed. The response rates in wake therapy are high, but the effect is often transitory. However, recent studies indicate that wake therapy in combination with other chronotherapeutic interventions, e.g. light therapy, can produce a rapid and sustained antidepressant effect.