Effects of a psychosocial intervention at one-year follow-up in a PREDIMED-plus sample with obesity and metabolic syndrome

AbstractThis study examines if overweight/obesity are related to higher impulsivity, food addiction and depressive symptoms, and if these variables could be modified after 1 year of a multimodal intervention (diet, physical activity, psychosocial support). 342 adults (55–75 years) with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus Cognition study were randomized to the intervention or to the control group (lifestyle recommendations). Cognitive and psychopathological assessments were performed at baseline and after 1-year follow-up. At baseline, higher impulsivity was linked to higher food addiction and depressive symptoms, but not to body mass index (BMI). Food addiction not only predicted higher BMI and depressive symptoms, but also achieved a mediational role between impulsivity and BMI/depressive symptoms. After 1 year, patients in both groups reported significant decreases in BMI, food addiction and impulsivity. BMI reduction and impulsivity improvements were higher in the intervention group. Higher BMI decrease was achieved in individuals with lower impulsivity. Higher scores in food addiction were also related to greater post-treatment impulsivity. To conclude, overweight/obesity are related to higher impulsivity, food addiction and depressive symptoms in mid/old age individuals with MetS. Our results also highlight the modifiable nature of the studied variables and the interest of promoting multimodal interventions within this population.

Download Full-text

Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial

Journal of Diabetes Research ◽

10.1155/2015/798460 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 6

Author(s):

Angela O’Dea ◽

Marie Tierney ◽

Brian E. McGuire ◽

John Newell ◽

Liam G. Glynn ◽

...

Keyword(s):

Type 2 Diabetes ◽

Mixed Methods ◽

Gestational Diabetes ◽

Lifestyle Intervention ◽

Intervention Group ◽

Outcome Variable ◽

Control Group ◽

One Year

Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM).Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n=24) or wait control (n=26) and postintervention qualitative interviews with participants.Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up.Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance.Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

Download Full-text

Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

10.2196/preprints.34028 ◽

2021 ◽

Author(s):

Krämer Rico

Keyword(s):

Depressive Symptoms ◽

Depressive Disorders ◽

Depressive Symptomatology ◽

Controlled Trial ◽

Intervention Group ◽

Online Intervention ◽

Self Report ◽

Secondary Outcome ◽

Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

Download Full-text

Effectiveness of a School-Based Indicated Early Intervention Program for Māori and Pacific Adolescents

Journal of Pacific Rim Psychology ◽

10.1375/prp.5.1.40 ◽

2011 ◽

Vol 5 (1) ◽

pp. 40-50 ◽

Cited By ~ 10

Author(s):

Barbara Woods ◽

Paul E. Jose

Keyword(s):

Depressive Symptoms ◽

Early Intervention ◽

Intervention Program ◽

Intervention Group ◽

Control Group ◽

Program Participation ◽

Early Intervention Program ◽

School Based ◽

Final Sample ◽

One Year

AbstractThis study set out to determine the efficacy of a school-based early intervention program (the Kiwi ACE program) with Māori and Pacific adolescents experiencing depressive symptoms. A large group (N = 419) of Māori and Pacific students (average age 14 years) was screened for depressive symptoms and, from a pool of students scoring greater than 63 on the Children's Depression Inventory (CDI), 56 students were randomly assigned to either an intervention or control group. After attrition, the final sample constituted 24 young people after one year. The intervention comprised eight 90-minute sessions conducted in school time. Students were taught to more fully understand the relationships between thinking, feeling and behaviour, to challenge beliefs and to solve interpersonal problems. At immediate posttest (p = .045) and at one-year follow-up (p < .001) a significant effect for condition was obtained: the intervention group reported lower depressive symptoms. Efficacy of the intervention was supported by qualitative data obtained from focus groups. Further controlled trials on a larger scale are recommended to establish the durability and generalisability of the effects of program participation.

Download Full-text

Evaluation of a school-based cognitive–behavioral depression prevention program

Scandinavian Journal of Public Health ◽

10.1177/1403494817746537 ◽

2017 ◽

Vol 47 (2) ◽

pp. 182-189 ◽

Cited By ~ 5

Author(s):

Pernilla Garmy ◽

Eva K. Clausson ◽

Agneta Berg ◽

Katarina Steen Carlsson ◽

Ulf Jakobsson

Keyword(s):

Depressive Symptoms ◽

Outcome Measures ◽

Prevention Program ◽

Intervention Group ◽

Cost Utility ◽

Control Group ◽

Depression Prevention ◽

Self Rated Health ◽

School Based

Aim: The aim of this study was to investigate the feasibility and cost-utility of a school-based cognitive–behavioral (CB) depression prevention program. Methods: A quasi-experimental trial with an intervention group and a control group, with follow-up measurements obtained at three and 12 months after baseline, was conducted. The setting was six Swedish municipalities. The participants were students in grade 8 (median age: 14). A total of 462 students (79% girls) were allocated to the school-based CB prevention program, and 486 students (46% girls) were allocated to the control group. The school-based CB prevention program, Depression in Swedish Adolescents (DISA), was presented by school health service staff and teachers once per week for 10 weeks. Results: The main outcome measures were self-reported depressive symptoms and self-rated health; the secondary outcome measures were adherence and cost-utility. The intervention group decreased their self-reported depressive symptoms (as measured by the Center for Epidemiological Studies Depression Scale) and improved their self-rated health (as measured by the visual analog scale) at the 12-month follow-up more than the control group ( p < .05). Conclusions: Given the challenges of conducting a study in a complex, everyday school setting with baseline differences between the intervention and control group, it is difficult to make accurate interpretations of the effectiveness of the intervention. However, with these limitations in mind, the results indicate that the DISA program is a feasible school-based prevention program.

Download Full-text

Abstract 12604: Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Study

Circulation ◽

10.1161/circ.142.suppl_3.12604 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Renata de Barros e Silva ◽

Denise Hachul ◽

PEDRO GABRIEL M DE BARROS E SILVA ◽

Mauricio I Scanavacca

Keyword(s):

Quality Of Life ◽

Vasovagal Syncope ◽

Intervention Group ◽

Tilt Test ◽

Control Group ◽

Sf 36 ◽

Significant Difference ◽

One Year

Introduction: Vasovagal syncope presents a benign prognosis in terms of survival but is associated with significant impairment on quality of life (QoL). Poor emotional status contributes to the recurrence of events. Hypothesis: Among patients with recurrent vasovagal syncope, weekly sessions of psychotherapy may improve QoL and reduce the number of events during one year of follow-up. Methods: A randomized controlled trial was conducted including 10 patients with recurrent vasovagal syncope and positive tilt test. Cardiac disease and ongoing psychotherapeutic interventions were the main exclusion criteria. After randomization, half of the eligible patients underwent weekly sessions of psychotherapy during 12 months, while the control group was followed according to the standard of care, without psychotherapy. QoL by SF-36 and recurrence of syncope and pre-syncope were compared between the 2 groups and also in each group pre and post randomization. Results: All patients had a positive tilt test (80% with mixed vasovagal response), 70% were female and the mean age was 47.4 ± 11.1 years. The average rate of events before inclusion was 4.1 (± 3.4) syncopes/year and 1.26 (± 0.5) episodes of presyncope/week. The groups were well balanced at baseline and all patients completed the planned follow-up of one year. In the assessment of QoL by SF-36, comparing before and one year after randomization, there was no statistically significant difference in the control group (49.9 ± 9.8 vs 46.9 ± 3.4, P = 0.20) but there was a significant improvement in the intervention group (44.9 ± 11.9 vs 68.8 ± 7.8, P < 0.01). Comparing both groups at 12 months, patients that underwent sessions of psychotherapy had better QoL (68.8 ± 7.8 vs 46.9 ± 3.4, P < 0.01). Regarding the recurrence of syncope events, there was no significant change in the control group; however, in the intervention group there was a significant reduction in the rate of presyncope episodes per month (5.6 ± 2.1 vs 1.7 ± 0.9; P = 0.02) and also a significant reduction in the rate of syncope per year (4.6 ± 3.3 vs 1.0 ± 0.7; P = 0.04). Conclusions: In a randomized clinical trial, patients with recurrent vasovagal syncope undergoing regular psychotherapeutic intervention had less recurrence of events and improved quality of life in one year.

Download Full-text

Prevention of Depressive Symptoms and Promotion of Well-being in Adolescents: A Randomized Controlled Trial of the Smile Program

Anales de Psicología ◽

10.6018/analesps.35.2.342591 ◽

2019 ◽

Vol 35 (2) ◽

pp. 300-313

Author(s):

Óscar Sánchez-Hernández ◽

Francisco X. Méndez ◽

Manuel Ato ◽

Judy Garber

Keyword(s):

Depressive Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Behavioral Approach ◽

Control Group ◽

Post Intervention ◽

Post Test ◽

Intervention Condition

This study addressed the development and evaluation of the Smile Program whose main objective was the prevention of depression and the promotion of well-being in adolescents. The program is based on interventions that have been shown to be efficacious (a cognitive-behavioral approach). Participants were 89 adolescents (mean age = 13.88 years; SD = 0.95) recruited from a sample of 1212 students from seven schools. Results showed a significant reduction in self-reported depressive symptoms in the intervention group (n= 51) as compared to youth in the control group (n= 38). Based on parents’ report (n=56), youth in the intervention group had significantly better self-esteem at post-test as compared to youth in the control group. At four months post intervention, youth in the intervention group had higher psychological well-being than those in the control group; at the 8-month follow-up, youth in the intervention condition reported better family self-concept.

Download Full-text

Mamma Mia – A randomized controlled trial of an internet-based intervention for perinatal depression

Psychological Medicine ◽

10.1017/s0033291718002544 ◽

2018 ◽

Vol 49 (11) ◽

pp. 1850-1858 ◽

Cited By ~ 11

Author(s):

Silje Marie Haga ◽

Filip Drozd ◽

Carina Lisøy ◽

Tore Wentzel-Larsen ◽

Kari Slinning

Keyword(s):

Depressive Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Control Group ◽

Group Data ◽

Perinatal Depressive Symptoms ◽

Group 2 ◽

And Control

AbstractBackgroundStudies suggest that 10–15% of perinatal women experience depressive symptoms. Due to the risks, problems with detection, and barriers to treatment, effective universal preventive interventions are needed. The aim of this study was to assess the effectiveness of an automated internet intervention (‘Mamma Mia’) on perinatal depressive symptoms. Mamma Mia is tailored specifically to the perinatal phase and targets risk and protective factors for perinatal depressive symptoms.MethodsA total of 1342 pregnant women were randomized to an intervention (‘Mamma Mia’) and control group. Data were collected at gestational week (gw) 21–25, gw37, 6 weeks after birth, and 3 and 6 months after birth. We investigated whether (1) the intervention group displayed lower levels of depressive symptoms compared with the control group, (2) the effect of Mamma Mia changed over time, (3) the effect on depressive symptoms was moderated by baseline depressive symptoms, previous depression, and parity, and (4) this moderation changed by time. Finally, we examined if the prevalence of mothers with possible depression [i.e. Edinburgh Postnatal Depression Scale (EPDS)-score ⩾10] differed between the intervention and control group.ResultsParticipants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) = 7.03, p = 0.008]. There were indications that the effect of Mamma Mia was moderated by EPDS score at baseline. The prevalence of women with EPDS-score ⩾10 was lower in the Mamma Mia group at all follow-up measurements.ConclusionsThe study demonstrated the effects of the automated web-based universal intervention Mamma Mia on perinatal depressive symptoms.

Download Full-text

One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients’ Depression: A Randomized, Single-Blinded, Controlled Study

The Scientific World JOURNAL ◽

10.1155/2015/373149 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 2

Author(s):

Kai-Jo Chiang ◽

Tsai-Hui Chen ◽

Hsiu-Tsu Hsieh ◽

Jui-Chen Tsai ◽

Keng-Liang Ou ◽

...

Keyword(s):

Group Therapy ◽

Rating Scale ◽

Intervention Group ◽

Automatic Thoughts ◽

Controlled Study ◽

Control Group ◽

Cognitive Behavioral Group Therapy ◽

One Year

The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention(P<0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended(P<0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

Download Full-text

Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomized controlled trial

Cell Transplantation ◽

10.1177/0963689719883813 ◽

2019 ◽

Vol 28 (12) ◽

pp. 1632-1640

Author(s):

Esteban J. Estrada ◽

José Luis Decima ◽

Guillermo Bortman ◽

Javier Roberti ◽

Elida Beatriz Romero ◽

...

Keyword(s):

Standard Treatment ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

C Peptide ◽

Randomized Controlled ◽

Insulin Requirements ◽

One Year

The objective of this study was to compare standard treatment versus the combination of intrapancreatic autologous stem cell (ASC) infusion and hyperbaric oxygen treatment (HBOT) before and after ASC in the metabolic control of patients with type 2 diabetes mellitus (T2DM). This study was a prospective, randomized controlled trial. The combined intervention consisted of 10 sessions of HBOT before the intrapancreatic infusion of ASC and 10 sessions afterwards. ASCs were infused into the main arterial supply of the pancreas to maximize the presence of the stem cells where the therapeutic effect is most desired. A total of 23 patients were included (control group = 10, intervention group = 13). Age, gender, diabetes duration, number of medications taken, body weight and height, and insulin requirements were recorded at baseline and every three months. Also, body mass index, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR) were measured every three months for one year. HbA1c was significantly lower in the intervention group compared with control throughout follow-up. Overall, 77% of patients in the intervention group and 30% of patients in the control group demonstrated a decrease of HbA1c at 180 days (compared with baseline) of at least 1 unit. Glucose levels were significantly lower in the intervention group at all timepoints during follow-up. C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively, p = 0.0021. CPGR was higher in the intervention group at all controls during follow-up. The requirement for insulin was significantly lower in the intervention group at 90, 180, 270, and 365 days. Combined therapy of intrapancreatic ASC infusion and HBOT showed increased metabolic control and reduced insulin requirements in patients with T2DM compared with standard treatment.

Download Full-text

Comparing audiometric parameters between crushed and intact cartilage tympanoplasty: a double-blinded, randomised, controlled trial study

The Journal of Laryngology & Otology ◽

10.1017/s0022215120002327 ◽

2020 ◽

pp. 1-5

Author(s):

A Tajdini ◽

N Hatami ◽

B Rahmaty ◽

A Kouhi ◽

S Dabiri ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Hearing Results ◽

Cartilage Tympanoplasty ◽

One Year ◽

Randomised Controlled ◽

Double Blinded

Abstract Objective To investigate hearing and the take rate of crushed cartilage grafts in tympanoplasty. Methods In this double-blinded, randomised, controlled trial, 46 patients with tympanic membrane perforation were enrolled. A conchal cartilage graft was used for reconstruction in both intervention and control groups. In the intervention group, crushed cartilage was used. The success rate and hearing results were ascertained every four months over a one-year follow-up period. Results A total of 36 patients – 20 in the intervention group and 16 in the control group – completed one year of follow up. There were no statistically significant differences between the two groups in mean air–bone gap, bone conduction threshold, speech discrimination score or speech reception threshold. Conclusion The reduction in living cells after crushed cartilage tympanoplasty may decrease the rigidity and the volume of the graft, but may not necessarily improve the hearing results.

Download Full-text