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Trial registered on ANZCTR


Registration number
ACTRN12614000312640
Ethics application status
Approved
Date submitted
14/03/2014
Date registered
25/03/2014
Date last updated
8/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Online-interventions against depression. Exploring predictors of treatment outcome.
Scientific title
Predictors of treatment outcome (symptom severity) for mildly to moderately depressed patients in guided self-help vs. contact-on-demand online-interventions
Secondary ID [1] 284261 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291380 0
Condition category
Condition code
Mental Health 291743 291743 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Type of intervention: Guided online-intervention.
Participants gain individualized password-protected access to an online-platform.

Duration and general information:
The intervention lasts 6 weeks. Every week a different topic relevant to depression is presented and the participants are instructed to perform cognitive-behavioral tasks in order to reduce their symptom severity. Tools on the website as well as psychoeducation help with completing these tasks.
Participants need to invest approximately 90minutes per week.

Participants receive weekly written feedback from a psychologist (personally assigned).

The task of the psychologists is to comment on participants' letters/activities and to provide further instruction. Certain parts of their feedback are standardized, others are individualized depending on the activities of the participant.

Additionally participants are able to contact a psychologist at any time if they need to via electronic mail on the website (additional contact on demand). They receive an answer within two working days.

Adherence: Login of participants is monitored. Inactive participants will automatically receive login-reminders via e-mail after 3, 7, 14 and 20 days of inactivity.

Training of psychologists: A team of psychologists is trained before the treatment starts. Training takes 3 days (8 hours each) and gives theoretical background regarding online-interventions for depression and concrete instructions as to how to use the platform and to interact with participants. Additional information on how to react in critical situations (e.g. suicidal participants online) are provided. Afterwards psychologists work on the basis of an intervention-manual. Meetings for supervision-purposes are sheduled weekly. The team of study-psychologists remains the same throughout the whole year of intervention.

Contents, aims and methods of the intervention in detail:
Week 1:
Topic: Symptoms of depression
Aim: Insight into own symptoms.
Method: Expressive writing

Week 2:
Topic: Positive activation
Aim: Insight into own behavior related to depressive symptoms, increasing own level of activity.
Method: Calendar of daily activities, diary of positive daily events

Week 3:
Topic: Lack of motivation, difficulties to perform positive activities.
Aim: Coping with difficulties, increasing own level of activity.
Method: Written coping plans in the calendar of daily activities

Week 4:
Topic: Thought processes that worsen depressive symptoms.
Aim: Insight into own thoughts related to depression; cognitive restructuring.
Method: Cognitive bias modification training

Week 5:
Topic: Distorted perceptions that worsen depressive symptoms.
Aim: Insight into own perceptions related to depression; cognitive restructuring
Method: Thought protocols

Week 6:
Topic: "Alarm signals" that indicate relapse
Aim: Developing strategies to prevent relapse, summing up own participation in program.
Method: Expressive writing
Intervention code [1] 288966 0
Treatment: Other
Comparator / control treatment
Type of intervention: Contact-on-demand online-intervention

Duration, contents and methods are the same as described above: Participants work for 6 weeks online and are provided with the same psychoeducational contents and are given the same tasks, but they do not receive individualized feedback by a psychologist.

Instead they automatically receive general weekly feedback that provides information about common problems, motivates them to continue and gives them generally-applicable instructions.

Participants are able to contact a psychologist at any time if they need to via electronic mail on the website (contact on demand). They receive an answer within two working days.

Adherence: Login of participants is monitored. Inactive participants will automatically receive login-reminders via e-mail after 3, 7, 14 and 20 days of inactivity.
Control group
Active

Outcomes
Primary outcome [1] 291678 0
Depression:
Mean Beck Depression Inventory-II score (BDI-II) and mean Patient Health Questionnaire-9 score (PHQ-9).
Timepoint [1] 291678 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [1] 307272 0
Anxiety: Mean GAD-7-score
Timepoint [1] 307272 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [2] 307273 0
Negative automatic thoughts: Mean Automatic Thoughts Questionnaire (ATQ-R) score
Timepoint [2] 307273 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [3] 307274 0
Brooding: Mean Perservative Thinking Questionnaire (PTQ) score
Timepoint [3] 307274 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [4] 307275 0
Emotional Self-Efficacy: Mean Emotional Self-Efficacy-Scale (ESWE) score
Timepoint [4] 307275 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [5] 307276 0
Social Support: Mean Berlin Social Support Scale (BSSS) score
Timepoint [5] 307276 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [6] 307277 0
Well-Being: Mean WHO-5 score
Timepoint [6] 307277 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup

Eligibility
Key inclusion criteria
German-speaking adults suffering from depression with access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Schizophrenia, schizotypal and delusional disorders (F20-F29)
Sucidal participants
Severely depressed participants
Patients in concurrent psychotherapeutic treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central radomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software using a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Different regions of Germany have been chosen for study participation in order to guarantee representativeness (eastern/western; federal states; rural/urban).

The study aim is to use structural equation modelling (SEM) in order to assess complex interactions between participants' characteristics (e.g. demographics), activities (e.g. duration of login, completed tasks) and outcomes (e.g. depressive symptoms). The large sample sizes that SEM requires can be met with this study.

The exact number of participants is set by the public health care company associated with the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
1/04/2015
Actual
1/04/2015
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
500
Accrual to date
Final
1089
Recruitment outside Australia
Country [1] 5891 0
Germany
State/province [1] 5891 0

Funding & Sponsors
Funding source category [1] 288883 0
Government body
Name [1] 288883 0
Techniker Krankenkasse (public health care provider)
Country [1] 288883 0
Germany
Primary sponsor type
University
Name
Freie Universitaet Berlin
Address
AB Klinisch-psychologische Intervention
Habelschwerdter Alle 45
14195 Berlin
Country
Germany
Secondary sponsor category [1] 287576 0
Individual
Name [1] 287576 0
Prof. Dr. Christine Knaevelsrud
Address [1] 287576 0
Freie Universitaet Berlin
AB Klinisch-psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country [1] 287576 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290712 0
Ethikkommission der Freien Universitaet Berlin
Ethics committee address [1] 290712 0
Prof. Dr. Stefan Koelsch
Vorsitzender der Ethikkommission
der Freien Universitaet Berlin
Habelschwerdter Allee 45
14195 Berlin
Ethics committee country [1] 290712 0
Germany
Date submitted for ethics approval [1] 290712 0
12/12/2013
Approval date [1] 290712 0
20/02/2014
Ethics approval number [1] 290712 0

Summary
Brief summary
Background:
Psychological treatments via the internet have proven effective and applicable for a number of mental-health issues such as anxiety, eating disorders and depression. However meta-analysis of internet-intervention-studies show that effects are better, when they are aimed at reducing anxiety than depressive symptoms. Yet knowledge about how and why these interventions work and for whom they work best is still scarce.
A central variable that predicts treatment effectiveness in depression is the amount of client-psychologist-contact. The study at hand seeks to increase knowledge about mechanisms of effectiveness in online-interventions against depression with special focus on the relationship between clients and psychologists.


Intervention:
Depressed participants are allocated at random to a cognitive-behavioral online-intervention with regular weekly contact to a psychologist (guided intervention) or with contact-on-demand only (i.e. having to explicitly ask for contact).
Over the course of 6 weeks both groups receive psychoeducational information about their symptoms and different tasks in order to reduce them (e.g. positive activation, cognitive restructuring, emotional insight).
Engaging tools on the website help participants with the completion of these tasks. While the guided group receives weekly individualized feedback, the contact-on-demand group automatically receives standardized feedback that contains general instructions and motivates participants to continue with the intervention.


Method:
Both groups are compared with regard to therapeutic outcomes (e.g. depressive symptoms) and predictors of treatment-success (e.g. adherence to treatment, social support, perceived quality of relationship to the psychologist).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46922 0
Prof Christine Knaevelsrud
Address 46922 0
Freie Universitaet Berlin
AB Klinisch-psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country 46922 0
Germany
Phone 46922 0
+49 - (0) 30 - 83855736
Fax 46922 0
Email 46922 0
[email protected]
Contact person for public queries
Name 46923 0
Prof Christine Knaevelsrud
Address 46923 0
Freie Universitaet Berlin
AB Klinisch-psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country 46923 0
Germany
Phone 46923 0
+49 - (0) 30 - 83855736
Fax 46923 0
Email 46923 0
[email protected]
Contact person for scientific queries
Name 46924 0
Prof Christine Knaevelsrud
Address 46924 0
Freie Universitaet Berlin
AB Klinisch-psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country 46924 0
Germany
Phone 46924 0
+49 - (0) 30 - 83855736
Fax 46924 0
Email 46924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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