See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Study protocol
Krämer Rico
Charite Universitatsmedizin Berlin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0044-8687
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and, furthermore, the impact of an unaccompanied version vs. a therapeutic accompanied version. Subjects are randomly assigned to the unaccompanied course (without weekly calls from a psychologist), an accompanied course (with weekly calls from a psychologist), or the control group. Various secondary parameters related to online self-help programmes, such as life satisfaction, therapeutic relationship, social activation, self-esteem, attitude towards Internet interventions and drop-out rates, are also recorded.
Methods: A sample size of 400 subjects will be included. Subjects must have at least a mild to moderate depressive episode (BDI-II and Hamilton Depression Scale) and then will be randomly assigned into one of three groups: (a) immediate access to the unaccompanied depression course of “Selfapy”, (b) immediate access to the accompanied depression course of “Selfapy”, or (c) access to “Selfapy” after a 24-week delay (waiting list). The intervention period will last for a period of 12 weeks. Diagnostic assessments will take place at four different points in time: T1 (at baseline before the treatment), T2 (6 weeks after the start of the intervention), T3 (12 weeks after the start of the intervention; end of program) and T4 (3 months after completion of the treatment follow-up).
Conclusion: The effectiveness of the online self-help program "Selfapy" for depression, is to be investigated in a randomized, controlled, blinded study. Additionally, this study will utilize a “dismantled” approach to enable the comparison of the accompanied and
Trial registration: Current Controlled Trial DRKS00017191
Date of registration: 14.06.2019
Keywords
major depressive disorders, internet-based intervention, blended treatment, specialized mental healthcare, routine practice, randomized controlled trial
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 28 Jul, 2020
No community comments so far
Reviewer #2 agreed
On 17 Dec, 2020
Reviewers invited
Invitations sent on 11 Sep, 2020
Reviewer #1 agreed
On 11 Sep, 2020
Review #1 received
Received 11 Sep, 2020
Editor assigned
On 12 Aug, 2020
Submission checks complete
On 23 Jul, 2020
First submitted
On 01 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Krämer Rico
Charite Universitatsmedizin Berlin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0044-8687
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 28 Jul, 2020
No community comments so far
Reviewer #2 agreed
On 17 Dec, 2020
Reviewers invited
Invitations sent on 11 Sep, 2020
Reviewer #1 agreed
On 11 Sep, 2020
Review #1 received
Received 11 Sep, 2020
Editor assigned
On 12 Aug, 2020
Submission checks complete
On 23 Jul, 2020
First submitted
On 01 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and, furthermore, the impact of an unaccompanied version vs. a therapeutic accompanied version. Subjects are randomly assigned to the unaccompanied course (without weekly calls from a psychologist), an accompanied course (with weekly calls from a psychologist), or the control group. Various secondary parameters related to online self-help programmes, such as life satisfaction, therapeutic relationship, social activation, self-esteem, attitude towards Internet interventions and drop-out rates, are also recorded.
Methods: A sample size of 400 subjects will be included. Subjects must have at least a mild to moderate depressive episode (BDI-II and Hamilton Depression Scale) and then will be randomly assigned into one of three groups: (a) immediate access to the unaccompanied depression course of “Selfapy”, (b) immediate access to the accompanied depression course of “Selfapy”, or (c) access to “Selfapy” after a 24-week delay (waiting list). The intervention period will last for a period of 12 weeks. Diagnostic assessments will take place at four different points in time: T1 (at baseline before the treatment), T2 (6 weeks after the start of the intervention), T3 (12 weeks after the start of the intervention; end of program) and T4 (3 months after completion of the treatment follow-up).
Conclusion: The effectiveness of the online self-help program "Selfapy" for depression, is to be investigated in a randomized, controlled, blinded study. Additionally, this study will utilize a “dismantled” approach to enable the comparison of the accompanied and
Trial registration: Current Controlled Trial DRKS00017191
Date of registration: 14.06.2019
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Loading...