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Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial.

ABSTRACT: Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor. Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD.This is an NIMH-funded R01-level randomized clinical trial to test the efficacy of a novel, SAD-tailored cognitive-behavioral group therapy (CBT) against LT in a head-to-head comparison on next winter outcomes. This project is designed to test for a clinically meaningful difference between CBT and LT on depression recurrence in the next winter (the primary outcome). This is a concurrent two-arm study that will randomize 160 currently symptomatic community adults with major depression, recurrent with seasonal pattern, to CBT or LT. After 6 weeks of treatment in the initial winter, participants are followed in the subsequent summer, the next winter, and two winters later. Key methodological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes.The chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT. This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT's outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint. Alternative designs addressing these limitations would have required more patients, increased costs, and reduced power to detect a difference in the primary outcome.Clinicaltrials.gov identifier NCT01714050.

SUBMITTER: Rohan KJ

PROVIDER: S-EPMC3652773 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial.

Rohan Kelly J KJ Evans Maggie M Mahon Jennifer N JN Sitnikov Lilya L Ho Sheau-Yan SY Nillni Yael I YI Postolache Teodor T TT Vacek Pamela M PM

Trials 20130321

<h4>Background</h4>Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter sea ...[more]

PMID: 23514124

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Project description:Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy.This study is a two-arm pragmatic randomised controlled superiority trial comparing the effectiveness of group-based rumination-focused cognitive behaviour therapy with the effectiveness of group-based cognitive behavioural therapy for treatment of depression. One hundred twenty-eight patients with depression will be recruited from and given treatment in an outpatient service at a psychiatric hospital in Denmark. Our primary outcome will be severity of depressive symptoms (Hamilton Rating Scale for Depression) at completion of treatment. Secondary outcomes will be level of rumination, worry, anxiety, quality of life, behavioural activation, experimental measures of cognitive flexibility, and emotional attentional bias. A 6-month follow-up is planned and will include the primary outcome measure and assessment of relapse.The clinical outcome of this trial may guide clinicians to decide on the merits of including rumination-focused cognitive behavioural therapy in the treatment of depression in outpatient services.ClinicalTrials.gov Identifier: NCT02278224 , registered 28 Oct. 2014.

Project description:STUDY OBJECTIVES:The current archival analyses examine the direct and indirect effects of cognitive behavioral therapy for insomnia (CBT-I) on depression in cancer survivors. METHODS:We report on 67 cancer survivors from a 2 × 2 randomized controlled trial of CBT-I and armodafinil for insomnia, after collapsing across the noneffective study medication conditions (armodafinil/placebo) to create CBT-I (yes/no). Depression and insomnia were assessed before, during the 7-week CBT-I intervention, at postintervention, and 3 months later by the Patient Health Questionnaire and the Insomnia Severity Index, respectively. RESULTS:Mean depression at baseline for all participants was 6.44 (standard error = 0.41, range 0-15). Paired t tests showed that depression improved from baseline to postintervention by 48% (P < .001) in the CBT-I group versus 15% (P = .016) in the non-CBT-I group. Analysis of covariance controlling for baseline found that participants receiving CBT-I had significantly less depression at postintervention (effect size = -0.62; P = .001), compared to those who did not receive CBT-I. These benefits were maintained at the 3-month follow-up. Spearman rank correlations showed that changes in insomnia severity from baseline to postintervention were significantly correlated with concurrent changes in depression (r = .73; P < .001). Path analysis revealed that improvement in depression was mediated by improvement in insomnia severity (P < .001). CONCLUSIONS:Our findings provide preliminary support that in cancer survivors, CBT-I reduces depression via improvement in insomnia. Further, this reduction in depression remained stable 3 months after completing CBT-I. This suggests that a CBT-I intervention has a meaningful effect on depression. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy; Identifier: NCT01091974; URL: https://clinicaltrials.gov/ct2/show/record/NCT01091974.

Project description:BackgroundPrevention of depression is a priority to reduce its global disease burden. Targeting specific risk factors, such as rumination, may improve prevention. Rumination-focused Cognitive Behavioral Therapy (RFCBT) was developed to specifically target depressive rumination.ObjectiveThe primary objective of this study was to test whether guided Web-based RFCBT (i-RFCBT) would prevent the incidence of major depression relative to usual care in UK university students. The secondary objective was to test the feasibility and estimated effect sizes of unguided i-RFCBT.MethodsTo address the primary objective, a phase III randomized controlled trial was designed and powered to compare high risk university students (N=235), selected with elevated worry/rumination, recruited via an open access website in response to circulars within universities and internet advertisements, randomized to receive either guided i-RFCBT (interactive Web-based RFCBT, supported by asynchronous written Web-based support from qualified therapists) or usual care control. To address the secondary objective, participants were also randomized to an adjunct arm of unguided (self-administered) i-RFCBT. The primary outcome was the onset of a major depressive episode over 15 months, assessed with structured diagnostic interviews at 3 (postintervention), 6, and 15 months post randomization, conducted by telephone, blind to the condition. Secondary outcomes of symptoms of depression and anxiety and levels of worry and rumination were self-assessed through questionnaires at baseline and the same follow-up intervals.ResultsParticipants were randomized to guided i-RFCBT (n=82), unguided i-RFCBT (n=76), or usual care (n=77). Guided i-RFCBT reduced the risk of depression by 34% relative to usual care (hazard ratio [HR] 0.66, 95% CI 0.35 to 1.25; P=.20). Participants with higher levels of baseline stress benefited most from the intervention (HR 0.43, 95% CI 0.21 to 0.87; P=.02). Significant improvements in rumination, worry, and depressive symptoms were found in the short-to-medium term. Of the 6 modules, guided participants completed a mean of 3.46 modules (SD 2.25), with 46% (38/82) being compliant (completing ?4 modules). Similar effect sizes and compliance rates were found for unguided i-RFCBT.ConclusionsGuided i-RFCBT can reduce the onset of depression in high-risk young people reporting high levels of worry/rumination and stress. The feasibility study argues for formally testing unguided i-RFCBT for prevention: if the observed effect sizes are robustly replicated in a phase III trial, it has potential as a scalable prevention intervention.Trial registrationISRCTN Registry ISRCTN12683436; https://www.isrctn.com/ISRCTN12683436 (Archived by WebCite at http://www.webcitation.org/77fqycyBX).International registered report identifier (irrid)RR2-10.1186/s13063-015-1128-9.

Project description:ImportanceOwing to biological, behavioral, and societal factors, sleep duration in teenagers is often severely truncated, leading to pervasive sleep deprivation.ObjectiveTo determine whether a novel intervention, using both light exposure during sleep and cognitive behavioral therapy (CBT), would increase total sleep time in teenagers by enabling them to go to sleep earlier than usual.Design, setting, and participantsThis double-blind, placebo-controlled, randomized clinical trial, conducted between November 1, 2013, and May 31, 2016, among 102 adolescents enrolled full-time in grades 9 to 12, who expressed difficulty going to bed earlier and waking up early enough, was composed of 2 phases. In phase 1, participants were assigned to receive either 3 weeks of light or sham therapy and were asked to try to go to sleep earlier. In phase 2, participants received 4 brief CBT sessions in addition to a modified light or sham therapy. All analyses were performed on an intent-to-treat basis.InterventionsLight therapy consisted of receiving a 3-millisecond light flash every 20 seconds during the final 3 hours of sleep (phase 1) or final 2 hours of sleep (phase 2). Sham therapy used an identical device, but delivered 1 minute of light pulses (appearing in 20-second intervals, for a total of 3 pulses) per hour during the final 3 hours of sleep (phase 1) or 2 hours of sleep (phase 2). Light therapy occurred every night during the 4-week intervention. Cognitive behavioral therapy consisted of four 50-minute in-person sessions once per week.Main outcomes and measuresPrimary outcome measures included diary-based sleep times, momentary ratings of evening sleepiness, and subjective measures of sleepiness and sleep quality.ResultsAmong the 102 participants (54 female [52.9%]; mean [SD] age, 15.6 [1.1] years), 72 were enrolled in phase 1 and 30 were enrolled in phase 2. Mixed-effects models revealed that light therapy alone was inadequate in changing the timing of sleep. However, compared with sham therapy plus CBT alone, light therapy plus CBT significantly moved sleep onset a mean (SD) of 50.1 (27.5) minutes earlier and increased nightly total sleep time by a mean (SD) of 43.3 (35.0) minutes. Light therapy plus CBT also resulted in a 7-fold greater increase in bedtime compliance than that observed among participants receiving sham plus CBT (mean [SD], 2.21 [3.91] vs 0.29 [0.76]), as well as a mean 0.55-point increase in subjective evening sleepiness as compared with a mean 0.48-point decrease in participants receiving sham plus CBT as measured on a 7-point sleepiness scale.Conclusions and relevanceThis study found that light exposure during sleep, in combination with a brief, motivation-focused CBT intervention, was able to consistently move bedtimes earlier and increase total sleep time in teenagers. This type of passive light intervention in teenagers may lead to novel therapeutic applications.Trial registrationClinicalTrials.gov identifier: NCT01406691.

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Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial.

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Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial.

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