Psychiatric DiseasesPhase 2/3AdolInpRehabiNCT01709526
How the Adolescent Inpatients Are Rehabilitated After Discharge
A Phase 2/3 study testing Improvement after psychiatric inpatient treatment in people with Psychiatric Diseases, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The aims of this six month follow-up study are which treatment components will correlate or which clinical treatments interventions contribute adolescent inpatients recovering in the psychiatric treatment after discharge. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Psychiatric Diseases
- What is being tested?
- Improvement after psychiatric inpatient treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Oct 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- psychiatric disease
- adolescents
- inpatient treatment
Who cannot join
- emergency psychiatric treatment
- under 4 weeks treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study the Adolescent Inpatients Rehabilitation
The aims of this six month follow-up study are which treatment components will correlate or which clinical treatments interventions contribute adolescent inpatients recovering in the psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents aged 13 to 18 years, with major depression and conduct disorders, and between those with and without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients recovered?
Read the detailed description
The whole prospective study sample consisted of 63 adolescents aged 13 to 18 years (40 girls and 23 boys)referred for psychiatric treatment to the adolescent psychiatric inpatient unit of Kuopio University Hospital, Finland. This study is part of the "Kliininen Laatuprojekti"- Depression Project in Kuopio University Hospital. Researcher UH, Doctor of Philosophy, has been the head of the study project. She has done this study by carrying, analysing, doing articles and writing abstracts and keeping lectures and congress sessions in Finland and aboard. In the same time she has done clinical work by caring adolescents in the hospital ward and in the therapy settings. UH has been the first writer in the articles, one article in national and three in international articles. This Doctoral dissertation has been presented 17th November 2007, supervisor was professor, MD. Mauri Marttunen.
The prospective study set out to investigate gender differences, psychosocial and cognitive functioning, self-image, and changes in these structured parameters, and the role of working alliance. More girls than boys were admitted to inpatient care. Mood and conduct disorders were the most common diagnoses. Girls more commonly had poor family relationships but more peers than boys. Violent and destructive behaviour were more common among boys, and they performed worse in tests assessing nonverbal cognitive performance and total immediate recall memory than girls. Both girls and boys had an impaired IQ at entry. Major impairment in functioning in several areas such as school, family relations, judgement and thinking was found among both genders.
The psychosocial functioning and cognitive performance of inpatients improved during treatment.
There were also improvements in intrapsychic constructs: in the psychological self-image, especially body-image, and in relationships with family members, particularly among emotionally-disturbed adolescents. Cognitive performance was significantly enhanced among subjects both with a good and with a poor working alliance. According to multivariate analyses, a better quality of working alliance and a greater number of therapy sessions were associated with positive changes in cognitive performance and self-image.
When subjects with major depression and conduct disorder were compared, nonverbal cognitive and general cognitive performance, body and self-image, and overall psychosocial functioning improved in both groups of subjects during treatment. More positive changes in self-image and family functioning were found among subjects with MDD.
Suicidal adolescents' treatment compliance and outcome were as good as those of non-suicidal patients. Their psychosocial functioning, cognitive performance, and both the psychological self and body-image improved during treatment. Positive changes in body-image associated significantly with a higher probability of improvement in psychosocial functioning, while a higher GAS score at entry was associated with a lower probability of functional improvement. In clinical practice, attention needs to be paid to structured assessment of adolescent psychiatric inpatients. This study suggests a need to combine at least regular individual therapy, pharmacotherapy, family interventions, and a school program. Since a good working alliance between the therapist and the adolescent patient seems to modify the treatment outcome, particular attention to creating a good alliance with the patient and intensive involvement of the parents in treatment are recommended. Prospective studies with a sufficient follow-up after discharge and well-designed intervention studies among adolescent inpatients are needed.
Now it is interested in how they are in recovery with the role of working alliance and improvement in the psychosocial functioning after discharge?
- Conditions
- Psychiatric Diseases
- Being tested
- Improvement after psychiatric inpatient treatment
- Keywords
- Psychosocial functioning, Cognitive performance of inpatients, Psychiatric diseases
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvement after psychiatric inpatient treatmentBehavioural
Also called After adolescents treatment
Cognition, psychosocial functioning
| Study group | Role | What they receive |
|---|---|---|
| Improvement after psychiatric inpatient treatment | Other | Not described Receives: Behavioral: Improvement after psychiatric inpatient treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Study couldn´t start due to investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Principal investigator, Helena Pehkonen, Kuopio University Hospital
- Investigators
- Ulla Hintikka, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709526
- Sponsor's protocol ID
- KUH5702803
- Other IDs
- KUH5702803
- Acronym
- AdolInpRehabi
- Status last verified
- Oct 2012
- First submitted
- 29 Jun 2011
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study the Adolescent Inpatients Rehabilitation
- ClinicalTrials.gov ID
- NCT01709526
- Acronym / sponsor ID
- AdolInpRehabi / KUH5702803
- Conditions
- Psychiatric Diseases
- Keywords
- Psychosocial functioning, Cognitive performance of inpatients, Psychiatric diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study couldn´t start due to investigator
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this six month follow-up study are which treatment components will correlate or which clinical treatments interventions contribute adolescent inpatients recovering in the psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents aged 13 to 18 years, with major depression and conduct disorders, and between those with and without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients recovered?
Detailed description
The whole prospective study sample consisted of 63 adolescents aged 13 to 18 years (40 girls and 23 boys)referred for psychiatric treatment to the adolescent psychiatric inpatient unit of Kuopio University Hospital, Finland. This study is part of the "Kliininen Laatuprojekti"- Depression Project in Kuopio University Hospital. Researcher UH, Doctor of Philosophy, has been the head of the study project. She has done this study by carrying, analysing, doing articles and writing abstracts and keeping lectures and congress sessions in Finland and aboard. In the same time she has done clinical work by caring adolescents in the hospital ward and in the therapy settings. UH has been the first writer in the articles, one article in national and three in international articles. This Doctoral dissertation has been presented 17th November 2007, supervisor was professor, MD. Mauri Marttunen.
The prospective study set out to investigate gender differences, psychosocial and cognitive functioning, self-image, and changes in these structured parameters, and the role of working alliance. More girls than boys were admitted to inpatient care. Mood and conduct disorders were the most common diagnoses. Girls more commonly had poor family relationships but more peers than boys. Violent and destructive behaviour were more common among boys, and they performed worse in tests assessing nonverbal cognitive performance and total immediate recall memory than girls. Both girls and boys had an impaired IQ at entry. Major impairment in functioning in several areas such as school, family relations, judgement and thinking was found among both genders.
The psychosocial functioning and cognitive performance of inpatients improved during treatment.
There were also improvements in intrapsychic constructs: in the psychological self-image, especially body-image, and in relationships with family members, particularly among emotionally-disturbed adolescents. Cognitive performance was significantly enhanced among subjects both with a good and with a poor working alliance. According to multivariate analyses, a better quality of working alliance and a greater number of therapy sessions were associated with positive changes in cognitive performance and self-image.
When subjects with major depression and conduct disorder were compared, nonverbal cognitive and general cognitive performance, body and self-image, and overall psychosocial functioning improved in both groups of subjects during treatment. More positive changes in self-image and family functioning were found among subjects with MDD.
Suicidal adolescents' treatment compliance and outcome were as good as those of non-suicidal patients. Their psychosocial functioning, cognitive performance, and both the psychological self and body-image improved during treatment. Positive changes in body-image associated significantly with a higher probability of improvement in psychosocial functioning, while a higher GAS score at entry was associated with a lower probability of functional improvement. In clinical practice, attention needs to be paid to structured assessment of adolescent psychiatric inpatients. This study suggests a need to combine at least regular individual therapy, pharmacotherapy, family interventions, and a school program. Since a good working alliance between the therapist and the adolescent patient seems to modify the treatment outcome, particular attention to creating a good alliance with the patient and intensive involvement of the parents in treatment are recommended. Prospective studies with a sufficient follow-up after discharge and well-designed intervention studies among adolescent inpatients are needed.
Now it is interested in how they are in recovery with the role of working alliance and improvement in the psychosocial functioning after discharge?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improvement after psychiatric inpatient treatment | Other | Behavioral: Improvement after psychiatric inpatient treatment |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- psychiatric disease
- adolescents
- inpatient treatment
Key exclusion criteria (2 listed)
- emergency psychiatric treatment
- under 4 weeks treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvement after psychiatric inpatient treatmentAlso: After adolescents treatmentCognition, psychosocial functioning | Behavioural | Improvement after psychiatric inpatient treatment |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study couldn´t start due to investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Hintikka principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Improvement after psychiatric inpatient treatment in people with Psychiatric Diseases, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study couldn´t start due to investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.