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A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Salamanca-Sanabria A

PROVIDER: S-EPMC7055858 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial.

Salamanca-Sanabria Alicia A Richards Derek D Timulak Ladislav L Connell Sarah S Mojica Perilla Monica M Parra-Villa Yamilena Y Castro-Camacho Leonidas L

JMIR mental health 20200131 1

<h4>Background</h4>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.<h4>Objective</h4>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 ...[more]

PMID: 32003749

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Project description:BackgroundDepression is the principal cause of disability in the world. High prevalence rates of depression in general populations and college students have been found worldwide and in various cultural groups. Low-intensity cognitive behavioural internet-delivered treatment has demonstrated efficacy in high-income-countries (HICs). However little is known of their potential for adaptation and efficacy in low and middle-income countries.MethodsStudy (1) involves the cultural adaptation of the Space from Depression cognitive-behaviour internet-delivered programme with an asynchronous support for depressive symptoms. This includes initial researcher/clinician adaptation and the integration of cultural assessment feedback of the programme by a panel of experts and users through the theoretically-based Cultural Relevance Questionnaire (CRQ). Study (2) describes the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The efficacy trial will include an active treatment group and a waiting-list control group of participants meeting eligibility criteria (mild to moderate depression symptoms). The active condition will consist of 7 weekly modules of internet-delivered cognitive behavioural therapy (iCBT) Space from Depression, with post-session feedback support. The primary outcome will be the Patient Health Questionnaire (PHQ-9). The study also involves collection of client reported significant events and client satisfaction with the internet-delivered treatment. Data will be collected at baseline and at post-treatment (week 7), and at follow-up (week 20/3 months). Analysis will be conducted on the intention-to-treat basis.DiscussionThe study seeks to establish a theoretically robust methodology for culturally adapting internet-delivered interventions for mental health disorders and to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia, with support. The study will be a first contribution to a method for culturally adapting internet-delivered interventions and also a first to examine the efficacy of such an adapted intervention in Latin America.Trial registrationClinical trials NCT03062215. Retrospectively registered 14th February 2017.

Project description:BACKGROUND:Depression is a highly prevalent mental health issue that exacts significant economic, societal, personal, and interpersonal costs. Innovative internet-delivered interventions have been designed to increase accessibility to and cost-effectiveness of treatments. These treatments have mainly targeted mild to moderate levels of depression. The increased risk associated with severe depression, particularly of suicidal ideation often results in this population being excluded from research studies. As a result, the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) in more severely depressed cohorts is less researched. OBJECTIVE:The aim of this study is to examine the effect of iCBT on symptoms of severe depression, comorbid symptoms of anxiety, and levels of work and social functioning. METHODS:Retrospective consent was provided by participants with elevated scores (>28 severe depression symptoms) on the Beck Depression Inventory (BDI-II) who accessed an iCBT intervention (Space from Depression) with support for up to 8 weeks. Data were collected at baseline, posttreatment, and 3-month follow-up on the primary outcome (BDI-II), and secondary outcomes (the Generalized Anxiety Disorder-7 and the Work and Social Adjustment Scale). RESULTS:A significant change was observed on all measures between pre- and postmeasurement and maintained at 3-month follow-up. Clinical improvement was observed for participants on the BDI-II from pre- to postmeasurement, and suicidal ideation also reduced from pre- to postmeasurement. CONCLUSIONS:Users of Space from Depression with symptoms of severe depression were found to have decreased symptoms of depression and anxiety and increased levels of work and social functioning. The intervention also demonstrated its potential to decrease suicidal ideation. Further investigation is required to determine why some individuals improve, and others do not. iCBT may have the potential to be used as an adjunct treatment for severe depression symptoms, but participants may require further treatment if they receive iCBT as a standalone intervention. Although promising, further research incorporating control groups is needed to support the utility of Space from Depression for use in or as an adjunct to treatment for severe depression.

Project description:ImportanceBlack women are at risk for insomnia disorder. Despite interest in addressing sleep health disparities, there is limited research investigating the efficacy of criterion-standard treatment (cognitive behavioral therapy for insomnia [CBT-I]) among this racial minority population.ObjectiveTo compare the efficacy of a standard version of an internet-delivered CBT-I program, a culturally tailored version, and a sleep education control at improving insomnia symptoms.Design, setting, and participantsIn this single-blind, 3-arm randomized clinical trial, participants in a national, longitudinal cohort (Black Women's Health Study [BWHS]) were recruited between October 2019 and June 2020. BWHS participants with elevated insomnia symptoms were enrolled and randomized in the current study.InterventionsParticipants were randomized to receive (1) an automated internet-delivered treatment called Sleep Healthy Using the Internet (SHUTi); (2) a stakeholder-informed, tailored version of SHUTi for Black women (SHUTi-BWHS); or (3) patient education (PE) about sleep.Main outcomes and measuresThe primary outcome was insomnia severity (Insomnia Severity Index [ISI]). Index score ranged from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms. The SHUTi-BWHS program was hypothesized to be more effective at significantly decreasing insomnia severity compared with the SHUTi program and PE.ResultsA total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years. Those randomized to receive either SHUTi or SHUTi-BWHS reported significantly greater reductions in ISI score at 6-month follow-up (SHUTi: -10.0 points; 95% CI, -11.2 to -8.7; SHUTi-BWHS: -9.3 points; 95% CI, -10.4 to -8.2) than those randomized to receive PE (-3.6 points; 95% CI, -4.5 to -2.1) (P < .001). Significantly more participants randomized to SHUTi-BWHS completed the intervention compared with those randomized to SHUTi (86 of 110 [78.2%] vs 70 of 108 [64.8%]; P = .008). Participants who completed either intervention showed greater reductions in insomnia severity compared with noncompleters (-10.4 points [95% CI, -11.4 to -9.4] vs -6.2 points [95% CI, -8.6 to -3.7]).Conclusions and relevanceIn this randomized clinical trial, both the SHUTi and SHUTi-BWHS programs decreased insomnia severity and improved sleep outcomes more than PE. The culturally tailored SHUTi-BWHS program was more effective at engaging participants with the program, as a greater proportion completed the full intervention. Program completion was associated with greater improvements in sleep.Trial registrationClinicalTrials.gov Identifier: NCT03613519.

Project description:BackgroundPatients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important.ObjectiveThis randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation.MethodsWe included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported.ResultsResults showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect.ConclusionsIn patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain.Trial registrationClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942.

Project description:ObjectivesCognitive behavioral therapy (CBT) is the most promising treatment for gambling disorder (GD) but only 21% of those with problematic gambling seek treatment. CBT over the Internet might be one way to reach a larger population. The aim of this study was to assess the effectiveness of Internet-delivered CBT with therapist guidance compared to an active control treatment.MethodsUsing a single-blinded design, 71 treatment-seeking gamblers (18-75 years) diagnosed with GD were randomized to 8 weeks of Internet-delivered CBT guided by telephone support, or 8 weeks of Internet-delivered motivational enhancement paired with motivational interviewing via telephone (IMI). The primary outcome was gambling symptoms measured at a first face-to-face assessment, baseline (treatment start), every 2 weeks, post-treatment, and 6-month follow-up. Gambling expenditures, time spent gambling, depression, anxiety, cognitive distortions, and quality of life were assessed as secondary outcomes. Analysis was performed on the full analysis sample (n = 60), with intention-to-treat sensitivity analyses (n = 69).ResultsIn the CBT group, 80% stayed in treatment until the final week, compared to 67% in IMI. Post-treatment and at 6-month follow-up, no differences were found between CBT and IMI for any outcome measure. An exploratory analysis of the total sample (n = 60) showed a significant effect of time during treatment on gambling symptoms (d, [95% CI] 0.52, [-1.15, 2.02]) and all secondary outcomes except the gambling diary (depression (0.89, [-1.07-2.65]); anxiety (0.69, [-1.20-2.38])); cognitive distortions (0.84, [-0.73-2.29]); quality of life (0.60, [-0.61-1.70])). Post-treatment, there were no clinical gambling symptoms in either group. Some deterioration was seen between post-treatment and 6-month follow-up on gambling symptoms (0.42, [-1.74-2.43]), depression (0.59, [-0.82-1.86]), and anxiety (0.30, [-0.99-1.48]). Additionally, it was observed that the largest reduction in gambling symptoms was between the first assessment and baseline.ConclusionBoth treatments offered in this study were effective at reducing gambling symptoms. It is also possible that the process of change started before treatment, which gives promise to low-intensity interventions for GD. Additional research is needed as this approach could be both cost-effective and has the potential to reach more patients in need of treatment than is currently possible.Clinical trial registrationhttps://www.isrctn.com/, identifier ISRCTN38692394.

Project description:BackgroundDepression is three to four times more prevalent in patients with neurological and inflammatory disorders than in the general population. For example, in patients with multiple sclerosis, the 12-month prevalence of major depressive disorder is around 25% and it is associated with a lower quality of life, faster disease progression, and higher morbidity and mortality. Despite its clinical relevance, there are few treatment options for depression associated with multiple sclerosis and confirmatory trials are scarce. We aimed to evaluate the safety and efficacy of a multiple sclerosis-specific, internet-based cognitive behavioural therapy (iCBT) programme for the treatment of depressive symptoms associated with the disease.MethodsThis parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. Patients with a neurologist-confirmed diagnosis of multiple sclerosis and depressive symptoms were randomly assigned (1:1:1; automated assignment, concealed allocation, no stratification, no blocking) to receive treatment as usual plus one of two versions of the iCBT programme Amiria (stand-alone or therapist-guided) or to a control condition, in which participants received treatment as usual and were offered access to the iCBT programme after 6 months. Masking of participants to group assignment between active treatment and control was not possible, although raters were masked to group assignment. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. This trial is registered at ClinicalTrials.gov, NCT02740361, and is complete.FindingsBetween May 3, 2017, and Nov 4, 2020, we screened 485 patients for eligibility. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. The dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group (BDI-II between-group mean differences: control vs stand-alone iCBT 6·32 points [95% CI 3·37-9·27], p<0·0001, effect size d=0·97 [95% CI 0·64-1·30]; control vs guided iCBT 5·80 points [2·71-8·88], p<0·0001, effect size d=0·96 [0·62-1·30]). Clinically relevant worsening of depressive symptoms was observed in three participants in the control group, one in the stand-alone iCBT group, and none in the guided iCBT group. No occurrences of suicidality were observed during the trial and there were no deaths.InterpretationThis trial provides evidence for the safety and efficacy of a multiple sclerosis-specific iCBT tool to reduce depressive symptoms in patients with the disease. This remote-access, scalable intervention increases the therapeutic options in this patient group and could help to overcome treatment barriers.FundingNational Multiple Sclerosis Society (USA).

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A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial.

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A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial.

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