Information technology in the out-patient care of adolescents with depression

ISRCTN	ISRCTN80379583
DOI	https://doi.org/10.1186/ISRCTN80379583
Protocol serial number	214245
Sponsor	Academy of Finland (Finland)
Funders	Academy of Finland (Finland) (ref: 214245), The Hospital District of Southwest Finland (Finland) (ref: EVO 13893)

Submission date: 21/12/2009
Registration date: 07/01/2010
Last edited: 08/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maritta Välimäki
Scientific

Department of Nursing Science
Turku
20014
Finland

Phone	+358 (0)2 333 8495
Email	mava@utu.fi

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled two armed trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of information technology in the out-patient care of adolescents with depression: a multicentre randomised controlled trial with two arms
Study acronym	Depis.Net
Study objectives	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(s)	The Ethics Committee of the Pirkanmaa Hospital District (Science Center) approved on the 8th October 2008 (ref: R08075H)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Depressive symptoms: BDI-21. Data collection will take 12 months at four points: baseline, and 3, 6, and 12 months follow-up from baseline.
Key secondary outcome measure(s)	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)
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	15 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	300
Key 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
Key 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
Date of first enrolment	17/11/2008
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

Finland

Study participating centre

Department of Nursing Science

Turku
20014
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes