scholarly journals Effectiveness of a Multicomponent Treatment based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients with Fibromyalgia (FIBROWALK study): A Randomized Controlled Trial.

2020 ◽  
Author(s):  
Mayte Serrat ◽  
Juan P. Sanabria-Mazo ◽  
Míriam Almirall ◽  
Marta Musté ◽  
Albert Feliu Soler ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Physical Function ◽  
Functional Impairment ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Number Needed To Treat ◽  
Therapeutic Exercise ◽  
Cognitive Behavioural ◽  
Neuroscience Education

Methods. A randomised controlled trial (RCT) was carried out to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioural therapy and mindfulness, in addition to treatment as usual (TAU), compared to TAU only in patients with fibromyalgia (FM). The multicomponent treatment (2h weekly sessions) was delivered in groups of 20 participants. TAU was mainly based on pharmacotherapy. We collected data on functional impairment (the Revised Fibromyalgia Impact Questionnaire [FIQR], as primary outcome), pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at 6 and 9 months. An intention to treat approach was used to analyse between-group differences. We also analysed baseline differences between responders (> 20% FIQR reduction) and non-responders and computed the number needed to treat (NNT). Results. A total of 272 patients with FM were randomly assigned to either the multicomponent treatment (n = 135) or TAU (n = 137). Significant between-group differences (p < .001) with a large effect size (Cohen’s d > .80) were found for functional impairment, pain, kinesiophobia, and physical function, whilst differences with a moderate size effect (Cohen’s d > 0.50 and < 0.80) were found for fatigue, anxiety, and depressive symptoms. Non-responders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI 1.7 - 2.3).Conclusions. Our results indicate that, when compared to TAU, the multicomponent treatment was effective for improving FM-related symptoms. Nevertheless, we must temper our findings in light of some methodological limitations in the study design.Impact statement●This is the first RCT showing positive effects on a wide range of clinical outcomes of a multicomponent treatment that integrates pain neuroscience education for patients with fibromyalgia.●This work reports promising results and it might be the first step towards a paradigm shift in the management of fibromyalgia.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

scholarly journals Outcome of Psychoanalytic and Cognitive-Behavioural Long-Term Therapy with Chronically Depressed Patients: A Controlled Trial with Preferential and Randomized Allocation

2018 ◽  
Vol 64 (1) ◽  
pp. 47-58 ◽  
Author(s):  
Marianne Leuzinger-Bohleber ◽  
Martin Hautzinger ◽  
Georg Fiedler ◽  
Wolfram Keller ◽  
Ulrich Bahrke ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Multilevel Models ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Effect Sizes ◽  
Term Therapy ◽  
Depressed Patients ◽  
Cognitive Behavioural ◽  
Remission Rates

Objective: For chronic depression, the effectiveness of brief psychotherapy has been limited. This study is the first comparing the effectiveness of long-term cognitive-behavioural therapy (CBT) and long-term psychoanalytic therapy (PAT) of chronically depressed patients and the effects of preferential or randomized allocation. Methods: A total of 252 adults met the inclusion criteria (aged 21-60 years, major depression, dysthymia, double depression for at least 24 months, Quick Inventory of Depressive Symptoms [QIDS] >9, Beck Depression Inventory II [BDI] >17, informed consent, not meeting exclusion criteria). Main outcome measures were depression self-rating (BDI) and rating (clinician-rated QIDS [QIDS-C]) by independent, treatment-blinded clinicians. Full remission rates (BDI ≤12, QIDS-C ≤5) were calculated. An independent center for data management and biostatistics analyzed the treatment effects and differences using linear mixed models (multilevel models and hierarchical models). Results: The average BDI declined from 32.1 points by 12.1 points over the first year and 17.2 points over 3 years. BDI overall mean effect sizes increased from d = 1.17 after 1 year to d = 1.83 after 3 years. BDI remission rates increased from 34% after 1 year to 45% after 3 years. QIDS-C overall effect sizes increased from d = 1.56 to d = 2.08, and remission rates rose from 39% after 1 year to 61% after 3 years. We found no significant differences between PAT and CBT or between preferential and randomized allocation. Conclusions: Psychoanalytic as well as cognitive-behavioural long-term treatments lead to significant and sustained improvements of depressive symptoms of chronically depressed patients exceeding effect sizes of other international outcome studies.

scholarly journals Chat- and internet-based cognitive–behavioural therapy in treatment of adolescent depression: randomised controlled trial

BJPsych Open ◽  
2018 ◽  
Vol 4 (4) ◽  
pp. 199-207 ◽  
Author(s):  
Naira Topooco ◽  
Matilda Berg ◽  
Sofie Johansson ◽  
Lina Liljethörn ◽  
Ella Radvogin ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Cognitive Behavioural Therapy ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Access To Treatment ◽  
For Profit ◽  
Symptoms Of Depression ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDepression is a major contributor to the burden of disease in the adolescent population. Internet-based interventions can increase access to treatment.AimsTo evaluate the efficacy of internet-based cognitive–behavioural therapy (iCBT), including therapist chat communication, in treatment of adolescent depression.MethodSeventy adolescents, 15–19 years of age and presenting with depressive symptoms, were randomised to iCBT or attention control. The primary outcome was the Beck Depression Inventory II (BDI-II).ResultsSignificant reductions in depressive symptoms were found, favouring iCBT over the control condition (F(1,67) = 6.18, P < 0.05). The between-group effect size was Cohen's d = 0.71 (95% CI 0.22–1.19). A significantly higher proportion of iCBT participants (42.4%) than controls (13.5%) showed a 50% decrease in BDI-II score post-treatment (P < 0.01). The improvement for the iCBT group was maintained at 6 months.ConclusionsThe intervention appears to effectively reduce symptoms of depression in adolescents and may be helpful in overcoming barriers to care among young people.Declaration of interestN.T. and G.A. designed the programme. N.T. authored the treatment material. The web platform used for treatment is owned by Linköping University and run on a non-for-profit basis. None of the authors receives any income from the programme.

scholarly journals Cognitive–behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial

2017 ◽  
Vol 21 (12) ◽  
pp. 1-94 ◽  
Author(s):  
Ian M Goodyer ◽  
Shirley Reynolds ◽  
Barbara Barrett ◽  
Sarah Byford ◽  
Bernadka Dubicka ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Major Depression ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Depression Symptoms ◽  
Psychological Treatments ◽  
Treatment Groups ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundAlthough there are effective psychological treatments for unipolar major depression in adolescents, whether or not one or more of the available therapies maintain reduced depressive symptoms 1 year after the end of treatment is not known. This is a non-trivial issue because maintaining lowered depressive symptoms below a clinical threshold level reduces the risk for diagnostic relapse into the adult years.ObjectiveTo determine whether or not either of two specialist psychological treatments, cognitive–behavioural therapy (CBT) or short-term psychoanalytic psychotherapy (STPP), is more effective than a reference brief psychosocial intervention (BPI) in maintaining reduction of depression symptoms in the year after treatment.DesignObserver-blind, parallel-group, pragmatic superiority randomised controlled trial.SettingA total of 15 outpatient NHS clinics in the UK from East Anglia, north-west England and North London.ParticipantsAdolescents aged 11–17 years withDiagnostic and Statistical Manual of Mental Disorders-Fourth Edition major depression including those with suicidality, depressive psychosis and conduct disorder. Patients were randomised using stochastic minimisation controlling for age, sex and self-reported depression sum score; 470 patients were randomised and 465 were included in the analyses.InterventionsIn total, 154 adolescents received CBT, 156 received STPP and 155 received BPI. The trial lasted 86 weeks and study treatments were delivered in the first 36 weeks, with 52 weeks of follow-up.Main outcome measuresMean sum score on self-reported depressive symptoms (primary outcome) at final study assessment (nominally 86 weeks, at least 52 weeks after end of treatment). Secondary measures were change in mean sum scores on self-reported anxiety symptoms and researcher-rated Health of the Nation scales for children and adolescents measuring psychosocial function. Following baseline assessment, there were a further five planned follow-up reassessments at nominal time points of 6, 12, 52 and 86 weeks post randomisation.ResultsThere were non-inferiority effects of CBT compared with STPP [treatment effect by final follow-up = –0.578, 95% confidence interval (CI) –2.948 to 4.104;p = 0.748]. There were no superiority effects for the two specialist treatments (CBT + STPP) compared with BPI (treatment effect by final follow-up = –1.898, 95% CI –4.922 to 1.126;p = 0.219). At final assessment there was no significant difference in the mean depressive symptom score between treatment groups. There was an average 49–52% reduction in depression symptoms by the end of the study. There were no differences in total costs or quality-of-life scores between treatment groups and prescribing a selective serotonin reuptake inhibitor (SSRI) during treatment or follow-up did not differ between the therapy arms and, therefore, did not mediate the outcome.ConclusionsThe three psychological treatments differed markedly in theoretical and clinical approach and are associated with a similar degree of clinical improvement, cost-effectiveness and subsequent maintenance of lowered depressive symptoms. Both STPP and BPI offer an additional patient treatment choice, alongside CBT, for depressed adolescents attending specialist Child and Adolescent Mental Health Services. Further research should focus on psychological mechanisms that are associated with treatment response, the maintenance of positive effects, determinants of non-response and whether or not brief psychotherapies are of use in primary care and community settings.LimitationsNeither reason for SSRI prescribing or monitoring of medication compliance was controlled for over the course of the study, and the economic results were limited by missing data.Trial registrationCurrent Controlled Trials ISRCTN83033550.FundingThis project was funded by the National Institute for Heath Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 12. See the National Institute for Heath Research Journals Library website for further project information. Funding was also provided by the Department of Health. The funders had no role in the study design, patient recruitment, data collection, analysis or writing of the study, any aspect pertinent to the study or the decision to submit toThe Lancet.

scholarly journals A controlled trial of Cognitive Behavioural Therapy-based strategies for insomnia among in-school adolescents in southern Nigeria

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Diseyei R. Egbegi ◽  
Tolulope Bella-Awusah ◽  
Olayinka Omigbodun ◽  
Cornelius Ani
Keyword(s):  
Depressive Symptoms ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sleep Hygiene ◽  
Behavioural Therapy ◽  
Public And Private ◽  
Cognitive Behavioural ◽  
Southern Nigeria ◽  
Sleep Difficulties

Abstract Background Sleep difficulties are highly prevalent among adolescents, and are associated with significant impairments. The effectiveness and acceptability of Cognitive Behavioural Therapy-based (CBT-based) treatment for insomnia in adolescents is established for High Income Countries, but unknown for African settings. Thus, the aim of this study was to assess the effect of CBT-based intervention among in-school adolescents with sleep difficulties in Southern Nigeria. Methods This was a pilot controlled trial involving 50 adolescents with highest ranked scores on the Insomnia Severity Index (ISI) recruited from four schools (two government and two privately owned). Balloting was used to assign two schools (public and private) with 25 participants to the intervention group, and the other two schools (public and private) with 25 participants as waiting-list controls. The two groups were dyad-matched for baseline ISI scores, gender, and type of school to reduce baseline differences. The treatment group received weekly group-based manualised CBT-based intervention over 5 weeks. Primary outcome was ISI score at 6th week. Secondary outcomes were sleep onset latency (SOL), Total sleep duration (TSD), depressive symptoms, sleep hygiene, and knowledge about sleep. Results Participants were aged 13–17 years (M = 14.9, SD = 1.16) and consisted of 18 males and 32 females. Controlling for baseline scores, the intervention group showed significantly lower post-intervention insomnia scores compared with the control group {F (1, 34) = 1.10, p = 0.0001, (ηp2 = 0.59}, shorter SOL {F (1, 33) = 1.41, p = 0.0001, ηp2 = 0.39}, longer TSD {F (1, 33) = 1.03, p = 0.0001, ηp2 = 0.47}, lower depressive symptoms {F (1, 31) = 1.32, p = 0.002 (ηp2 = 0.34}, higher knowledge of sleep {F (1, 34) = 1.02, p = 0.001, ηp2 = 0.36}, but no significant change in sleep hygiene {F (1, 32) = 1.08, p = 0.08, ηp2 = 0.15}. All participants in the intervention group rated the programme as good or excellent. Conclusion This pilot CBT-based intervention for adolescents with insomnia was feasible, well received and showed promising efficacy in this setting. Larger controlled trials are recommended to establish the generalisability of these findings in this region. Trial registration Pan African Clinical Trial Registry (Registration Number PACTR202001710494962)

scholarly journals Caregivers’ effects of augmented cognitive-behavioural therapy for post-stroke depressive symptoms in patients: secondary analyses to a randomized controlled trial

2019 ◽  
Vol 33 (6) ◽  
pp. 1056-1065 ◽  
Author(s):  
Joyce A Kootker ◽  
Caroline M van Heugten ◽  
Bart Kral ◽  
Sascha MC Rasquin ◽  
Alexander C Geurts ◽  
...  
Keyword(s):  
Mental Health ◽  
Depressive Symptoms ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Cognitive Behavioural ◽  
Secondary Analyses

Objective: To investigate the concomitant effects of two patient-directed interventions for post-stroke depressive symptoms on caregivers’ well-being. Design: Secondary analyses of the results of a randomized controlled trial. Subjects: Fifty caregivers of stroke patients receiving outpatient rehabilitation. Interventions: Stroke patients and their caregivers were randomly allocated to either cognitive-behavioural therapy augmented with movement or occupational therapy ( n = 23) or computerized cognitive training ( n = 27) to alleviate depressive symptoms in patients. Main measures: Emotional burden (Involvement Evaluation Questionnaire), practical burden (Caregiver Strain Index), mental health (General Health Questionnaire) and emotional complaints (Hospital Anxiety and Depression Scale). Results: Caregivers of patients who received cognitive-behavioural therapy reported significantly higher mental health levels (mean difference (MD) = 1.78, 95% confidence interval (CI) = 0.43–3.13, P = 0.01) and less worrying about patients’ well-being (MD = 1.9, 95% CI = 0.56–3.24, P < 0.01). In addition, there were positive time effects on the Involvement Evaluation Questionnaire for Brain Injury, particularly the subscales Worrying, Supervision and Tension. Conclusion: The results suggest that augmented cognitive-behavioural therapy aimed at improving patients’ emotional, behavioural and social functioning positively affects some aspects of caregivers’ well-being.

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