Dataset Information

Two Novel Cognitive Behavioral Therapy-Based Mobile Apps for Agoraphobia: Randomized Controlled Trial.

ABSTRACT:

Background

Despite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions.

Objective

The objective of our study was to evaluate for the first time the effectiveness of a self-guided mobile-based intervention primarily targeting agoraphobic symptoms, with respect to a generic mobile app targeting anxiety.

Methods

A Web-based randomized controlled trial (RCT) compared a novel mobile app designed to target agoraphobia (called Agoraphobia Free) with a mobile app designed to help with symptoms of anxiety in general (called Stress Free). Both interventions were based on established cognitive behavioral principles. We recruited participants (N=170) who self-identified as having agoraphobia and assessed them online at baseline, midpoint, and end point (posttreatment) over a period of 12 weeks. The primary outcome was symptom severity measured by the Panic and Agoraphobia Scale.

Results

Both groups had statistically significant improvements in symptom severity over time (difference -5.97, 95% CI -8.49 to -3.44, P<.001 for Agoraphobia Free and -6.35, 95% CI -8.82 to -3.87, P<.001 for Stress Free), but there were no significant between-group differences on the primary outcome (difference 0.38, 95% CI -1.96 to 3.20, P=.64).

Conclusions

This is, to our knowledge, the first RCT to provide evidence that people who identify as having agoraphobia may equally benefit from a diagnosis-specific and a transdiagnostic mobile-based intervention. We also discuss clinical and research implications for the development and dissemination of mobile mental health apps.

Trial registration

International Standard Randomized Controlled Trial Number (ISRCTN): 98453199; http://www.isrctn.com /ISRCTN98453199 (Archived by WebCite at http://www.webcitation.org/6uR5vsdZw).

SUBMITTER: Christoforou M

PROVIDER: S-EPMC5722980 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Publications

Two Novel Cognitive Behavioral Therapy-Based Mobile Apps for Agoraphobia: Randomized Controlled Trial.

Christoforou Marina M Sáez Fonseca José Andrés JA Tsakanikos Elias E

Journal of medical Internet research 20171124 11

<h4>Background</h4>Despite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions.<h4>Objective</h4>The objective of our study was to evaluate for the first time the effectiveness of a ...[more]

PMID: 29175809

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Project description:BackgroundThis study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia.ObjectiveThe objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial.MethodsWe recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant's progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition.ResultsThe results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=-0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up.ConclusionsThis study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens.Trial registrationNetherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4).

Project description:ObjectiveTo evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy.MethodsRandomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial intervention that addresses sleep-related behaviors and cognitions) or a control intervention consisting of imagery exercises that paired patient-identified distressing nighttime experiences with patient-identified neutral images. Participants were eligible if they met diagnostic criteria for insomnia disorder and were between 18 and 32 weeks of gestation. Patients were ineligible if they met diagnostic criteria for major psychiatric disorders, including depression, or were receiving nonstudy treatments that could affect sleep (or both). The primary outcome was the Insomnia Severity Index score, a validated brief questionnaire, with scores between 14 and 21 representing clinically meaningful insomnia of moderate severity, scores higher than 21 representing severe insomnia, and scores less than 8 representing no insomnia. Secondary outcomes included remission of insomnia (Insomnia Severity Index score less than 8), objectively measured and self-reported time awake (ie, total wake time), and the Edinburgh Postnatal Depression Scale score. All outcomes were measured weekly. Analysis included 48 participants who did not complete treatment. We estimated that 184 women would be required to have 80% power, with a two-tailed test, to detect a moderate Cohen's d effect size (.5) with α=.05.ResultsBetween May 2013 and April 2017, 194 pregnant women were randomized and 149 completed treatment; 179 with available baseline data (92%) were ultimately analyzed, 89 in the cognitive therapy group and 90 in the control group. Women assigned to cognitive behavioral therapy for insomnia experienced significantly greater reductions in insomnia severity (scores decreased from 15.4±4.3 to 8.0±5.2 in the cognitive behavioral therapy group vs from 15.9±4.4 to 11.2±4.9 in the control therapy group [P<.001, d=0.5]). Remission of insomnia (to an Insomnia Severity Index score less than 8) disorder was attained by 64% of women in the cognitive behavioral therapy for insomnia group vs 52% in the control group. Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control therapy (P<.001). Cognitive behavioral therapy for insomnia led to significantly greater reduction in self-reported but not objective total wake time and a small but significantly greater decline in Edinburgh Postnatal Depression Scale scores vs the control group.ConclusionCognitive behavioral therapy for insomnia is an effective nonpharmacologic treatment for insomnia during pregnancy.Clinical trial registrationClinicalTrials.gov, NCT01846585.

Project description:BACKGROUND:Evidence shows that computerized self-help interventions are effective for reducing symptoms of depression. One such intervention, SPARX, is a gamified mobile computerized cognitive behavioral therapy (cCBT) developed for adolescents in New Zealand, which was shown to be as effective as usual care for young people with mild-to-moderate symptoms of depression. However, gamified cCBT has not yet been tested in Japan. OBJECTIVE:This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild-to-moderate depressive symptoms. METHODS:In this 7-week, multicenter, stratified, parallel-group, superiority randomized trial, participants will be allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is a fully automated program, which will be delivered to the mobile phone or tablet device of the participants. SPARX is designed as an interactive fantasy game to guide the user through seven modules that teach key CBT strategies. All participants will be recruited from universities via advertisements on online bulletin boards, the campus newspaper, and posters. Participants in the treatment condition will use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using Patient Health Questionnaires-9) measured at baseline and weekly: once after the 7-week intervention and once at a 1-month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life, measured by the Satisfaction With Life Scale; positive and negative moods, measured by the Profile of Mood States Second Edition; social functioning, measured by the EuroQol Instrument; rumination, measured by the Ruminative Responses Scale; and coping, measured by the Brief Coping Orientation to Problem Experienced Inventory. RESULTS:This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019. CONCLUSIONS:Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX with Japanese university students. TRIAL REGISTRATION:Japan Primary Registries Network UMIN000034354; https://tinyurl.com/uu7xd77. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15164.

Project description:Assertiveness training has been an essential component in cognitive-behavioral therapy (CBT), for example, in the treatment of social anxiety and in dialectical behavioral therapy. However, the assertiveness construct has garnered little attention in recent clinical research. The objective of this study was to investigate the efficacy of an eight-week transdiagnostic stand-alone internet-based CBT intervention specifically aimed at increasing levels of assertive behavior. Following inclusion, we randomized N = 210 participants into three groups: therapist-guided self-help, unguided self-help, and a wait-list control condition. After a one-year follow-up, we employed a linear mixed model to estimate the effects at both post-test and follow-up for the primary outcome measures of assertiveness, Adaptive and Aggressive Assertiveness Scales, the Rathus Assertiveness Schedule, and secondary outcome measures of anxiety, depression, and general well-being. We also assessed reliable clinical change. Compared to the wait list at the post-treatment, estimated between-group effect sizes on self-rated adaptive assertiveness were statistically equivalent for the two treatment groups both at the post and at the one-year follow-up time points, ranging from ES = 0.95 to 1.73, with reliable clinical recovery proportions from 19 % to 36 %. The increase in aggressive assertiveness ranged from ES = 0.62 to 0.90 compared to the wait-list condition at post. For social anxiety symptoms, the effects compared to the wait list at post-treatment ranged from ES = 0.67 to 0.93, with a reliable clinical recovery rate from 16 % to 26 %. For self-assessed well-being, the effects compared to the wait list at post ranged from ES = 0.70 to 1.05. No effects were observed for generalized anxiety, although within-group evidence was found for a medium effect on depression one year after treatment. Overall, the two treatment conditions produced similar effects. In general, participation increased healthy assertive expressions regardless of treatment condition, all the while reducing self-assessed social anxiety and, over time, possibly also depression. Participation also improved general well-being. The findings demonstrate that the assertiveness construct can be a suitable target for intervention, with reductions of both psychiatric symptoms and non-syndromal problems in daily life. The study was preregistered at ClinicalTrials.gov (NCT04240249).

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Project description:ContextPosttraumatic stress disorder (PTSD) is a prevalent condition associated with intimate relationship problems, and intimate relationship factors have been shown to affect individual PTSD treatment outcomes.ObjectiveTo compare cognitive-behavioral conjoint therapy for PTSD (a manualized couple therapy delivered to patients with PTSD and their significant others to simultaneously treat PTSD symptoms and enhance relationship satisfaction) with a wait-list condition.Design, setting, and participantsRandomized controlled trial of heterosexual and same-sex couples (n = 40 couples; n = 80 individuals) in which one partner met criteria for PTSD according to the Clinician-Administered PTSD Scale, conducted from 2008 to 2012 in a Department of Veterans Affairs outpatient hospital setting in Boston, Massachusetts, and a university-based research center in Toronto, Ontario, Canada. Symptoms of PTSD, comorbid conditions, and relationship satisfaction were collected by blinded assessors at baseline, at mid treatment (median, 8.00 weeks [range, 1.71-20.43 weeks] after baseline), and at posttreatment (median, 15.86 weeks [range, 7.14-38.57 weeks] after baseline). An uncontrolled 3-month follow-up (median, 38.21 weeks [range, 28.43-50.57 weeks] after baseline) was also completed.InterventionCouples were randomly assigned to take part in the 15-session cognitive-behavioral conjoint therapy for PTSD protocol immediately (n = 20) or were placed on a wait list for the therapy (n = 20).Main outcome measuresClinician-rated PTSD symptom severity was the primary outcome and was assessed with the Clinician-Administered PTSD Scale. Intimate relationship satisfaction, assessed with the Dyadic Adjustment Scale, patient- and partner-rated PTSD symptoms, and comorbid symptoms were secondary outcomes.ResultsPTSD symptom severity (score range, 0-136) was significantly more improved in the couple therapy condition than in the wait-list condition (mean change difference, -23.21; 95% CI, -37.87 to -8.55). Similarly, patients' intimate relationship satisfaction (score range, 0-151) was significantly more improved in couple therapy than in the wait-list condition (mean change difference, 9.43; 95% CI, 0.04-18.83). The time × condition interaction effect in the multilevel model predicting PTSD symptoms (t37.5 = -3.09; P = .004) and patient-reported relationship satisfaction (t68.5 = 2.00; P = .049) revealed superiority of the couple therapy compared with the wait list. Treatment effects were maintained at 3-month follow-up.ConclusionAmong couples in which one partner was diagnosed as having PTSD, a disorder-specific couple therapy, compared with a wait list for the therapy, resulted in decreased PTSD symptom severity and patient comorbid symptom severity and increased patient relationship satisfaction.Trial registrationclinicaltrials.gov Identifier: NCT00669981.

Dataset Information

Two Novel Cognitive Behavioral Therapy-Based Mobile Apps for Agoraphobia: Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Two Novel Cognitive Behavioral Therapy-Based Mobile Apps for Agoraphobia: Randomized Controlled Trial.

Similar Datasets

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