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Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies.

ABSTRACT: BACKGROUND:There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS:The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION:To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION:Clinicalstrials.gov as NCT03159715 . Registered 19 May 2017.

SUBMITTER: Mira A

PROVIDER: S-EPMC6500058 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Project description:Traditionally, evidence-based treatments for depression have focused on negative symptoms. Different authors describe the need to include positive affect as a major target of treatment. Positive psychology aims to fill this gap. Reaching everyone in need is also important, and Internet-based interventions can help in this task. The present study is a secondary analysis derived from a randomized controlled trial aimed to test the efficacy of an Internet-based intervention for patients with depressive symptoms. This intervention consisted of an 8-module Internet-based program that combined four modules based on cognitive-behavioral therapy strategies and four modules based on positive psychology strategies. The main goal of this secondary analysis is to report the data collected after each module from the participants who completed the intervention, explore the changes throughout the intervention process, and examine the changes observed in the different variables before versus after the introduction of the positive psychology component. A total of 103 patients completed the intervention. At pre-, post-intervention, and post-module evaluations, they completed positive and negative affect, depression, and anxiety measures. Negative affect and anxiety decreased significantly during the implementation of the cognitive-behavioral therapy and positive psychology modules. However, depression and positive affect improved only after the introduction of the positive psychology modules. This is the first study to explore, throughout the intervention process (module by module), the incorporation of a positive psychology component in an Internet-based program. Results suggest that positive psychology techniques might have an impact on clinical symptomatology, and they emphasize the need to include these techniques to achieve a more profound change in positive functioning measures. Clinical Trial Registration: NCT02148354 (http://ClinicalTrials.gov/ct2/show/NCT02148354).

Project description:BackgroundInternet-based cognitive behavioral therapy (ICBT) for tinnitus is an evidence-based intervention. The components of ICBT for tinnitus have, however, not been dismantled and thus the effectiveness of the different therapeutic components is unknown. It is, furthermore, not known if heterogeneous tinnitus subgroups respond differently to ICBT.AimsThis dismantling study aimed to explore the contribution of applied relaxation within ICBT for reducing tinnitus distress and comorbidities associated with tinnitus. A secondary aim was to assess whether outcomes varied for three tinnitus subgroups, namely those with significant tinnitus severity, those with low tinnitus severity, and those with significant depression.MethodsA parallel randomized controlled trial design (n = 126) was used to compare audiologist-guided applied relaxation with the full ICBT intervention. Recruitment was online and via the intervention platform. Assessments were completed at four-time points including a 2-month follow-up period. The primary outcome was tinnitus severity as measured by the Tinnitus Functional Index. Secondary outcomes were included for anxiety, depression, insomnia, negative tinnitus cognitions, health-related quality of life, hearing disability, and hyperacusis. Treatment engagement variables including the number of logins, number of modules opened, and the number of messages sent. Both an intention-to-treat analysis and completer's only analysis were undertaken.ResultsEngagement was low which compromised results as the full intervention was undertaken by few participants. Both the ICBT and applied relaxation resulted in large reduction of tinnitus severity (within-group effect sizes d = 0.87 and 0.68, respectively for completers only analysis), which were maintained, or further improved at follow-up. These reductions in tinnitus distress were greater for the ICBT group, with a small effect size differences (between-group d = 0.15 in favor of ICBT for completers only analysis). Tinnitus distress decreased the most at post-intervention for those with significant depression at baseline. Both ICBT and applied relaxation contributed to significant reductions on most secondary outcome measures, with no group differences, except for a greater reduction of hyperacusis in the ICBT group.ConclusionDue to poor compliance partly attributed to the COVID-19 pandemic results were compromised. Further studies employing strategies to improve compliance and engagement are required. The intervention's effectiveness increased with initial level of tinnitus distress; those with the highest scores at intake experienced the most substantial changes on the outcome measures. This may suggest tailoring of interventions according to tinnitus severity. Larger samples are needed to confirm this.

Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:BackgroundSelf-guided internet-based cognitive behavioral therapies (iCBTs) for depressive symptoms may substantially increase accessibility to mental health treatment. Despite this, questions remain as to the generalizability of the research on self-guided iCBT.ObjectiveWe sought to describe the clinical entry criteria used in studies of self-guided iCBT, explore the criteria's effects on study outcomes, and compare the frequency of use of these criteria with their use in studies of face-to-face psychotherapy and antidepressant medications. We hypothesized that self-guided iCBT studies would use more stringent criteria that would bias the sample toward those with a less complex clinical profile, thus inflating treatment outcomes.MethodsWe updated a recently published meta-analysis by conducting a systematic literature search in PubMed, MEDLINE, PsycINFO, and EMBASE. We conducted a meta-regression analysis to test the effect of the different commonly used psychiatric entry criteria on the treatment-control differences. We also compared the frequency with which exclusion criteria were used in the self-guided iCBT studies versus studies of face-to-face psychotherapy and antidepressants from a recently published review.ResultsOur search yielded 5 additional studies, which we added to the 16 studies identified by Karyotaki and colleagues in 2017. Few self-guided iCBT studies excluded patients with severe depressive symptoms (6/21, 29%), but self-guided iCBT studies were more likely than antidepressant (14/170, 8.2%) studies to use this criterion. However, self-guided iCBT studies did not use this criterion more frequently than face-to-face psychotherapy studies (6/16, 38%). Beyond this, we found no evidence that self-guided iCBTs used more stringent entry criteria. Strong evidence suggested that they were actually less likely to use most entry criteria, especially exclusions on the basis of substance use or personality pathology. None of the entry criteria used had an effect on outcomes.ConclusionsA conservative interpretation of our findings is that the patient population sampled in the literature on self-guided iCBT is relatively comparable with that of studies of antidepressants or face-to-face psychotherapy. Alternatively, studies of unguided cognitive behavioral therapy may sample from a more heterogeneous and representative patient population. Until evidence emerges to suggest otherwise, the patient population sampled in self-guided iCBT studies cannot be considered as less complex than the patient population from face-to-face psychotherapy or antidepressant studies.

Project description:BackgroundPrevious randomized controlled trials (RCTs) have shown a significant intervention effect of internet-based computerized cognitive behavioral therapy (iCBT) on improving nonclinical depressive symptoms among healthy workers and community residents in a primary prevention setting. Time preference is one's relative valuation for having a reward (eg, money) at present than at a later date. Time preference may affect the effectiveness of cognitive behavioral therapy.ObjectiveThis RCT aimed to test the difference of intervention effect of an iCBT program on improving nonclinical depressive symptoms between two subgroups classified post-hoc on the basis of time preference among workers in Japan.MethodsAll workers in one corporate group (approximate n=20,000) were recruited. Participants who fulfilled the inclusion criteria were randomly allocated to either intervention or control groups. Participants in the intervention group completed 6 weekly lessons and homework assignments within the iCBT program. The Beck Depression Inventory-II (BDI-II) and Kessler's Psychological Distress Scale (K6) measures were obtained at baseline and 3-, 6-, and 12-month follow-ups. Two subgroups were defined by the median of time preference score at baseline.ResultsOnly few (835/20,000, 4.2%) workers completed the baseline survey. Of the 835 participants, 706 who fulfilled the inclusion criteria were randomly allocated to the intervention or control group. Participants who selected irrational time preference options were excluded (21 and 18 participants in the intervention and control groups, respectively). A three-way interaction (group [intervention/control] × time [baseline/follow-up] × time preference [higher/lower]) effect of iCBT was significant for BDI-II (t1147.42=2.33, P=.02) and K6 (t1254.04=2.51, P=.01) at the 3-month follow-up, with a greater effect of the iCBT in the group with higher time preference. No significant three-way interaction was found at the 6- and 12-month follow-ups.ConclusionsThe effects of the iCBT were greater for the group with higher time preference at the shorter follow-up, but it was leveled off later. Workers with higher time preference may change their cognition or behavior more quickly, but these changes may not persist.Trial registrationUMIN Clinical Trials Registry UMIN000014146; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000016466 (Archived by WebCite at http://www.webcitation.org/70o2rNk2V).

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Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies.

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