Condition category
Mental and Behavioural Disorders
Date applied
21/12/2009
Date assigned
07/01/2010
Last edited
08/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.med.utu.fi/hoitotiede/depisnet.html

Contact information

Type

Scientific

Primary contact

Prof Maritta Välimäki

ORCID ID

Contact details

Department of Nursing Science
Turku
20014
Finland
+358 (0)2 333 8495
mava@utu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

214245

Study information

Scientific title

Evaluation of information technology in the out-patient care of adolescents with depression: a multicentre randomised controlled trial with two arms

Acronym

Depis.Net

Study hypothesis

1. Information technology (IT) use in out-patient care decreases depressive symptoms and behaviour disorders, increases psychosocial functioning, knowledge level about mental problems, and quality of life in adolescents more effectively than traditional care.
2. IT use in out-patient care is cost-effective compared to traditional care in terms of having lower health care costs and less depressive symptoms.

Ethics approval

The Ethics Committee of the Pirkanmaa Hospital District (Science Center) approved on the 8th October 2008 (ref: R08075H)

Study design

Multicentre randomised controlled two armed trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression, out-patient care

Intervention

Intervention group:
Adolescents in intervention group participate to one face-to-face session with researcher where they receive information on intervention, username and password to Depis.Net e-learning platform. Depis.Net -platform includes five (5) informational topic: well-being; family life; treatment of depression; adolescents' depression and adolescents' rights and duties. In addition, Depis.Net -platform includes reflective diary, question corner, BDI-21 questionnaire, reflective questions, network map, and schedule to keep track on sleeping. During five week period adolescents use Depis.Net independently. Each week they have certain informational topic and they work at the platform. In the beginning of new topic adolescents receive individual feedback via Depis.Net and a text-message about the new topic to begin. After five week period adolescents give their feedback of Depis.Net at the platform. Professionals in out-patient clinics discuss with adolescents about the topics based on adolescents' individual needs. In addition, adolescents in intervention group receive standard care with face-to-face sessions with staff.

Control group:
Adolescents in control group, ('treatment as usual') receive standard care with face-to-face sessions with staff.

Total duration of treatment: 5 weeks
Total duration of follow-up: 1 year; baseline, follow up at 3, 6 and 12 month.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Depressive symptoms: BDI-21. Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.

Secondary outcome measures

1. Behaviour disorders: The Strengths and Difficulties Questionnaire (SDQ). Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.
2. Psychosocial functioning; data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline:
2.1. The Global Assessment Scale (cGAS)
2.2. Clinical Global Impressions (CGI)
Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.
3. Knowledge about illness and treatment: Knowledge test (ADKQ). Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.
4. Satisfaction with treatment: ADTSQ. Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.
5. Quality of Life: PQ-LES-Q. Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.
6. Costs: Client Services Receipt Inventory (CSRI): questions concerning use of health care resources for a retrospective period of 3 months (administered at baseline and 12 month follow-up only)

Overall trial start date

17/11/2008

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents contacting psychiatric out-patient clinics at study hospitals
2. Aged 15 - 17 years, either sex
3. Ability to read, write and speak Finnish
4. Voluntary participation and written consent form

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300, 150 for both arms

Participant exclusion criteria

1. Psychotic depression, bipolar disorder, substance abuse
2. Admission to psychiatric in-patient care
3. No depressive symptoms (21-item Beck Depression Inventory [BDI-21] = 10 or under 10)
4. Less than three therapy sessions planned

Recruitment start date

17/11/2008

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Finland

Trial participating centre

Department of Nursing Science
Turku
20014
Finland

Sponsor information

Organisation

Academy of Finland (Finland)

Sponsor details

Vilhonvuorenkatu 6
PL 99
Helsinki
00501
Finland

Sponsor type

Research organisation

Website

http://www.aka.fi/en-gb/A/

Funders

Funder type

Research organisation

Funder name

Academy of Finland (Finland) (ref: 214245)

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

Funder name

The Hospital District of Southwest Finland (Finland) (ref: EVO 13893)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes