Short group psychoeducation followed by daily electronic self-monitoring in the long-term treatment of bipolar disorders: a multicenter, rater-blind, randomized controlled trial

Abstract Background Despite various pharmacological and psychological treatment interventions, bipolar disorders rank among the leading causes of global disease burden. Group psychoeducation has been demonstrated an effective add-on to pharmacotherapy, but it may be difficult to implement in practice depending on the clinical setting and available human resources. Methods Multicenter, rater-blind, randomized controlled trial to investigate the efficacy of a new intervention program consisting of an initial 6-week psychoeducation protocol plus a subsequent structured daily computer-based self-charting program (ChronoRecord) over 54 weeks in remitted patients with bipolar disorders. The control condition included non-structured group sessions followed by daily computer-based self-reports (unstructured like a diary). Both groups received treatment-as-usual. Results Over 2 years, 41 mood episodes occurred in the experimental group (n = 39) compared to 27 in the control group (n = 34), without reaching statistical significance. Time to recurrence did not significantly differ between the experimental and control group (25% relapsed after 112 and 273 days, respectively). There were no significant group-by-time interactions in mood symptoms, quality of life, self-efficacy expectations or perceived involvement in care. Conclusions Six weekly psychoeducational group sessions followed by daily self-monitoring via ChronoRecord for 54 weeks may not be superior to non-structured group meetings followed by unstructured self-reporting. Other psychotherapeutic interventions may be needed to optimize the treatment of patients with bipolar disorders, especially for those at later disease stages. Trial registration Retrospectively registered at German Clinical Trials Register on May 24, 2019; DRKS00017319

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Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/27162 ◽

2021 ◽

Vol 23 (9) ◽

pp. e27162

Author(s):

Philipp Schwaninger ◽

Corina Berli ◽

Urte Scholz ◽

Janina Lüscher

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

The Self ◽

Daily Smoking ◽

Control Group ◽

Smoking Abstinence ◽

Self Monitoring ◽

Randomized Controlled

Background Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7723-z

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Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial (Preprint)

10.2196/preprints.27162 ◽

2021 ◽

Author(s):

Philipp Schwaninger ◽

Corina Berli ◽

Urte Scholz ◽

Janina Lüscher

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

The Self ◽

Daily Smoking ◽

Control Group ◽

Smoking Abstinence ◽

Self Monitoring ◽

Randomized Controlled

BACKGROUND Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (<i>buddy</i>) in daily life. OBJECTIVE The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. METHODS A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. RESULTS A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. CONCLUSIONS Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. CLINICALTRIAL ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7723-z

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Efficacy of an Internet-based, individually tailored smoking cessation program: A randomized-controlled trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x16655476 ◽

2016 ◽

Vol 23 (5) ◽

pp. 521-528 ◽

Cited By ~ 6

Author(s):

Céline Mavrot ◽

Iris Stucki ◽

Fritz Sager ◽

Jean-François Etter

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Self Efficacy ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Motivation To Quit ◽

Computer Based ◽

E Mail ◽

Tailored Program

Introduction Self-help computer-based programs are easily accessible and cost-effective interventions with a great recruitment potential. However, each program is different and results of meta-analyses may not apply to each new program; therefore, evaluations of new programs are warranted. The aim of this study was to assess the marginal efficacy of a computer-based, individually tailored program (the Coach) over and above the use of a comprehensive Internet smoking cessation website. Methods A two-group randomized controlled trial was conducted. The control group only accessed the website, whereas the intervention group received the Coach in addition. Follow-up was conducted by e-mail after three and six months (self-administrated questionnaires). Of 1120 participants, 579 (51.7%) responded after three months and 436 (38.9%) after six months. The primary outcome was self-reported smoking abstinence over four weeks. Results Counting dropouts as smokers, there were no statistically significant differences between intervention and control groups in smoking cessation rates after three months (20.2% vs. 17.5%, p = 0.25, odds ratio (OR) = 1.20) and six months (17% vs. 15.5%, p = 0.52, OR = 1.12). Excluding dropouts from the analysis, there were statistically significant differences after three months (42% vs. 31.6%, p = 0.01, OR = 1.57), but not after six months (46.1% vs. 37.8%, p = 0.081, OR = 1.41). The program also significantly increased motivation to quit after three months and self-efficacy after three and six months. Discussion An individually tailored program delivered via the Internet and by e-mail in addition to a smoking cessation website did not significantly increase smoking cessation rates, but it increased motivation to quit and self-efficacy.

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Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression

European Psychiatry ◽

10.1016/j.eurpsy.2015.09.004 ◽

2015 ◽

Vol 30 (8) ◽

pp. 900-906 ◽

Cited By ~ 16

Author(s):

C.J.P. Simons ◽

J.A. Hartmann ◽

I. Kramer ◽

C. Menne-Lothmann ◽

P. Höhn ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Group Treatment ◽

Antidepressant Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Self Monitoring ◽

Randomized Controlled ◽

Experimental Group ◽

Reliable Increase

AbstractBackgroundInterventions based on the experience sampling method (ESM) are ideally suited to provide insight into personal, contextualized affective patterns in the flow of daily life. Recently, we showed that an ESM-intervention focusing on positive affect was associated with a decrease in symptoms in patients with depression. The aim of the present study was to examine whether ESM-intervention increased patient empowerment.MethodsDepressed out-patients (n = 102) receiving psychopharmacological treatment who had participated in a randomized controlled trial with three arms: (i) an experimental group receiving six weeks of ESM self-monitoring combined with weekly feedback sessions, (ii) a pseudo-experimental group participating in six weeks of ESM self-monitoring without feedback, and (iii) a control group (treatment as usual only). Patients were recruited in the Netherlands between January 2010 and February 2012. Self-report empowerment scores were obtained pre- and post-intervention.ResultsThere was an effect of group × assessment period, indicating that the experimental (B = 7.26, P = 0.061, d = 0.44, statistically imprecise) and pseudo-experimental group (B = 11.19, P = 0.003, d = 0.76) increased more in reported empowerment compared to the control group. In the pseudo-experimental group, 29% of the participants showed a statistically reliable increase in empowerment score and 0% reliable decrease compared to 17% reliable increase and 21% reliable decrease in the control group. The experimental group showed 19% reliable increase and 4% reliable decrease.ConclusionsThese findings tentatively suggest that self-monitoring to complement standard antidepressant treatment may increase patients’ feelings of empowerment. Further research is necessary to investigate long-term empowering effects of self-monitoring in combination with person-tailored feedback.

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Patients’ Acceptability of Computer-Based Information on Hypodontia: A Randomized Controlled Trial

JDR Clinical & Translational Research ◽

10.1177/2380084418773992 ◽

2018 ◽

Vol 3 (3) ◽

pp. 246-255

Author(s):

A. Ben Gassem ◽

R. Foxton ◽

D. Bister ◽

J.T. Newton

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Care Facility ◽

Control Group ◽

Randomized Controlled ◽

Education Material ◽

Computer Based ◽

The Mean ◽

Evaluation Inventory

Objectives: To compare patients’ acceptability of a hypodontia-specific interactive computer-based education material (ICB-EM) versus a British Orthodontic Society (BOS) hypodontia leaflet. Trial Design: Two-arm parallel randomized controlled trial, 1:1 allocation ratio. Methods: The study was conducted at a specialized secondary care facility in the Greater London area. Ninety-six new hypodontia patients aged 14 y and older were randomly assigned to the control group ( n = 49) receiving the BOS leaflet or the intervention group ( n = 47) receiving the ICB-EM. The main outcome measure was patients’ evaluation of the intervention measured by the treatment evaluation inventory. Results: The analyzed sample comprised 76 participants: control group ( n = 38) and intervention group ( n = 38). The mean age of the sample was 19 y (SD = 7.24) and 20.3 y (SD = 6.9) for the control and intervention group, respectively. The intervention group was significantly more satisfied with the ICB-EM than individuals who received the BOS leaflet ( t = −3.53, P = 0.001). Conclusion: Patients preferred the computer-based information. Knowledge Transfer Statement: Patients attending dental care in the 21st century are adept in the use of computerised facilities for obtaining information. The results of the study will provide valuable evidence for clinicians on the level of acceptability of the patients toward interactive computer based health education as opposed to traditional paper leaflets.

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An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

10.31234/osf.io/8jfgc ◽

2020 ◽

Author(s):

Jojanneke A. Bastiaansen ◽

Daan Alexander Ornée ◽

Maaike Meurs ◽

Albertine Oldehinkel

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Social Functioning ◽

Controlled Trial ◽

Control Group ◽

Depression Treatment ◽

Self Monitoring ◽

Pragmatic Randomized Controlled Trial ◽

Randomized Controlled ◽

Ecological Momentary

Background Depression treatment might be enhanced by Ecological Momentary Interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice. MethodsOutpatients starting depression treatment at secondary mental health services (N = 161; MIDS-DEPRESSION = 35.9, SD = 10.7; MAGE = 32.8, SD = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period. ResultsOf the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning and empowerment. Furthermore, trajectories of the two EMI modules were very similar. ConclusionsWe did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI’s promise of effectiveness has not materialized yet.

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Acceptability and feasibility of the ‘DASH for Asthma’ intervention in a randomized controlled trial pilot study

Public Health Nutrition ◽

10.1017/s136898001500350x ◽

2015 ◽

Vol 19 (11) ◽

pp. 2049-2059 ◽

Cited By ~ 4

Author(s):

Andrea C Blonstein ◽

Nan Lv ◽

Carlos A Camargo ◽

Sandra R Wilson ◽

A Sonia Buist ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Theory ◽

Controlled Trial ◽

Self Regulation ◽

Behavioural Intervention ◽

Uncontrolled Asthma ◽

Self Monitoring ◽

Participant Engagement ◽

Randomized Controlled ◽

Group Sessions

AbstractObjective‘DASH for Asthma’ (n90) was a 6-month randomized controlled trial that demonstrated potential benefits of a DASH (Dietary Approaches to Stop Hypertension) behavioural intervention for improving diet quality and asthma control by comparing intervention to usual care in adults with uncontrolled asthma. The present study examined acceptability and feasibility of the intervention from the perspective of intervention participants and lifestyle coaches.DesignGrounded in Social Cognitive Theory, the 3-month intensive stage, including three individual and eight group sessions, focused on diet modifications and behavioural self-regulation. The 3-month maintenance stage contained telephone consultations. Participants and lifestyle coaches completed surveys including 5-point Likert scales and open-ended questions. We analysed data using descriptive and inductive content analyses.SubjectsForty-six intervention participants (survey response rate was 65–72 %) and two lifestyle coaches.ResultsParticipants and lifestyle coaches were highly satisfied (all mean ratings >4) with individual and group sessions. Participants identified mastery of knowledge and skills (awareness, goal setting, self-monitoring, problem solving), social learning (class members sharing experiences and ideas) and good coaching skills (reflective listening, empathy, motivational counselling) as important contributors to self-efficacy and programme satisfaction. Participants also valued personalized feedback received in individual sessions. Lifestyle coaches viewed participant engagement as a facilitator to effective sessions. Finally, participants and lifestyle coaches identified food tasting as beneficial for observational learning and facilitation of participant engagement. High class attendance and self-monitoring rate also reflected the high engagement among participants.ConclusionsThe DASH behavioural intervention was feasible and highly acceptable to participants with uncontrolled asthma and lifestyle coaches.

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An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

Psychological Medicine ◽

10.1017/s0033291720004845 ◽

2020 ◽

pp. 1-10

Author(s):

Jojanneke A. Bastiaansen ◽

Daan A. Ornée ◽

Maaike Meurs ◽

Albertine J. Oldehinkel

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Social Functioning ◽

Controlled Trial ◽

Control Group ◽

Depression Treatment ◽

Self Monitoring ◽

Pragmatic Randomized Controlled Trial ◽

Randomized Controlled ◽

Ecological Momentary

Abstract Background Depression treatment might be enhanced by ecological momentary interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice. Methods Outpatients starting depression treatment at secondary mental health services (N = 161; MIDS−DEPRESSION = 35.9, s.d. = 10.7; MAGE = 32.8, s.d. = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period. Results Of the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning, and empowerment. Furthermore, the trajectories of the two EMI modules were very similar. Conclusions We did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI's promise of effectiveness has not materialized yet.

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Potentials and barriers of using digital tools for collecting daily measurements in multiple sclerosis research

Digital Health ◽

10.1177/20552076211055552 ◽

2021 ◽

Vol 7 ◽

pp. 205520762110555

Author(s):

Westergaard Katrine ◽

Signe Baattrup Ritzel ◽

Krogh Caroline ◽

Lynning Marie ◽

Bergien Sofie Olsgaard ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Outcome Measurement ◽

Controlled Trial ◽

The Self ◽

Digital Tools ◽

Control Group ◽

Unintended Effects ◽

Self Monitoring ◽

Randomized Controlled

Objective Digital tools offer new ways of collecting outcome data in intervention research. Little is known about the potentials and barriers of using such tools for outcome measurement in multiple sclerosis trials. This study aimed to examine reporting adherence and barriers experienced by people with multiple sclerosis in an intervention study using three different digital tools for outcome measurement. Methods This was a mixed-methods study conducted in the context of a randomized controlled trial. Data collected during the randomized controlled trial were analysed to assess reporting adherence. Twenty-three semi-structured, in-depth interviews were conducted to investigate randomized controlled trial participants’ experiences. Results Reporting adherence was high for all three measurement tools, but lower in the control group. Four main barriers were defined: (1) the self-monitoring aspect and repeated tests imbedded in the digital tools affected participants’ behavior during the randomized controlled trial. (2) Self-monitoring caused some participants to worry more about their health. (3) Passively collected data did not always correspond with participants’ own experiences, which caused them to question the validity of the collected data. (4) Daily reporting using different digital tools placed a significant burden on participants. Conclusion The study indicates a high reporting adherence using digital tools among people with multiple sclerosis. However, future studies should carefully consider the overall burden imposed on participants when taking this approach. Measures should be taken to avoid the potential unintended effects of the self-monitoring and gamification aspects of using digital tools. These measures could include passive monitoring, reducing the frequency of reporting and blinding participants to their own data.

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Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial

Nursing Research and Practice ◽

10.1155/2015/159205 ◽

2015 ◽

Vol 2015 ◽

pp. 1-14 ◽

Cited By ~ 7

Author(s):

Heidi Ruotsalainen ◽

Helvi Kyngäs ◽

Tuija Tammelin ◽

Hanna Heikkinen ◽

Maria Kääriäinen

Keyword(s):

Physical Activity ◽

Body Mass Index ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Control Groups ◽

Self Monitoring ◽

Randomized Controlled ◽

Lifestyle Counselling ◽

And Control

Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13–16-year-old adolescents.Methods. Three-arm randomized controlled trial. Participants (n=46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act,n=15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb,n=16) and a third group served as the control group (n=15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used.Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p=0.021), but there was no interaction between time and group.Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifierNCT02295761(2014-11-17).

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