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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Condition category

Condition code

Mental Health

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]

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]

Depression:
Mean Beck Depression Inventory-II score (BDI-II) and mean Patient Health Questionnaire-9 score (PHQ-9).

Timepoint [1]