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Trial registered on ANZCTR


Registration number
ACTRN12616001521415
Ethics application status
Approved
Date submitted
20/10/2016
Date registered
4/11/2016
Date last updated
4/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Online-interventions against depression for adults. Does the ordering of treatment components matter for symptom improvements?
Scientific title
Does ordering matter? The effect of counterbalancing behavioral activation and cognitive restructuring in a guided self-help online-intervention for depressed individuals.
Secondary ID [1] 290227 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 300413 0
Condition category
Condition code
Mental Health 300272 300272 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Guided online-intervention.

Duration and general information:

The intervention lasts 6 weeks. Participants need to invest approximately 90 minutes per week/module. The modules are completed over multiple (two to seven) shorter sessions per week, depending on the task at hand and on participant's preferences. 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. All treatment content (psychoeducational content as well as specific treatment tools) is delivered online. Participants gain individualized password-protected access to an online-platform.

Participants receive weekly written feedback via e(lectronic)-mail from a trained psychologist (personally assigned; psychologist with at least finished itermediate examination of their psycho-therapeutic training). Psychologists comment on participants' letters/activities/tool usage and to provide further instructions as well as emotional support. Psychologists are provided with standardized text blocks, which are completed by individualized feedback lines.

Participants are able to contact a psychologist at any time if they need to via e-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 to increase adherence.

Participants are guided by a team of psychologist trained in the use of online-interventions.
The treatment-specific training of psychologists takes 3 days (8 hours each) and gives theoretical background regarding online-interventions for depression and concrete instructions on how to use the platform and to interact with participants. Additional information on how to react in critical situations (e.g. suicidal participants online) is provided. An intervention manual is provided to ensure the psychologists adherence to the treatment. Meetings for supervision-purposes are scheduled monthly. Both an researching psychologist on the area of online interventions and a licensed psychotherapist provide the training as well as the supervision.

Contents, aims and methods of the intervention in detail:
The RCT contains two treatment arms (Arm 1: BAF - Behavioral Activation First; Arm 2: Cognitive Restructuring First - CRF) . Both arms contain the same treatment modules, e.g. the same psychoeducational content as well as the same treatment techniques. Both treatment arms differ in the ordering of behavioral activation and cognitive restructuring techniques (see control condition).

Arm 1: BAF – ordering of provided treatment modules:

Insight in depressive symptoms (Week 1)
Topic: Symptoms of depression
Aim: Insight into own symptoms.
Method: Expressive writing

Behavioral activation I (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

Behavioral activation II (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

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

Cognitive Restructuring II (Week 5)
Topic: Distorted perceptions that worsen depressive symptoms.
Aim: Insight into own perceptions related to depression; cognitive restructuring
Method: Cognitive bias modification training and thought protocols

Relapse prevention (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] 296002 0
Behaviour
Intervention code [2] 296310 0
Treatment: Other
Comparator / control treatment
Duration, contents, methods, adherence monitoring, contact possibilities and training of described above and identical over conditions. Participants work for 6 weeks online and are provided with the same psychoeducational contents and are given the same tasks, but the ordering of behavioral activation techniques and cognitive restructuring is changed:


Arm 2: CRF – ordering of provided treatment modules:

Insight in depressive symptoms (Week 1)
Cognitive Restructuring I (Week 2)
Cognitive Restructuring II (Week 3)
Behavioral activation I (Week 4)
Behavioral activation II (Week 5)
Relapse prevention (Week 6)
Control group
Active

Outcomes
Primary outcome [1] 299750 0
Depression: mean Beck Depression Inventory-II score (BDI-II)
Timepoint [1] 299750 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Primary outcome [2] 299753 0
Depression: mean Patient Health Questionnaire-9 score (PHQ-9).
Timepoint [2] 299753 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
Within treatment (immediatly before starting week 1, 2, 3, 4, 5 and 6)
3-months followup
6-months followup
12-months followup
Secondary outcome [1] 328001 0
Anxiety: mean Generalized Anxiety Disorder 7 item scale score (GAD-7)
Timepoint [1] 328001 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] 328002 0
Cognitive Bias: mean Cognitive Styles Assessment score (COSTA-21)
Timepoint [2] 328002 0
Pre-Treatment (immediately before start of treatment)
Within treatment (immediatly before starting week 2 and 4)
Post-Treatment (immediately after completion of treatment)
3-months followup
6-months followup
12-months followup
Secondary outcome [3] 328003 0
Self-Efficacy: mean General Perceived Self-Efficacy Scale score (GPSE)
Timepoint [3] 328003 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] 328004 0
Social Support: mean Berlin Social Support Scale score (BSSS)
Timepoint [4] 328004 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] 328005 0
Participation: mean “Index zur Messung von Einschränkungen der Teilhabe [Index of barriers of participation]” score (IMET)
Timepoint [5] 328005 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] 328006 0
Well-Being: mean WHO-5 score
Timepoint [6] 328006 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
Secondary outcome [7] 328026 0
Well-Being: mean EUROHIS_QOL score
Timepoint [7] 328026 0
Pre-Treatment (immediately before start of treatment)
Post-Treatment (immediately after completion of treatment)
Secondary outcome [8] 328027 0
Theapy evaluation: mean Questionnaire on Therapy Expectation and Evaluation (PATHEV) score
Timepoint [8] 328027 0
Pre-Treatment (immediately before start of treatment)
Secondary outcome [9] 328028 0
Perceived Stress: mean Patient Health Questionnaire stress module (PHQ-S) score
Timepoint [9] 328028 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 [10] 328029 0
Illness-Perception: mean Illness Perceptions Questionnaire-Revised (IPQ-R) score
Timepoint [10] 328029 0
Pre-Treatment (immediately before start of treatment)
Secondary outcome [11] 328030 0
Therapy Expectations: 3 items from the EUHEALS questionnaire
(expectation of efficacy, perceived usefullnes of approach, recommend to a friend)
Timepoint [11] 328030 0
Pre-Treatment (immediately before start of treatment)
Secondary outcome [12] 328031 0
Values: mean Perceived Values Questionnaire (PVQ) score
Timepoint [12] 328031 0
Pre-Treatment (immediately before start of treatment)
Secondary outcome [13] 328032 0
Change Mechanisms: mean Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP) subscale scores (mastery, resource avtivation, emotional bond, problem actuation, clarification of meaning, agreement on collaboration)
Timepoint [13] 328032 0
Within treatment (immediatly before starting week 2 and 4)
Post-Treatment (immediately after completion of treatment)
Secondary outcome [14] 328033 0
adverse events during treatment and effect on well-beeing, 7 items
* general occurance of adverse events
* open question: description of adverse event
* time-point of occurance
* relation between adverse event and specific treatment techniques
* influece on well being at time-point of occurance
* current influence on well-being
* reporting of adverse event to coach
Timepoint [14] 328033 0
Post-Treatment (immediately after completion of treatment)

Eligibility
Key inclusion criteria
German-speaking adults suffering from depression with access to the internet
Minimum age
18 Years
Maximum age
No limit
Gender
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
Participants of both treatment arms receive the same treatment modules, however, the ordering of behavioral activation and cognitive restructuring differs between both treatment arms [Arm 1: Expressive Writing – behavioral activation – cognitive restructuring – expressive writing; Arm 2: Expressive Writing – cognitive restructuring – behavioral activation – expressive writing]
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8266 0
Germany
State/province [1] 8266 0
all federal states

Funding & Sponsors
Funding source category [1] 294589 0
Government body
Name [1] 294589 0
Techniker Krankenkasse (public health care provider)
Address [1] 294589 0
Bramfelder Str. 140
22305 Hamburg
Country [1] 294589 0
Germany
Primary sponsor type
University
Name
Freie Universitaet Berlin
Address
Freie Universitaet Berlin
AB Klinisch-Psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country
Germany
Secondary sponsor category [1] 293457 0
Individual
Name [1] 293457 0
Christine Knaevelsrud
Address [1] 293457 0
Freie Universitaet Berlin
AB Klinisch-Psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country [1] 293457 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296030 0
Ethikkommission der Freien Universitaet Berlin
Ethics committee address [1] 296030 0
Prof. Dr. Annette Kinder
Vorsitzende der Ethikkommission
der Freien Universitaet Berlin
Habelschwerdter Allee 45
14195 Berlin
Ethics committee country [1] 296030 0
Germany
Date submitted for ethics approval [1] 296030 0
26/09/2016
Approval date [1] 296030 0
12/10/2016
Ethics approval number [1] 296030 0
125 /2016

Summary
Brief summary
Background:
Psychological treatments via the internet have proven effective in reducing depressive symptom complaints. A first evlaluation of the provided treatment programm yielded large pre-post-effects on depression, anxiety, perseverative thinking, and well-being. However, little is known about the influence of temporal ordering of provided treatment modules on symptom improvements, patterns of change, treatment adherence and if different groups of individuals are affected differently. Therefore, systematic evaluations of temporal ordering effects are necessary to gain deeper insight into which treatment components are the most critical ingredients for successful online interventions for depression.

Intervention:
Depressed participants are allocated at random to a two-armed cognitive-behavioral online-intervention with regular weekly contact to a psychologist (guided intervention). The two treatment arms differ in the ordering of provided treatment modules [Arm 1: Expressive Writing – behavioral activation – cognitive restructuring – expressive writing; Arm 2: Expressive Writing – cognitive restructuring – behavioral activation – expressive writing]. Both treatment arms receive the same psychoeducational information about their symptoms and treatment modules to reduce depressive complaints (e.g. positive activation, cognitive restructuring, emotional insight). Engaging tools on the website help participants with the completion of these tasks.

Method:
Both groups are compared with regard to therapeutic outcomes (e.g. depressive symptoms), the influence of the ordering of provided treatment modules on symptom change and adherence, as well as predictors of treatment-success.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1190 1190 0 0

Contacts
Principal investigator
Name 69302 0
Prof Christine Knaevelsrud
Address 69302 0
Freie Universitaet Berlin
AB Klinisch-Psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country 69302 0
Germany
Phone 69302 0
+49 - (0)30 838 - 55736
Fax 69302 0
Email 69302 0
christine.knaevelsrud@fu-berlin.de
Contact person for public queries
Name 69303 0
Prof Christine Knaevelsrud
Address 69303 0
Freie Universitaet Berlin
AB Klinisch-Psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country 69303 0
Germany
Phone 69303 0
+49 - (0)30 838 - 55736
Fax 69303 0
Email 69303 0
christine.knaevelsrud@fu-berlin.de
Contact person for scientific queries
Name 69304 0
Prof Christine Knaevelsrud
Address 69304 0
Freie Universitaet Berlin
AB Klinisch-Psychologische Intervention
Habelschwerdter Allee 45
14195 Berlin
Country 69304 0
Germany
Phone 69304 0
+49 - (0)30 838 - 55736
Fax 69304 0
Email 69304 0
christine.knaevelsrud@fu-berlin.de

No information has been provided regarding IPD availability
Summary results
No Results