Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

Abstract

Background Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the supply of low-threshold treatment. Further research is needed to evaluate the effectiveness of online interventions. This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and compares the impact of the programme’s unaccompanied version with its therapeutic accompanied version. Methods A sample of 400 subjects that have a mild to severe depressive episode (Becks Depression Inventory - II and Hamilton Depression Scale) will be used. Subjects are randomly assigned to immediate access to an unaccompanied course (no support from psychologist via weekly phone calls), immediate access to an accompanied course (support from a psychologist via weekly phone calls) or a waiting list control group (access to the intervention after 24 weeks). The intervention will last for a period of 12 weeks. Depressive symptoms as a primary parameter, as well as various secondary parameters, such as life satisfaction, therapeutic relationships, social activation, self-esteem, attitudes towards Internet interventions and drop-out rates, are recorded at four different points in time: at baseline (T1), 6 weeks after the start of the intervention (T2), 12 weeks after the start of the intervention (T3) and 3 months after completion of the treatment follow-up (T4). Conclusion This randomized and controlled, blinded study will make use of a “dismantled” approach to adequately compare the accompanied and unaccompanied versions of the intervention. Positive and meaningful results are expected that could influence the acceptance and implementation of online interventions. Trial registration German Clinical Trials Register DRKS00017191. Registered on 14 June 2019

Acceptance of E-Mental Health Services for Different Application Purposes Among Psychotherapists in Clinical Training in Germany and Switzerland: Secondary Analysis of a Cross-Sectional Survey

“…Potentially, PiT prefer having more visible control of the acute treatment process including the therapeutic alliance and feel more comfortable with direct synchronous communication, including the interpretation of verbal and nonverbal signals. Interestingly, the evidence base of the effectiveness of psychotherapy via videoconference or telephone is a still a growing research area ( 60 , 61 , 81 , 82 ) and there is considerably more evidence on the treatment effectiveness and acceptance of structured EMH self-help programs such as minimally guided iCBT which also forms the basis of some medical apps for mental health ( 48 ). From the perspective of potential clients, individuals seem to generally prefer these therapist-guided internet interventions such as iCBT over videoconferencing and unguided internet interventions when they have to choose between different EMH services ( 25 ) as well as blended delivery modes combining online or telephone contact with face-to-face psychotherapeutic sessions ( 83 ).…”

“…About a decade ago, Eichenberg and Ott ( 44 ) could show that most EMH services were used for treatment (71%), 19.1% for prevention and only 9% for rehabilitation purposes. Meanwhile, digital health applications (medical apps) for mental health such as selfapy ( 48 ), velibra ( 49 ) or deprexis ( 50 ) have been integrated into routine care in Germany in fall 2020 and are now used along the entire patient journey ( 51 ). Medical apps are guided or unguided programs which are self-directed mobile phone- or web-based programs that entail information and a fixed number of modules or exercises for (mental) health problems ( 12 , 48 , 50 ).…”

“…Meanwhile, digital health applications (medical apps) for mental health such as selfapy ( 48 ), velibra ( 49 ) or deprexis ( 50 ) have been integrated into routine care in Germany in fall 2020 and are now used along the entire patient journey ( 51 ). Medical apps are guided or unguided programs which are self-directed mobile phone- or web-based programs that entail information and a fixed number of modules or exercises for (mental) health problems ( 12 , 48 , 50 ). Oftentimes, the basis of guided medical apps is internet-based cognitive behavioral therapy (iCBT) which involves the user following a written electronic treatment program, together with receiving synchronous or asynchronous support from a therapist via e-mail, texts or calls ( 52 ).…”

Efficacy of a Web-Based Intervention for Depressive Disorders: Three-Arm Randomized Controlled Trial Comparing Guided and Unguided Self-Help With Waitlist Control

“…The central recruiting tool was a study website through which interested individuals could register their participation. This preregistered trial was conducted according to the study protocol [ 13 ].…”

“…Individuals who were excluded from the study due to illness severity were advised to seek professional help. Additional details have been previously published [ 13 ].…”