Social phobia moderates the outcome in the EVIDENT study: A randomized controlled trial on an Internet-based psychological intervention for mild to moderate depressive symptoms.

Purpose Individuals with advanced cancer experience substantial distress in response to disease burden and impending mortality. Managing Cancer And Living Meaningfully (CALM) is a novel, brief, manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. We conducted a randomized controlled trial to compare CALM with usual care (UC) in this population. Methods Patients with advanced cancer were recruited from outpatient oncology clinics at a comprehensive cancer center into an unblinded randomized controlled trial. Permuted block randomization stratified by Patient Health Questionnaire-9 depression score allocated participants to CALM plus UC or to UC alone. Assessments of depressive symptoms (primary outcome), death-related distress, and other secondary outcomes were conducted at baseline, 3 months (primary end point), and 6 months (trial end point). Analyses were by intention to treat. Analysis of covariance was used to test for outcome differences between groups at follow-up, controlling for baseline. Mixed-model results are reported. Results Participants (n = 305) were recruited between February 3, 2012, and March 4, 2016, and randomly assigned to CALM (n = 151) or UC (n = 154). CALM participants reported less-severe depressive symptoms than UC participants at 3 months (Δ = 1.09; P = .04; Cohen’s d = 0.23; 95% CI, 0.04 to 2.13) and at 6 months (Δ = 1.29; P = .02; d = 0.29; 95% CI, 0.24 to 2.35). Significant findings for greater end-of-life preparation at 6 months also favored CALM versus UC. No adverse effects were identified. Conclusion Findings suggest that CALM is an effective intervention that provides a systematic approach to alleviating depressive symptoms in patients with advanced cancer and addresses the predictable challenges these patients face.

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Supplemental Material for Brief Psychological Intervention in Patients With Cervical Cancer: A Randomized Controlled Trial

Health Psychology ◽

10.1037/hea0000407.supp ◽

2016 ◽

Keyword(s):

Cervical Cancer ◽

Randomized Controlled Trial ◽

Psychological Intervention ◽

Controlled Trial ◽

Randomized Controlled

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Supplemental Material for Randomized Controlled Trial of Cognitive Behavioral Stress Management in Breast Cancer: A Brief Report of Effects on 5-Year Depressive Symptoms

Health Psychology ◽

10.1037/hea0000125.supp ◽

2014 ◽

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Stress Management ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Cognitive Behavioral Stress Management ◽

Randomized Controlled ◽

Behavioral Stress

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An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05089-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Noemi Anja Brog ◽

Julia Katharina Hegy ◽

Thomas Berger ◽

Hansjörg Znoj

Keyword(s):

Randomized Controlled Trial ◽

Psychological Distress ◽

Depressive Symptoms ◽

Controlled Trial ◽

The Self ◽

Randomized Controlled ◽

Self Help ◽

Parallel Group ◽

Related Quality ◽

Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

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