A randomized controlled trial of internet-based therapy in depression

Depression is among the most prevalent disorders worldwide. In view of numerous treatment barriers, internet-based interventions are increasingly adopted to “treat the untreated”. The present trial (registered as NCT01401296) was conducted over the internet and aimed to assess the efficacy of an online self-help program for depression (Deprexis). In random order, participants with elevated depression symptoms received program access or were allocated to a wait-list control condition. After eight weeks, participants were invited to take part in an online re-assessment. To compensate for common problems of online studies, such as low completion rates and unclear diagnostic status, reminders and incentives were used, and clinical diagnoses were externally confirmed in a subgroup of 29% of participants. Relative to the wait-list group, program users experienced significant symptom decline on the Beck Depression Inventory (BDI; primary outcome), the Dysfunctional Attitudes Scale (DAS), the Quality of Life scale (WHOQOL-BREF) and the Rosenberg Self-Esteem Scale (RSE). Compared to wait-list participants, symptom decline was especially pronounced among those with moderate symptoms at baseline as well as those not currently consulting a therapist. Completion (82%) and re-test reliability of the instruments (r = .72–.87) were good. The results of this trial suggest that online treatment can be beneficial for people with depression, particularly for those with moderate symptoms.     

A randomized trial of a brief primary-care-based intervention for reducing at-risk drinking practices.

This randomized trial evaluated an intervention for reducing at-risk drinking practices in a sample of 307 patients. Eligible drinking patterns included chronic drinking (> or = 2 drinks per day in the past month), binge drinking (> or = 5 drinks per occasion at least twice in the past month), and drinking and driving (driving after > 2 drinks in the past month). Members of the intervention group received a message from their physician during their regularly scheduled visit, a self-help manual, written personalized feedback, and up to 3 telephone counseling calls. Dropout was significantly higher in the intervention than control group.     

Motivational enhancement therapy for African American substance users: a randomized clinical trial

Limited empirical evidence concerning the efficacy of substance abuse treatments among African Americans reduces opportunities to evaluate and improve program efficacy. The current study, conducted as a secondary analysis of a randomized clinical trial conducted by the Clinical Trials Network of the National Institute of Drug Abuse, addressed this knowledge gap by examining the efficacy of motivational enhancement therapy (MET) compared with counseling as usual (CAU) among 194 African American adults seeking outpatient substance abuse treatment at 5 participating sites. The findings revealed higher retention rates among women in MET than in CAU during the initial 12 weeks of the 16-week study. Men in MET and CAU did not differ in retention. However, MET participants self-reported more drug-using days per week than participants in CAU. Implications for future substance abuse treatment research with African Americans are discussed.     

Reducing depression in stroke survivors and their informal caregivers: A randomized clinical trial of a web-based intervention

Purpose/Objectives: To develop and test the efficacy of a Web-based intervention for alleviating depression in male stroke survivors (SSs) and their spousal caregivers (CGs) that blends both peer and professional support. Design and Methods: The research consisted of an intervention protocol evaluated by a focus group of rehabilitation professionals, a "think aloud" session conducted with female stroke CGs, and a usability test of the intervention's online features with 7 female stroke CGs. Efficacy of the final protocol was tested in a 2-group randomized clinical trial with a sample of 32 CG-SS dyads. The CGs in the intervention condition received an online group intervention. Intervention components were based on the Stress Process Model. Those CGs in a control condition received minimal support with individualized access to relevant online information. Measures of depression, as well as the secondary outcomes of mastery, self-esteem, and social support, were obtained from SSs and CGs at pretest, posttest, and 1-month later. Results: At posttest and 1 month later, CGs in the intervention condition reported significantly lower depression than CGs in the control condition with baseline depression controlled. There was no significant effect on depression among SSs. Although no significant treatment effects for either SSs or CGs were found on the secondary outcomes, posttreatment changes on some constructs were significantly correlated with change in depression. Conclusions/Implications: CGs benefit from Web-based programs that help them better understand both their emotional needs and those of the SS. (PsycINFO Database Record (c) 2012 APA, all rights reserved).     

An open trial of a brief transdiagnostic internet treatment for anxiety and depression

The present study evaluated the efficacy of a brief version of an internet-administered transdiagnostic CBT protocol, the Wellbeing Program (Titov et al., 2011), designed to treat three anxiety disorders and major depression within the same program. This brief version included the same core CBT skills as the original, but condensed the materials from 8 to 5 online lessons, reduced the duration of treatment from 10 to 8 weeks and did not include an online forum. Thirty-two individuals with a principal diagnosis of major depression, generalised anxiety disorder, panic disorder or social phobia received CBT-based online educational lessons, homework assignments, weekly contact from a clinical psychologist and automated emails. Eighty-one percent of participants completed the lessons within the 8 week program. Post-treatment and 3-month follow-up data were collected from 28/32 and 31/32 participants respectively. Participants improved significantly on the Depression Anxiety and Stress Scales – 21 Item, Patient Health Questionnaire – 9 Item, and Generalised Anxiety Disorder – 7 Item scales, with corresponding within-group effect sizes (Cohen’s d) at follow-up of 1.05, .73, and .95, respectively. Participants rated the procedure as highly acceptable with gains of a similar magnitude as those found for the original program, but less time was spent per participant by the clinician in the present trial (mean = 44.61 min, SD = 34.45) compared to the original program (mean = 84.76 min, SD = 50.37). These results provide additional support for the efficacy of transdiagnostic iCBT in the treatment of anxiety and depressive disorders and indicate that a brief version may be of benefit.     

Efficacy of brief guided self-help cognitive behavioral treatment for perfectionism in reducing perinatal depression and anxiety: a randomized controlled trial

Perfectionism has been proposed as a transdiagnostic process that maintains depression and anxiety through shared cognitive and behavioral processes. The purpose of this study was to investigate the efficacy of a brief, guided cognitive behavioral treatment (CBT) for perfectionism delivered via a self-help booklet in reducing perfectionism and symptoms of depression and anxiety during the antenatal period. Pregnant women in their third trimester were randomly allocated to self-help (n = 30) or waitlist control (n = 30). There were significant reductions in perfectionism and symptoms for participants who received CBT for perfectionism from pre- to post-treatment, which were maintained at 3-month follow-up, while the waitlist control group demonstrated no significant changes. Path analysis demonstrated a significant indirect effect of treatment condition on post-treatment depression and anxiety scores via perfectionism, controlling for pre-treatment scores, suggesting changes in perfectionism were associated with decreases in symptoms. The findings suggest that it would be useful for future research with larger samples to further investigate the efficacy of CBT for perfectionism for perinatal depression and anxiety.     

Parent-child interaction therapy for Mexican Americans: results of a pilot randomized clinical trial at follow-up

We examined treatment effects over a 6- to 24-month period posttreatment for 3 different interventions for externalizing behavior problems in young Mexican American (MA) children: a culturally modified version of Parent–Child Interaction Therapy (PCIT), called Guiando a Niños Activos (GANA), standard PCIT, and treatment as usual (TAU). Fifty-eight MA families with a 3- to 7-year-old child with clinically significant behavior problems were randomly assigned to GANA, standard PCIT, or TAU. As previously reported, all three treatment approaches produced significant pre-post improvement in conduct problems across a wide variety of parent-report measures, and those effects remained significant over the follow-up period. GANA produced results that were significantly superior to TAU on 6 out of 10 parent-report measures 6 to 24 months posttreatment, and GANA significantly outperformed PCIT on child internalizing symptoms. However, PCIT and TAU did not differ significantly from one another. These data suggest that both PCIT and GANA produce treatment gains that are maintained over time, and that GANA continues to outperform TAU over the long term.     

Congruence couple therapy for alcohol use and gambling disorders with comorbidities (part I): Outcomes from a randomized controlled trial

A nonblinded randomized trial was conducted at two Canadian provincial outpatient addiction clinics that tested the effectiveness of a systemic congruence couple therapy (CCT) versus individual-based treatment-as-usual (TAU) on nine clinical outcomes: (1) primary outcomes—alcohol use and gambling, psychiatric symptoms, and couple adjustment; (2) secondary outcomes—emotion regulation, substance use, depression, post-traumatic stress symptoms, and life stress. Data of primary clients and partners (N = 46) were analyzed longitudinally across baseline, posttreatment (5 months), and follow-up (8 months). Alcohol use disorder (95%) and gambling disorder (5%) were in the severe range at baseline, and co-addiction was 27%. Psychiatric comorbidity was 100%, and 18% of couples were jointly addicted. Between-group comparison favored CCT in primary outcomes with medium-to-large effect sizes (Cohen's h = 0.74–1.44). Secondary outcomes were also significantly stronger for CCT (Cohen's h = 0.27–1.53). Within-group, for all primary outcomes, a significant proportion of symptomatic CCT clients and partners improved, converging with ANOVA results of large effect sizes (0.14–0.29). All secondary outcomes improved significantly in CCT with large effect sizes (0.14–0.50). TAU showed significant within-group improvement in alcohol use, other substance use, and life stress with large effect sizes (0.16–0.40). Primary clients and partners made largely equivalent improvement within CCT and within TAU. Results were triangulated with clients' satisfaction ratings and counselors' reports. Overall, significant within-group effects were detected for CCT both clinically and statistically and between-group difference favored CCT. Future trials are required to validate these promising findings.     

A randomized clinical trial of online-biblio relationship education for expectant couples

This study evaluated the efficacy of a self-paced, Internet-based marriage and relationship skills education program ("Power of Two Online"). The program integrated an online intervention with print supplemental resources. New and expectant parents (n = 79) were randomly assigned to the 2-month intervention or placebo-control group. Assessments were conducted at baseline, 1-month, and 2-month follow-up intervals. Latent growth curve modeling was used to examine differences between conditions for marital satisfaction and conflict management. Participants who received the intervention reported trajectories of improved marital satisfaction and improved marital conflict management over time relative to controls. Implications for widespread dissemination of marriage and relationship education as a primary prevention tool are discussed.     

Internet administered guided self-help versus individualized e-mail therapy: A randomized trial of two versions of CBT for major depression

Internet-delivered psychological treatment of major depression has been investigated in several trials, but the role of personalized treatment is less investigated. Studies suggest that guidance is important and that automated computerized programmes without therapist support are less effective. Individualized e-mail therapy for depression has not been studied in a controlled trial. Eighty-eight individuals with major depression were randomized to two different forms of Internet-delivered cognitive behaviour therapy (CBT), or to a waiting-list control group. One form of Internet treatment consisted of guided self-help, with weekly modules and homework assignments. Standard CBT components were presented and brief support was provided during the treatment. The other group received e-mail therapy, which was tailored and did not use the self-help texts i.e., all e-mails were written for the unique patient. Both treatments lasted for 8 weeks. In the guided self-help 93% completed (27/29) and in the e-mail therapy 96% (29/30) completed the posttreatment assessment. Results showed significant symptom reductions in both treatment groups with moderate to large effect sizes. At posttreatment 34.5% of the guided self-help group and 30% of the e-mail therapy group reached the criteria of high-end-state functioning (Beck Depression Inventory score below 9). At six-month follow-up the corresponding figures were 47.4% and 43.3%. Overall, the difference between guided self-help and e-mail therapy was small, but in favour of the latter. These findings indicate that both guided self-help and individualized e-mail therapy can be effective.     

The clinical representativeness of couple therapy outcome research

The clinical representativeness of outcome studies is defined as the generalizability of recruitment processes, assessment/diagnostic procedures, treatment protocols, and therapeutic results from research settings to naturalistic treatment settings. The main goal of the present study was to examine the clinical representativeness of couple therapy in outcome studies. The data set was formed by 50 published clinical trials, including 34 couple therapy outcome studies for marital distress (CTMD) and 16 couple therapy outcome studies for comorbid relational and mental disorders (CTMD + C). The present findings showed that, overall, the clinical representativeness of couple therapy outcome studies is only fair (i.e., the mean global score is slightly lower than the midpoint of the rating scale used to assess representativeness). CTMD + C studies fared better than CTMD studies on many dimensions of clinical relevance. Studies in which pretherapy training was less intensive (for CTMD studies only), treatment was less structured, and therapists were more experienced showed larger effect sizes than those in which such was not the case.     

A cluster randomized controlled trial of brief follow-up practice sessions on intervention maintenance

Despite considerable knowledge of the factors that influence initial intervention response, little is known about how to sustain successful intervention response over time. The current study examined spring literacy outcomes for kindergarten (n = 177), second (n = 149), and third grade students (n = 204) who successfully exited an evidence-based tutoring program during the fall semester. Successful responders in kindergarten, second, and third grade were randomly assigned by school to receive either no follow-up support or access to a once-weekly oral practice session. Results were mixed across grades and outcomes, but in kindergarten and third grade, treatment corresponded to an approximately 15% increased likelihood of meeting year-end benchmarks on targeted literacy skills. Findings are discussed in the context of suggestions for higher-quality longitudinal research designs of educational interventions.     

A randomized controlled trial of cognitive behavior therapy for borderline personality disorder: rationale for trial, method, and description of sample

This paper describes the rationale for a randomized controlled trial, comparing cognitive behavior therapy in addition to treatment as usual with treatment as usual alone, for borderline personality disorder. Previous pioneering randomized controlled trials of psychotherapies have suffered from methodological weaknesses and have not always been reported clearly to allow adequate evaluation of either the individual study or comparisons across studies to be undertaken. We report on the recruitment and randomization, design, and conduct of an ongoing randomized controlled trial of one hundred and six patients with borderline personality disorder. Primary and secondary hypotheses and their planned analyses are stated. The baseline characteristics of 106 patients meeting diagnostic criteria for borderline personality disorder are described.     

Metacognitive therapy in treatment-resistant depression: a platform trial

Patients with treatment-resistant depression received up to 8 sessions of metacognitive therapy (MCT) targeting attentional control, rumination, worry, and metacognitive beliefs. A baseline period was followed by weekly sessions with follow-up assessments at 6 and 12 months post treatment. Large and statistically significant improvements occurred in all symptom measures at post treatment and were maintained over follow-up. Two out of 3 process measures significantly improved at post treatment and all of these measures were improved at follow-up. Treatment was associated with similar response rates on the BDI and Hamilton rating scale. Using liberal criteria 80% of completers were classified as recovered at post treatment and 70% at follow-up on the BDI. In the intention to treat sample 66.6% were recovered at post treatment and 58.3% at follow-up. More stringent criteria showed 60% recovery rates at post treatment and at 12 m. The results suggest that MCT could be a brief and effective treatment and they provide a precedent for more definitive randomized controlled trials.     

Cognitive behavior therapy for driving fear: A pilot randomized controlled trial

Fear of driving is common in clinical practice, while its treatment programs are understudied. This is the first randomized controlled trial to evaluate a newly developed protocol for cognitive behavior therapy (CBT) for driving fear compared with a wait list and to use specific assessment scales. 34 participants (30 women, 4 men) in an outpatient psychotherapy clinic were randomly allocated to either 18 sessions of CBT or a wait list (n = 17 each). After treatment, CBT was significantly more efficacious than the wait list with large effect sizes on the Instrument for Fear of Driving (IFD) (Cohen’s d = 2.58) and on the Driving Cognitions Questionnaire (DCQ) (Cohen’s d = 2.14). Driving fear is a condition treatable by CBT and the suggested protocol is safe, feasible and acceptable. Further studies with larger samples and active controls (e.g., virtual reality therapy) are required to draw generalizable conclusions on effect sizes.     

Prevention of depression with primary care patients: A randomized controlled trial

The prevention of major depression is an important research goal which deserves increased attention. Depressive symptoms and disorders are particularly common in primary care patients and have a negative impact on functioning and well-being comparable with other major chronic medical conditions. The San Francisco Depression Prevention Research project conducted a randomized, controlled, prevention trial to demonstrate the feasibility of implementing such research in a public sector setting serving low-income, predominantly minority individuals: 150 primary care patients free from depression or other major mental disorders were randomized to an experimental cognitive-behavioral intervention or to a control condition. The experimental intervention group reported a significantly greater reduction in depressive levels. Decline in depressive levels was significantly mediated by decline in the frequency of negative conditions. Group differences in the number of new episodes (incidence) of major depression did not reach significance during the 1-year trial. We conclude that depression prevention trials in public sector primary care settings are feasbile, and that depressive symptoms can be reduced even in low-income, minority populations. To conduct randomized prevention trials that can test effects on incidence with sufficient statistical power, subgroups at greater imminent risk have to be identified.