Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480474
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Brief Title:
Internet-based Treatment for Depression
Sponsor:
University of Fribourg
Organization:
University of Fribourg
Study Overview
Official Title:
Internet-based Treatment for Depression a Randomized Controlled Trial Comparing Therapist Support and Peer-support Using an Online Forum
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBAT-D
Brief Summary:
The overall aim of the present project is to test the efficacy of a validated Internet-based self-help program for depression developed in Germany in the French part of Switzerland The program has shown to be efficacious in different trials with major depression and depression as a comorbidity of another disorder eg gambling addiction epilepsy The objectives of this project are
Primary Objective To test the effects of the self-help web-based program on depressive symptoms in French-speaking individuals in Switzerland
Secondary Objective A To test the effects of the online program on reward responses for individuals with depressive symptoms
Secondary Objectives B and C To test the effects of the role of peer-to-peer support using an online forum in addition to an online program B and comparison between Switzerland and India C
This project can inform clinicians about what they can offer as a treatment to individuals either in combination with psychotherapy or when there is no quick or direct access to a psychotherapist The study promises to have a direct practical significance for people suffering from depression
Primary Objective To test the effects of the self-help web-based program on depressive symptoms in French-speaking individuals in Switzerland
Secondary Objective A To test the effects of the online program on reward responses for individuals with depressive symptoms
Secondary Objectives B and C To test the effects of the role of peer-to-peer support using an online forum in addition to an online program B and comparison between Switzerland and India C
This project can inform clinicians about what they can offer as a treatment to individuals either in combination with psychotherapy or when there is no quick or direct access to a psychotherapist The study promises to have a direct practical significance for people suffering from depression
Detailed Description:
Depression is one of the most frequent mental disorders that affect society and individuals psychologically and financially The text revision of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders DSM-5-TR defines characterized depression as a minimum of 2 weeks of low mood or loss of interest in daily activities accompanied by vegetative motor and cognitive symptoms Depressed individuals may also have suicidal thoughts or tendencies However not everyone receives adequate care and there is a treatment gap The causes of the treatment gap are diverse and include the difficulty in accessing treatment the lack of mental health specialists in a region or a country the fear of stigmatization cultural beliefs about mental health etc Technologies such as Internet-based self-help interventions are promising to reduce the burden of depression and to address the treatment gap Several meta-analyses found that these interventions are effective in reducing depression Internet-based self-help interventions are easily available can be utilized regardless of time and location and can be provided to a large population simultaneously Although Switzerland has a well-developed mental health care the treatment gap for depression in Switzerland is estimated to be 51 and depression represents a strong societal burden The main aim of this study will be to examine the efficacy of a web-based self-help intervention for depression in the French-speaking part of Switzerland in a randomized clinical trial
Moreover anhedonia is a core symptom of depression It is defined as a loss of pleasure or a lack of reactivity when faced with pleasurable stimuli Hedonic capacity decreases with depression such as a reduced reactivity to pleasant cues or diminished reward responsiveness Reward processes are shown to induce positive or pleasurable experiences Specifically there might be a strong association between the presence of anhedonia in depressed patients and dysfunction of the reward system One secondary objective A of this project is to examine reward responses and sensitivity in individuals with depressive symptoms and more specifically the effect of an online intervention for depression on reward responses Finally whereas the effect of therapist support in the form of guidance during the treatment in internet-based self-help programs is well investigated the role of peer support within internet-based self-help has not yet been fully understood There is evidence suggesting that patients mutual exchange via integrated discussion forums can increase the efficacy of Internet-based treatments and could help to overcome adherence issues of Internet-based self-help programs Further secondary objectives B and C of this study are to investigate the effects of the role of peer-to-peer support using an online forum in addition to an online program and comparison between Switzerland and India
Moreover anhedonia is a core symptom of depression It is defined as a loss of pleasure or a lack of reactivity when faced with pleasurable stimuli Hedonic capacity decreases with depression such as a reduced reactivity to pleasant cues or diminished reward responsiveness Reward processes are shown to induce positive or pleasurable experiences Specifically there might be a strong association between the presence of anhedonia in depressed patients and dysfunction of the reward system One secondary objective A of this project is to examine reward responses and sensitivity in individuals with depressive symptoms and more specifically the effect of an online intervention for depression on reward responses Finally whereas the effect of therapist support in the form of guidance during the treatment in internet-based self-help programs is well investigated the role of peer support within internet-based self-help has not yet been fully understood There is evidence suggesting that patients mutual exchange via integrated discussion forums can increase the efficacy of Internet-based treatments and could help to overcome adherence issues of Internet-based self-help programs Further secondary objectives B and C of this study are to investigate the effects of the role of peer-to-peer support using an online forum in addition to an online program and comparison between Switzerland and India
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None