scholarly journals Evaluation of a Stepped Care Approach to Manage Depression and Diabetes Distress in Patients with Type 1 Diabetes and Type 2 Diabetes: Results of a Randomized Controlled Trial (ECCE HOMO Study)

2021 ◽  
pp. 1-16
Author(s):  
Andreas Schmitt ◽  
Bernhard Kulzer ◽  
André Reimer ◽  
Christian Herder ◽  
Michael Roden ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Well Being ◽  
Stepped Care ◽  
Diabetes Distress ◽  
Diabetes Treatment ◽  
Treatment As Usual ◽  
Sf 36 ◽  
Patients With Diabetes ◽  
Care Approach

<b><i>Introduction:</i></b> Depression is a common and serious complication of diabetes. Treatment approaches addressing the specific demands of affected patients are scarce. <b><i>Objective:</i></b> The aim of this work was to test whether a stepped care approach for patients with diabetes and depression and/or diabetes distress yields greater depression reduction than treatment-as-usual. <b><i>Methods:</i></b> Two-hundred and sixty patients with diabetes and elevated depressive symptoms (CES-D ≥16) and/or elevated diabetes distress (PAID ≥40) were randomized to stepped care for depression or diabetes treatment-as-usual. The primary outcome was the rate of meaningful depression reduction at the 12-month follow-up according to the HAMD (score &#x3c;9 or reduction by ≥50%). Secondary outcomes were changes in depression scores (HAMD/CES-D), diabetes distress (PAID), diabetes acceptance (AADQ), well-being (WHO-5), quality of life (EQ-5D/SF-36), self-care behavior (SDSCA/DSMQ), HbA<sub>1c</sub>, and biomarkers of inflammation. <b><i>Results:</i></b> One-hundred and thirty-one individuals were assigned to stepped care and 129 to treatment-as-usual. Overall, 15.4% were lost to follow-up. Meaningful depression reduction was observed in 80.2 versus 51.2% in stepped care versus treatment-as-usual (<i>p</i> &#x3c; 0.001, intention-to-treat analysis). Of the secondary measures, the HAMD (∆ –3.2, <i>p</i> &#x3c; 0.001), WHO-5 (∆ 1.5, <i>p</i> = 0.007), and AADQ (∆ –1.0, <i>p</i> = 0.008) displayed significant treatment effects, while effects on CES-D (∆ –2.3, <i>p</i> = 0.065), PAID (∆ –3.5, <i>p</i> = 0.109), and SDSCA (∆ 0.20, <i>p</i> = 0.081) were not significantly different. Both groups showed comparable changes in EQ-5D/SF-36, DSMQ, HbA<sub>1c</sub>, and biomarkers of inflammation (all <i>p</i> ≥ 0.19). <b><i>Conclusions:</i></b> The stepped care approach improved depression, well-being, and acceptance. The results support that increasing treatment intensity on demand is effective and can help provide more optimal treatment. The inclusion of diabetes-specific interventions may be beneficial for patients with diabetes and elevated depression.

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial

2021 ◽  
pp. 1-14
Author(s):  
Nina Reinholt ◽  
Morten Hvenegaard ◽  
Anne Bryde Christensen ◽  
Anita Eskildsen ◽  
Carsten Hjorthøj ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Health Services ◽  
Health Services ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Major Depressive ◽  
Outpatient Mental Health ◽  
End Of Treatment

<b><i>Introduction:</i></b> The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. <b><i>Objective:</i></b> This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. <b><i>Methods:</i></b> In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. <b><i>Results:</i></b> At end-of-treatment, WHO-5 mean scores for patients in UP (<i>n</i> = 148) were non-inferior to those of patients in dCBT (<i>n</i> = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. <b><i>Conclusions:</i></b> This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

Comparing durability of water- and land-based exercise benefits among older adults in South Korea: A randomized controlled trial with 1-year follow-up

2021 ◽  
pp. 1-11
Author(s):  
Se Jun Oh ◽  
Sang Heon Lee
Keyword(s):  
Exercise Intervention ◽  
External Rotation ◽  
Short Form ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Aquatic Exercise ◽  
Step Test ◽  
Sf 36 ◽  
Partial Weight

BACKGROUND: Aquatic exercise can improve strength, flexibility, and aerobic function while safely providing partial weight-bearing support through viscosity and buoyancy. OBJECTIVE: The aim of the present study was to compare the effects of water-based exercise with land-based exercise before and after a 10-week exercise intervention and again at one-year follow-up. METHODS: Eighty participants aged 65 years and older were randomly assigned to either a water- or a land-based 10-week exercise program. Assessment included the Senior Fitness Test (SFT), the Modified Falls-Efficacy Scale, and the 36-Item Short-Form Health Survey (SF-36). Hip and knee strength was also measured. All assessments were completed at three time points: pre- (T1), post- (T2), and at 1-year follow-up (T3). RESULTS: Significant differences were observed between the two groups on three parameters: the SFT timed up-and-go test; lower hip muscle strength in extension, adduction, and external rotation; and quality of life (QoL) measured by the SF-36 (p< 0.05). No significant differences were observed in the SFT chair stand test, dominant arm curl test, two-minute step test, chair sit-and-reach test, back scratch test, and Modified Falls-Efficacy Scale. CONCLUSION: Aquatic exercise provided greater improvement of physical health and QoL among older people than land-based exercise.

scholarly journals Brief psychotherapy in Alzheimer's disease

2005 ◽  
Vol 187 (2) ◽  
pp. 143-147 ◽  
Author(s):  
Alistair Burns ◽  
Else Guthrie ◽  
Federica Marino-Francis ◽  
Charlotte Busby ◽  
Julie Morris ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Cognitive Function ◽  
Controlled Trial ◽  
Well Being ◽  
Good Evidence ◽  
Psychotherapeutic Intervention ◽  
Interpersonal Therapy ◽  
Treatment As Usual ◽  
Affective Symptoms

BackgroundAlthough there is good evidence that interventions for carers of people with Alzheimer's disease can reduce stress, no systematic studies have investigated psychotherapeutic intervention for patients themselves. This may be important in the earlier stages of Alzheimer's disease, where insight is often preserved.AimsThe aim was to assess, in a randomised controlled trial, whether psychotherapeutic intervention could benefit cognitive function, affective symptoms and global well-being.MethodIndividuals were randomised to receive six sessions of psychodynamic interpersonal therapy or treatment as usual; cognitive function, activities of daily living, a global measure of change, and carer stress and coping were assessed prior to and after the intervention.ResultsNo improvement was found on the majority of outcome measures. There was a suggestion that therapy had improved the carers' reactions to some of the symptoms.ConclusionsThere is no evidence to support the widespread introduction of brief psychotherapeutic approaches for those with Alzheimer's disease. However, the technique was acceptable and helpful individually.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals Cognitive Behavioural Therapy for Nightmares for Patients with Persecutory Delusions (Nites): An Assessor-Blind, Pilot Randomized Controlled Trial

2019 ◽  
pp. 070674371984742 ◽  
Author(s):  
Bryony Sheaves ◽  
Emily A. Holmes ◽  
Stephanie Rek ◽  
Kathryn M. Taylor ◽  
Alecia Nickless ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Serious Adverse Events ◽  
Persecutory Delusions ◽  
Treatment As Usual ◽  
Cognitive Behavioural

Objective:Nightmares are relatively common in patients experiencing psychosis but rarely assessed or treated. Nightmares may maintain persecutory delusions by portraying fears in sensory-rich detail. We tested the potential benefits of imagery-focused cognitive behavioural therapy (CBT) for nightmares on nightmare severity and persecutory delusions.Method:This assessor-blind parallel-group pilot trial randomized 24 participants with nightmares and persecutory delusions to receive CBT for nightmares delivered over 4 weeks in addition to treatment as usual (TAU) or TAU alone. Assessments were at 0, 4 (end of treatment), and 8 weeks (follow-up). Feasibility outcomes assessed therapy uptake, techniques used, satisfaction, and attrition. The primary efficacy outcome assessed nightmare severity at week 4. Analyses were intention to treat, estimating treatment effect with 95% confidence intervals (CIs).Results:All participants offered CBT completed therapy (mean [SD], 4.8 [0.6] sessions) with high satisfaction, and 20 (83%) participants completed all assessments. Compared with TAU, CBT led to large improvements in nightmares (adjusted mean difference = −7.0; 95% CI, –12.6 to –1.3; d = –1.1) and insomnia (6.3; 95% CI, 2.6 to 10.0; d = 1.4) at week 4. Gains were maintained at follow-up. Suicidal ideation was not exacerbated by CBT but remained stable to follow-up, compared with TAU, which reduced at follow-up (6.8; 95% CI, 0.3 to 3.3; d = 0.7). CBT led to reductions in paranoia (–20.8; 95% CI, –43.2 to 1.7; d = –0.6), although CIs were wide. Three serious adverse events were deemed unrelated to participation (CBT = 2, TAU = 1).Conclusions:CBT for nightmares is feasible and may be efficacious for treating nightmares and comorbid insomnia for patients with persecutory delusions. It shows promise on paranoia but potentially not on suicidal ideation.

scholarly journals A theory-based intervention to promote medication adherence in patients with rheumatoid arthritis: A randomized controlled trial

2020 ◽  
Vol 40 (1) ◽  
pp. 101-111
Author(s):  
Shahnaz Asgari ◽  
Mahnaz Abbasi ◽  
Kyra Hamilton ◽  
Yu-Pin Chen ◽  
Mark D. Griffiths ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Action Process Approach ◽  
Treatment As Usual ◽  
Loss To Follow Up ◽  
Health Action ◽  
Action Process

Abstract Introduction/objectives Adherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important that interventions are developed to address this important health behavior issue. The aim of the present study was to design and evaluate a theory-based intervention to improve the medication adherence (primary outcome) among rheumatoid arthritis patients. Methods The study adopted a pre-registered randomized controlled trial design. Rheumatoid arthritis patients were recruited from two University teaching hospitals in Qazvin, Iran from June 2018 to May 2019 and randomly assigned to either an intervention group (n = 100) or a treatment-as-usual group (n = 100). The intervention group received a theory-based intervention designed based on the theoretical underpinnings of the health action process approach (HAPA). More specifically, action planning (making detailed plans to follow medication regimen), coping planning (constructing plans to overcome potential obstacles that may arise in medication adherence), and self-monitoring (using a calendar to record medication adherence) of the HAPA has been used for the treatment. The treatment-as-usual group received standard care. Results Data analysis was conducted based on the principle of intention to treat. Using a linear mixed-effects model (adjusted for age, sex, medication prescribed, and body mass index), the results showed improved medication adherence scores in the intervention group (loss to follow-up = 16) compared to the treatment-as-usual group (loss to follow-up = 12) at the 3-month (coefficient = 3.9; SE = 0.8) and 6-month (coefficient = 4.5; SE = 0.8) follow-up. Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study. Conclusion The results of the present study support the use of a theory-based intervention for improving medication adherence among rheumatoid arthritis patients, a group at-risk of not adhering to medication regimens. Trial registration (in Iranian Registry of Clinical Trials) irct.ir, IRCT20180108038271N1 Key Points• Theoretical underpinnings of the health action process approach are useful to improve medication adherence for RA patients.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Effectiveness and feasibility of a humor training in a routine care setting for people suffering from mental disorders

2019 ◽  
Vol 32 (3) ◽  
pp. 449-473
Author(s):  
Nektaria Tagalidou ◽  
Marlene Faschingbauer ◽  
Teresa Mussuros ◽  
Willibald Ruch ◽  
Anton-Rupert Laireiter
Keyword(s):  
Mental Disorders ◽  
Care Setting ◽  
Mental Health Center ◽  
Training Group ◽  
Well Being ◽  
Routine Care ◽  
Clinical Samples ◽  
Control Group ◽  
Treatment As Usual

AbstractThe study tested effectiveness and feasibility of a humor training for members of a community mental health center suffering from schizophrenia, personality disorders, depression, or anxiety. The training group (n=28) was compared to a treatment-as-usual control group (n=26). Outcomes were divided into primary (coping humor and cheerfulness) and secondary ones (well-being, depression, anxiety, and symptomatology), and were assessed prior to and after treatment and at a six-week follow-up. Additionally, gelotophobia was explored as a confounding variable of the training outcome. Linear mixed models showed improvements in coping humor and cheerfulness compared to the control group. However, effects did not remain stable at follow-up, and secondary outcomes were unaffected by the training. Interestingly, people with higher levels in gelotophobia tended to score worse on many outcomes before training. These differences disappeared after completion but recurred in the follow-up. Feedback indicated feasibility of the training within the institution. Summarizing the results, this is one of the first studies that tried to implement humor training in a routine care setting for people with mental disorders. Results are promising, however further research is needed to investigate humor trainings in clinical samples more profoundly.

scholarly journals Sustained Long-Term Effectiveness of an Energy Management Training Course on Employee Vitality and Purpose in Life

2019 ◽  
Vol 34 (2) ◽  
pp. 177-188 ◽  
Author(s):  
Sai Krupa Das ◽  
Shawn T. Mason ◽  
Taylor A. Vail ◽  
Caroline M. Blanchard ◽  
Meghan K. Chin ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Repeated Measures ◽  
Short Form ◽  
Depression Scale ◽  
Purpose In Life ◽  
Well Being ◽  
Sf 36

Purpose: Programs designed to sustainably improve employee well-being are urgently needed but insufficiently researched. This study evaluates the long-term effectiveness of a commercial well-being intervention in a worksite setting. Design: A pre/postintervention repeated analysis with follow-up at 6, 12, and 18 months. Setting: Office-based worksites (for-profit, nonprofit, and mixed work-type; n = 8). Participants: One hundred sixty-three employees with a mean age of 47 (11) years (57% female). Intervention: A 2.5-day group-based behavioral program emphasizing vitality and purpose in life (PiL). Measures: Rand Medical Outcomes Survey (MOS) 36-Item Short Form (SF-36) with a focus on vitality (primary outcome), Ryff PiL Scale, Center for Epidemiologic Studies Depression Scale, Profile of Mood States, Rand MOS Sleep Scale, physical activity, body weight, blood pressure, and blood measures for glucose and lipids at baseline, 6, 12, and 18 months. Analysis: General linear models with repeated measures for mean values at baseline and follow-up. Results: At 18-month follow-up, sustained improvements were observed for vitality, general health, and mental health domains of SF-36 and PiL ( P < .001 for all measures). Sleep, mood, vigor, physical activity, and blood pressure were also improved at 18 months ( P < .05 for all measures). Conclusions: An intensive 2.5-day intervention showed sustained improvement in employee quality of life, PiL, and other measures of well-being over 18 months.

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