Two Novel Cognitive Behavioral Therapy-Based Mobile Apps for Agoraphobia: Randomized Controlled Trial.
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SUBMITTER: Christoforou M
PROVIDER: S-EPMC5722980 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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).
| S-EPMC5405291 | biostudies-literature
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.
| S-EPMC6485299 | biostudies-literature
Project description:Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT (N = 24), TFT (N = 24) or a wait-list condition (WLC) (N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT (n = 12) or TFT (n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT (N = 12 + 24 = 36) to TFT (N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample's t-test, the Fisher's exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC (p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT (p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919.
| S-EPMC5477545 | biostudies-literature
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.
| S-EPMC7175183 | biostudies-literature
Project description:Despite the negative effects of depression in Parkinson's disease, there is currently no evidence-based standard of care. The purpose of this study was to examine the efficacy of individually administered cognitive-behavioral therapy (CBT), relative to clinical monitoring (with no new treatment), for depression in this medical population.Eighty depressed (based on DSM-IV criteria) patients with Parkinson's disease participated in a randomized, controlled trial of CBT relative to clinical monitoring (1:1 ratio) in an academic medical center from April 2007 to July 2010. All patients continued to maintain stable medication regimens under the care of their personal physicians. The 17-item Hamilton Depression Rating Scale (HAM-D) total score was the primary outcome. CBT was modified to meet the unique needs of the Parkinson's disease population and provided for 10 weeks. Assessments were completed by blind raters at baseline and 5 (midpoint), 10 (end of treatment), and 14 weeks (follow-up evaluation) postrandomization.The CBT group reported greater reductions in depression (change in HAM-D score) than the clinical monitoring group. At week 10, the mean HAM-D score change was 7.35 for CBT relative to 0.05 for clinical monitoring. CBT was also superior to clinical monitoring on several secondary outcomes (i.e., Beck Depression Inventory scores, anxiety, quality of life, coping, Parkinson's disease symptom ratings). There were more treatment responders in the CBT group than the clinical monitoring group (56% versus 8%, respectively).CBT may be a viable approach for the treatment of depression in Parkinson's disease. Further research is needed to replicate and extend these findings.
| S-EPMC3186855 | biostudies-literature
Project description:Posttraumatic 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.To 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.Randomized 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.Couples 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).Clinician-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.PTSD 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.Among 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.clinicaltrials.gov Identifier: NCT00669981.
| S-EPMC4404628 | biostudies-literature
Project description:Prior studies of hypochondriasis demonstrated benefits for pharmacotherapy and for cognitive-behavioral therapy (CBT). This study examined whether joint treatment offers additional benefit.Patients with DSM-IV hypochondriasis (N=195) were randomly assigned to one of four treatments-placebo, CBT, fluoxetine, or joint treatment with both fluoxetine and CBT. Evaluations assessed hypochondriasis, other psychopathology, adverse events, functional status, and quality of life. The primary analysis assessed outcome at week 24 among the intent-to-treat sample, with responders defined as having a 25% or greater improvement over baseline on both the Whiteley Index and a modified version of the Yale-Brown Obsessive Compulsive Scale for hypochondriasis (H-YBOCS-M). The Cochran-Armitage trend test assessed the hypothesized pattern of response: joint treatment > CBT or fluoxetine treatment > placebo treatment.The predicted pattern of response was statistically significant, as shown by the following responder rates: joint treatment group, 47.2%; single active treatment group, 41.8%; and placebo group, 29.6%. Responder rates for each active treatment were not significantly different from the rate for placebo. Secondary analyses of the Whiteley Index as a continuous measure revealed that, compared with placebo, fluoxetine (but not CBT) was significantly more effective at week 24 in reducing hypochondriasis and had a significantly faster rate of improvement over 24 weeks. Fluoxetine also resulted in significantly less anxiety and better quality of life than placebo. Dropout rates did not differ between groups, and treatment-emergent adverse events were evenly distributed.This study supports the safety, tolerance, and efficacy of fluoxetine for hypochondriasis. Joint treatment provided a small incremental benefit. Because approximately 50% of patients did not respond to the study treatments, new or more intensive approaches are needed.
| S-EPMC5957509 | biostudies-literature
Project description:Dental anxiety affects approximately 9% of children and is associated with poor oral health, pain, and psychosocial problems. The objective of this study was to investigate the efficacy of cognitive behavioral therapy (CBT) for children with dental anxiety in specialist pediatric dentistry. The study used a parallel-group superiority randomized controlled trial design. The primary outcome measure was the behavioral avoidance test; assessors were blind to treatment allocation. Participants were 8 boys and 22 girls 7 to 18 y old (mean ± SD, 10 ± 3.1). Children fulfilling the diagnostic criteria for dental anxiety were randomized to CBT (n = 13) or treatment as usual (n = 17), such as various sedation methods. Psychologists provided 10 h of CBT based on a treatment manual. Treatments were conducted in a naturalistic real-world clinical setting. Assessments were conducted before the treatment, 3 mo after the start of treatment, and at 1-y follow-up. The analyses of the primary outcome measure by repeated-measures analysis of variance and independent t test showed that children receiving CBT made superior, statistically significant improvements at follow-up (16.8 ± 2.4) compared with treatment as usual (11.4 ± 3.1, P < 0.01). A large between-group effect size (Cohen's d = 1.9) was found. Following treatment, 73% of those in the CBT group managed all stages of the dental procedures included in the behavioral avoidance test compared with 13% in the treatment-as-usual group. Furthermore, 91% in the CBT group compared with 25% in the treatment-as-usual group no longer met the diagnostic criteria for dental anxiety at the 1-y follow-up according to the secondary outcome measure. Measures of dental anxiety and self-efficacy showed larger improvements in the CBT group compared with controls. We conclude that CBT is an efficacious treatment for children and adolescents with dental anxiety and should be made accessible in pediatric dentistry (ClinicalTrials.gov: NCT01798355). Knowledge transfer statement: The results of this study can be used by decision makers and clinicians when planning to implement evidence-based treatment in pediatric dentistry and give children and adolescents access to methods for treating dental anxiety. The results can also be used by parents of children with dental anxiety when asking dentists to cooperate with psychologists using cognitive behavioral therapy.
| S-EPMC5772454 | biostudies-literature
Project description:BACKGROUND:Web-based interventions present a potentially cost-effective approach to supporting self-management for cancer patients; however, further evidence for acceptability and effectiveness is needed. OBJECTIVE:The goal of our research was to assess the effectiveness of an individualized Web-based cognitive behavioral therapy (CBT) intervention on improving psychological and quality of life outcomes in cancer patients with elevated psychological distress. METHODS:A total of 163 distressed cancer patients (111 female, 68.1%) were recruited through the Queensland Cancer Registry and the Cancer Council Queensland Cancer Helpline and randomly assigned to either a Web-based tailored CBT intervention (CancerCope) (79/163) or a static patient education website (84/163). At baseline and 8-week follow-up we assessed primary outcomes of psychological and cancer-specific distress and unmet psychological supportive care needs and secondary outcomes of positive adjustment and quality of life. RESULTS:Intention-to-treat analyses showed no evidence of a statistically significant intervention effect on primary or secondary outcomes. However, per-protocol analyses found a greater decrease for the CancerCope group in psychological distress (P=.04), cancer-specific distress (P=.02), and unmet psychological care needs (P=.03) from baseline to 8 weeks compared with the patient education group. Younger patients were more likely to complete the CancerCope intervention. CONCLUSIONS:This online CBT intervention was associated with greater decreases in distress for those patients who more closely adhered to the program. Given the low costs and high accessibility of this intervention approach, even if only effective for subgroups of patients, the potential impact may be substantial. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12613001026718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364768&isReview=true (Archived by WebCite at http://www.webcitation.org/6uPvpcovl).
| S-EPMC5812983 | biostudies-literature
Project description:BackgroundPremenstrual syndrome (PMS) is a common problem of women of reproductive age, affecting various aspects of their lives. However, limited studies have investigated the effect of internet-based cognitive-behavioral therapy (ICBT) on PMS. Therefore, we aimed to assess whether ICBT can reduce symptom severity of women with PMS and improve their quality of life during the perimenstrual and late follicular phases of menstrual cycle.MethodsThe study included 92 university students aged 18-35 years who had moderate to severe PMS. The participants were allocated into two groups of 46 using block randomization. The intervention group underwent ICBT for two menstrual cycles, while the control group received no intervention. Before and after the intervention, all participants filled the Daily Record of Severity of Problems (DRSP) for two menstrual cycles and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) on days 1-2 and 11-13 of the menstrual cycle. Data were analyzed using univariate general linear models.ResultsFour students in the intervention group were lost to follow-up. Following the intervention, the mean score of total PMS symptoms was significantly lower in the intervention group than in the control group (10.4 vs. 20.2, adjusted difference: - 9.9 [95% CI - 13.3 to - 6.6]), and the score of perimenstrual quality of life was significantly higher (64.2 vs. 50.3, 14.1 [8.5 to 19.8]). However, there was no significant intergroup difference in the late follicular quality of life (68.3 vs. 67.3, 1.9 [- 4.4 to 8.1]).ConclusionsThe ICBT could reduce the symptom severity of women suffering from PMS while improving their perimenstrual quality of life. However, it had no significant effect on the late follicular quality of life. Therefore, this intervention can be used for women with PMS. Trial registration The Iranian Registry of Clinical Trials, Identifier: IRCT20100414003706N34, Registered prospectively on 19 June 2019, https://www.irct.ir/trial/38394 .
| S-EPMC8741531 | biostudies-literature