The feasibility of low-intensity psychological therapy for depression co-occurring with autism in adults: The Autism Depression Trial (ADEPT) - a pilot randomised controlled trial.
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SUBMITTER: Russell A
PROVIDER: S-EPMC8645299 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionHigh rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression.Methods and analysisA feasibility study comprising a randomised controlled trial (RCT) and nested qualitative evaluation is under way as preparation for a definitive RCT. Participants (n=70) will be randomised to Guided Self-Help: a low-intensity psychological intervention based on behavioural activation adapted for ASD or treatment as usual. Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered. The analysis will aim to establish the rates of recruitment and retention for a larger-scale RCT as well as the most appropriate measure of depression to serve as primary outcome. The qualitative study will purposively sample up to 24 participants from each treatment group to consider the acceptability and feasibility of the intervention and the trial design.Ethics and disseminationEthical approval has been received from WALES REC 3 (IRAS project ID: 191558) and the Health Research Authority with R&D approval from Avon and Wiltshire Mental Health Partnership and Northumberland, Tyne and Wear Foundation NHS Trusts. To our knowledge, this is the first study of a low-intensity intervention for depression in adults with autism. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal publications reporting the quantitative and qualitative research findings of the study and presentations at national and international conferences.Trial registration numberISRCTN54650760; Pre-results.
| S-EPMC5736092 | biostudies-literature
Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.
| S-EPMC6486988 | biostudies-literature
Project description:To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.Pilot parallel group randomised controlled feasibility trial.Participants aged ?18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.ISRCTN17544090; Pre-results.
| S-EPMC6089263 | biostudies-other
Project description:IntroductionOne in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysisA two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women's mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and disseminationStudy results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN11513120.
| S-EPMC6701625 | biostudies-literature
Project description:Group Cognitive Behavioural Therapy (CBT) may provide a means of improving mental health among people with depression but few studies have explored its effectiveness. Our aim was to examine the feasibility and acceptability of a randomised controlled trial of a group intervention based on CBT principles for women with depression in primary care.Women aged 30 to 55 years were recruited and randomly assigned to either 12 weeks of the group intervention or usual care (control). The group intervention was based on a manual and used CBT and problem solving principles with weekly topics including raising activity levels, spotting and catching negative thoughts, problem solving and relaxation. Women were recruited from deprived areas of Bristol. The groups were run by facilitators with some experience and background in group work and one weeks training in use of the course manual. Assessments of mental health were made using measures including the PHQ-9. Follow-up was at 3 and 6 months after the intervention. Qualitative methods were used to support the design of the intervention and to help understand issues of acceptability and feasibility. Interviews were conducted with all participants at baseline and at 3 and 6 months although detailed qualitative analysis was based on a purposive sample of 20 participants at the 3 time points.Of the 86 participants assessed for eligibility, 52 were allocated to the intervention arm and 21 to the control group. The intervention was delivered according to the manual despite the limited training of the facilitators. The intervention was received favourably by participants and facilitators, with good attendance at sessions for those who engaged with the intervention. Follow up rates at 3 and 6 months for women in both the intervention and control arms were also good. The trial methodology used was appropriate and feasible.This study showed that a randomised controlled trial of group CBT for women with depression is feasible and the intervention is acceptable, and may possibly prove to be effective in a larger trial. The cost effectiveness of group CBT for depression should be explored further in a full trial.NCT00663078.
| S-EPMC3119185 | biostudies-literature
Project description:Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.
| S-EPMC8693902 | biostudies-literature
Project description:ObjectivesTo evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components.Design and settingA feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.ParticipantsConsecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.InterventionsParticipants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Main outcome measuresBlinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.ResultsAt discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported.ConclusionsBoth interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome.Trial registrationISRCTN registry 33808269.
| S-EPMC4642943 | biostudies-literature
Project description:Exercise may be effective in treating depression, but trials testing its effect in depressed women are rare.To compare the effect of exercise of preferred intensity with exercise of prescribed intensity in thirty-eight women living with depression.A Pragmatic RCT of 12 sessions of exercise at preferred intensity compared with 12 sessions at prescribed intensity. Beck Depression Inventory (BDI), Rosenberg Self Esteem Scale (RSES), General Health Questionnaire 12 (GHQ-12), heart rate (HR), Rating of Perceived Exertion Scale (RPE), Quality of Life in Depression Scale (QLDS), Multi-Dimensional Scale of Perceived Social Support (MDSPSS), SF12 Health Survey and exercise participation rates were compared between groups.Intervention participants had statistically better BDI (t = 2.638, df = 36, p = 0.006, 95% mean (SD) 26.5 (10.7), CI-20.4 to -2.7, d = 0.86), GHQ-12 (t = 3.284, df = 36, p = 0.001, mean (SD) 8.3 (3.7) 95% CI -6.5 to -1.5, d = 1.08), RSES (t = 2.045, df = 36, p = 0.024, mean (SD) 11.3 (5.8), 95% CI 0.3 -6.4, d = 0.25), QLDS (t = 1.902, df = 36, p = 0.0325, mean (SD) 15.5 (7.9), 95% CI -12.2 -0.4, d = 0.27) RPE scores (t = 1.755, df = 36, p = 0.0475, mean (SD) 9.2 (3.2), 95% CI -.5 - 5.2, d = 0.77) and attended more exercise sessions (t = 1.781, df = 36, p = 0.0415, number of sessions 8 (65%), 95% CI-0.3 -4.8, d = 0.58). SF-12, MSPSS and HR did not differ significantly between groups.Exercise of preferred intensity improves psychological, physiological and social outcomes, and exercise participation rates in women living with depression.ClinicalTrials.gov: NCT00546221.
| S-EPMC3128029 | biostudies-literature
Project description:The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Adolescents aged 12-18 with low mood/depression, (scoring ?20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).ISRCTN31219579.
| S-EPMC4216856 | biostudies-other
Project description:Exercise has been shown to be effective in treating depression, but trials testing the effect of exercise for depressed adolescents utilising mental health services are rare. The aim of this study was to determine the effectiveness of a preferred intensity exercise intervention on the depressive symptoms of adolescents with depression.We randomly assigned 87 adolescents who were receiving treatment for depression to either 12 sessions of aerobic exercise at preferred intensity alongside treatment as usual or treatment as usual only. The primary outcome was depressive symptom change using the Children's Depression Inventory 2(nd) Version (CDI-2) at post intervention. Secondary outcomes were health-related quality of life and physical activity rates. Outcomes were taken at baseline, post intervention and at six month follow up.CDI-2 score reduction did not differ significantly between groups at post-intervention (est. 95% CI -6.82, 1.68, p = 0.23). However, there was a difference in CDI-2 score reduction at six month follow-up in favour of the intervention of -4.81 (est. 95% CI -9.49, -0.12, p = 0.03). Health-related quality of life and physical activity rates did not differ significantly between groups at post-intervention and follow-up.There was no additional effect of preferred intensity exercise alongside treatment as usual on depressive reduction immediately post intervention. However, effects were observed at six months post-intervention, suggesting a delayed response. However, further trials, with larger samples are required to determine the validity of this finding.ClinicalTrials.gov NCT01474837, March 16 2011.
| S-EPMC4605143 | biostudies-literature