Depressive SymptomsNCT04551794
Different Levels of Guidance in iCBT for Depression (RCT)
A study testing Selfapy with therapeutic guidance and Selfapy with additional peer support in people with Depressive Symptoms and Quality of Life, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms, Quality of Life, Self Esteem
- What is being tested?
- Selfapy with therapeutic guidance and Selfapy with additional peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2016to 9 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective psychological distress caused by depressive symptoms, wish for treatment, access to Internet, sufficient knowledge of the German language.
Who cannot join
- Acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: iCBT for Depression: A Randomized Controlled Trial Comparing Different Levels of Guidance
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions. The groups were organized into one wait-list control group and two groups receiving access to Selfapy with different levels of guidance.
Read the detailed description
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The primary outcome is the PHQ-9 as a measure of the severity of depressive symptoms, combined with the BDI-II. Secondary outcomes are rates of quality of life and satisfaction with the program, which were measured with the WHOQOL-BREF and ZUF-8. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions over the course of three months. The groups were organized into one wait-list control group, one that received Selfapy with additional peer support and one that received Selfapy with therapeutic guidance.The wait-list control group received access to the program after completion of the post-survey.
- Conditions
- Depressive Symptoms, Quality of Life, Self Esteem
- Being tested
- Selfapy with therapeutic guidance, Selfapy with additional peer support
- Keywords
- Depressive symptoms, iCBT, guidance, peer-support, RCT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selfapy with therapeutic guidanceBehavioural
The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences with a therapeutic guide.
Selfapy with additional peer supportBehavioural
The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum.
| Study group | Role | What they receive |
|---|---|---|
| Online self-help program with additional peer support | Experimental | The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum. Receives: Behavioral: Selfapy with additional peer support |
| No intervention: waitlist-control group | No intervention | The participants of the wait-list control condition do not receive any new intervention during the intervention period of 9 weeks, but may continue any treatment that has already been started before, including medication. Participants in the wait-list control condition receive full access to the program after completion of the post-assessment. |
| Online self-help program with therapeutic guidance | Experimental | The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences and difficulties concerning the program on a weekly basis with a therapeutic guide on the phone. Receives: Behavioral: Selfapy with therapeutic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)
The PHQ-9 (Kroenke et al. 2001) is made up of 9 items which could be self-rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Major depression and other depression diagnoses according to DSM-IV can be determined according to the overall score. Sum scores of 0-4 indicate none or minimal depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, and 15-27 severe depressive symptoms. Its internal consistency ranges from 0.86-0.89 (Smarr and Keefer 2011).
Measured: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
Change in depression measured with Beck Depression Inventory (BDI-II)
The BDI-II (Beck et al., 1996) is a 21-item self-report inventory measuring the severity of depression in adolescents and adults. Each item is rated on a four-point Likert scale ranging from 0 (symptom not present) to 3 (symptom very intense). The BDI assesses psychological and physical symptoms over the last two weeks in order to quantify levels of depression. An overall score of 0-13 indicates minimal depression, a score of 14-19 indicates mild depression, a score of 20-28 moderate depression and total scores of 29-63 suggest severe depression. The internal consistency of the BDI-II ranges from 0.79-0.90 (Smarr and Keefer 2011).
Measured: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
Secondary outcomes (2)
Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)
The WHOQOL-BREF is a shorter version of the World Health Organization Quality of Life-100 (The WHOQOL Group 1998). It is composed of 26 self-report items measuring domains such as physical health, psychological health, social relationships and environment with the aim of measuring changes in quality of life over the course of treatment. Four different types of 5-point Likert scales are applied, asking "how much", "how complete", "how often", "how good" or "how satisfied" the person felt concerning the past two weeks. The WHOQOL-BREF has an internal consistency of .70 (Skevington, Lotfy, \& O'Connell, 2004).
Measured: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8)
The German version of the Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8; Schmidt, Lamprecht, \& Wittmann, 1989) is a self-report inventory that measures client satisfaction concerning the received treatment during inpatient stays. Each item could be answered on a 4-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree). The internal consistency of the ZUF-8 ranges between 0.87-0.93 (Brähler, Schumacher, \& Strauß, 2002).
Measured: Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start15 Aug 2016
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled study with three conditions: Condition 1: Online intervention with therapeutic guidance (telephone contacts). Condition 2: Online intervention with additional peer support (online forum). Condition 3: Wait-list control group (access to the online intervention after completion of the post-assessment). Two assessments-points, the intervention period (pre-post) is three months. At both assessments psychopathological data are obtained via the Internet survey Enterprise Feedback Suite survey by QuestBack Unipark®.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffen Moritz, Prof., Principal investigator, University Medical Center Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551794
- Sponsor's protocol ID
- Selfapy
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCBT for Depression: A Randomized Controlled Trial Comparing Different Levels of Guidance
- ClinicalTrials.gov ID
- NCT04551794
- Acronym / sponsor ID
- Selfapy
- Conditions
- Depressive Symptoms, Quality of Life, Self Esteem
- Keywords
- Depressive symptoms, iCBT, guidance, peer-support, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions. The groups were organized into one wait-list control group and two groups receiving access to Selfapy with different levels of guidance.
Detailed description
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The primary outcome is the PHQ-9 as a measure of the severity of depressive symptoms, combined with the BDI-II. Secondary outcomes are rates of quality of life and satisfaction with the program, which were measured with the WHOQOL-BREF and ZUF-8. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions over the course of three months. The groups were organized into one wait-list control group, one that received Selfapy with additional peer support and one that received Selfapy with therapeutic guidance.The wait-list control group received access to the program after completion of the post-survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study is a randomized controlled study with three conditions: Condition 1: Online intervention with therapeutic guidance (telephone contacts). Condition 2: Online intervention with additional peer support (online forum). Condition 3: Wait-list control group (access to the online intervention after completion of the post-assessment). Two assessments-points, the intervention period (pre-post) is three months. At both assessments psychopathological data are obtained via the Internet survey Enterprise Feedback Suite survey by QuestBack Unipark®.
| Arm | Type | Receives |
|---|---|---|
| Online self-help program with additional peer support | Experimental | Behavioral: Selfapy with additional peer supportThe intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum. |
| No intervention: waitlist-control group | No intervention | –The participants of the wait-list control condition do not receive any new intervention during the intervention period of 9 weeks, but may continue any treatment that has already been started before, including medication. Participants in the wait-list control condition receive full access to the program after completion of the post-assessment. |
| Online self-help program with therapeutic guidance | Experimental | Behavioral: Selfapy with therapeutic guidanceThe intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences and difficulties concerning the program on a weekly basis with a therapeutic guide on the phone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjective psychological distress caused by depressive symptoms, wish for treatment, access to Internet, sufficient knowledge of the German language.
Key exclusion criteria (1 listed)
- Acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selfapy with therapeutic guidanceThe program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences with a therapeutic guide. | Behavioural | Online self-help program with therapeutic guidance |
| Selfapy with additional peer supportThe program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum. | Behavioural | Online self-help program with additional peer support |
Primary outcome
Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)
Time frame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
The PHQ-9 (Kroenke et al. 2001) is made up of 9 items which could be self-rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Major depression and other depression diagnoses according to DSM-IV can be determined according to the overall score. Sum scores of 0-4 indicate none or minimal depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, and 15-27 severe depressive symptoms. Its internal consistency ranges from 0.86-0.89 (Smarr and Keefer 2011).
Change in depression measured with Beck Depression Inventory (BDI-II)
Time frame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
The BDI-II (Beck et al., 1996) is a 21-item self-report inventory measuring the severity of depression in adolescents and adults. Each item is rated on a four-point Likert scale ranging from 0 (symptom not present) to 3 (symptom very intense). The BDI assesses psychological and physical symptoms over the last two weeks in order to quantify levels of depression. An overall score of 0-13 indicates minimal depression, a score of 14-19 indicates mild depression, a score of 20-28 moderate depression and total scores of 29-63 suggest severe depression. The internal consistency of the BDI-II ranges from 0.79-0.90 (Smarr and Keefer 2011).
2 secondary outcomes
Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)
Time frame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8)
Time frame: Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Moritz, Prof. principal investigator
University Medical Center Hamburg-Eppendorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selfapy with therapeutic guidance and Selfapy with additional peer support in people with Depressive Symptoms and Quality of Life, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9) (time frame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.