An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial

Background: A cancer diagnosis can cause severe emotional distress and affect quality of life as well as social relationships. The transition from inpatient to outpatient treatment is burdened by stressful uncertainties and a gap of psycho-oncological care. In addition, further barriers, such as inf...

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Main Authors: Angeliki Tsiouris, Anna Mayer, Charlotte Nölke, Christian Ruckes, Nicole Labitzke, Jörg Wiltink, Manfred E. Beutel, Rüdiger Zwerenz
Format: Article
Language:English
Published: Elsevier 2021-09-01
Series:Internet Interventions
Subjects:
RCT
Online Access:http://www.sciencedirect.com/science/article/pii/S2214782921000506
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spelling doaj-a98e9831a0ed4c9491dbbf6330d916ef2021-08-02T04:40:58ZengElsevierInternet Interventions2214-78292021-09-0125100410An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trialAngeliki Tsiouris0Anna Mayer1Charlotte Nölke2Christian Ruckes3Nicole Labitzke4Jörg Wiltink5Manfred E. Beutel6Rüdiger Zwerenz7Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, Germany; Corresponding author at: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Untere Zahlbacher Str. 8, 55131 Mainz, Germany.Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, GermanyInterdisciplinary Center for Clinical Trials, University Medical Center Mainz, Mainz, GermanyCenter for Audiovisual Production, Johannes Gutenberg-University, Mainz, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Mainz, GermanyBackground: A cancer diagnosis can cause severe emotional distress and affect quality of life as well as social relationships. The transition from inpatient to outpatient treatment is burdened by stressful uncertainties and a gap of psycho-oncological care. In addition, further barriers, such as information deficits or fear of stigmatization, might hinder cancer patients to use psycho-oncological face-to-face interventions. Online interventions can be a low-threshold adjunct to existing face-to-face services. This study aims to evaluate the effect of the online self-help program epos (emotion-based psycho-oncological online self-help) on improving symptoms of anxiety and depression in German-speaking cancer patients. Methods: A randomized controlled trial (RCT) is carried out in a parallel group design. N = 325 patients will be enrolled in the trial, randomly assigned to an intervention and a control group. While the intervention group has access to nine modules of epos, the control group gets access to an informational website. Participants will complete online questionnaires at baseline (T0), after the intervention (T1) and three-month follow-up (T2). Primary outcome is a combined measure of depression and anxiety. Secondary outcomes include psychological distress, anxiety, depression, quality of life, emotional control, posttraumatic growth, and satisfaction with epos. Participants are at least 18 years old, have a cancer diagnosis, currently receive cancer treatment or aftercare, have sufficient German language competence, and have access to the Internet. Exclusion criteria are severe mental comorbidities (i.e. severe depression, suicidality) or somatic comorbidities (i.e. visual disabilities). Discussion: The results of this study will provide information about acceptability, feasibility, and efficacy of epos in improving symptoms of depression and anxiety in cancer patients and thus contribute to the research on web-based interventions. If found efficacious, epos will improve psycho-oncological care in cancer patients in transition from inpatient to outpatient care and in those who struggle to find adequate psycho-oncological support due to other (perceived) barriers.http://www.sciencedirect.com/science/article/pii/S2214782921000506CancerPsycho-oncologyOnline interventionPsychological distressRCTE-mental health
collection DOAJ
language English
format Article
sources DOAJ
author Angeliki Tsiouris
Anna Mayer
Charlotte Nölke
Christian Ruckes
Nicole Labitzke
Jörg Wiltink
Manfred E. Beutel
Rüdiger Zwerenz
spellingShingle Angeliki Tsiouris
Anna Mayer
Charlotte Nölke
Christian Ruckes
Nicole Labitzke
Jörg Wiltink
Manfred E. Beutel
Rüdiger Zwerenz
An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial
Internet Interventions
Cancer
Psycho-oncology
Online intervention
Psychological distress
RCT
E-mental health
author_facet Angeliki Tsiouris
Anna Mayer
Charlotte Nölke
Christian Ruckes
Nicole Labitzke
Jörg Wiltink
Manfred E. Beutel
Rüdiger Zwerenz
author_sort Angeliki Tsiouris
title An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial
title_short An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial
title_full An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial
title_fullStr An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial
title_full_unstemmed An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial
title_sort emotion-based online intervention for reducing anxiety and depression in cancer patients: study protocol for a randomized controlled trial
publisher Elsevier
series Internet Interventions
issn 2214-7829
publishDate 2021-09-01
description Background: A cancer diagnosis can cause severe emotional distress and affect quality of life as well as social relationships. The transition from inpatient to outpatient treatment is burdened by stressful uncertainties and a gap of psycho-oncological care. In addition, further barriers, such as information deficits or fear of stigmatization, might hinder cancer patients to use psycho-oncological face-to-face interventions. Online interventions can be a low-threshold adjunct to existing face-to-face services. This study aims to evaluate the effect of the online self-help program epos (emotion-based psycho-oncological online self-help) on improving symptoms of anxiety and depression in German-speaking cancer patients. Methods: A randomized controlled trial (RCT) is carried out in a parallel group design. N = 325 patients will be enrolled in the trial, randomly assigned to an intervention and a control group. While the intervention group has access to nine modules of epos, the control group gets access to an informational website. Participants will complete online questionnaires at baseline (T0), after the intervention (T1) and three-month follow-up (T2). Primary outcome is a combined measure of depression and anxiety. Secondary outcomes include psychological distress, anxiety, depression, quality of life, emotional control, posttraumatic growth, and satisfaction with epos. Participants are at least 18 years old, have a cancer diagnosis, currently receive cancer treatment or aftercare, have sufficient German language competence, and have access to the Internet. Exclusion criteria are severe mental comorbidities (i.e. severe depression, suicidality) or somatic comorbidities (i.e. visual disabilities). Discussion: The results of this study will provide information about acceptability, feasibility, and efficacy of epos in improving symptoms of depression and anxiety in cancer patients and thus contribute to the research on web-based interventions. If found efficacious, epos will improve psycho-oncological care in cancer patients in transition from inpatient to outpatient care and in those who struggle to find adequate psycho-oncological support due to other (perceived) barriers.
topic Cancer
Psycho-oncology
Online intervention
Psychological distress
RCT
E-mental health
url http://www.sciencedirect.com/science/article/pii/S2214782921000506
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