Drug AddictionNCT01891045
Impact of Online Patient Feedback (OQ) to Therapist
A study testing OQ-45.2 no feedback and OQ-45.2 in people with Drug Addiction and Drug Abuse, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Dropout represents one of the largest problems in substance abuse treatment. International and Nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. At the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. Read more about this study
- Who is it for?
- Ages 16 to 26 years
- Conditions the study is for
- Drug Addiction, Drug Abuse
- What is being tested?
- OQ-45.2 no feedback and OQ-45.2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jul 2011to 3 Jan 2023
- Phase
- Interventional
- 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 16 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of addiction, F10-19, using the International Classification of Diseases, admitted in 2011-2014 for treatment at the department of addiction treatment - youth, Oslo University Hospital
Who cannot join
- Ongoing psychoses, severe language difficulties
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of addiction treatment- youth
Oslo, 0514
Oslo University Hospital - Department of addiction treatment youth
Oslo, 0514
About this study
Official title: Addiction Treatment Dropout Prevention - Impact of Online Patient Feedback (OQ-45.2) to Therapist
Dropout represents one of the largest problems in substance abuse treatment. International and Nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. At the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. In spite of the serious and continuous challenge dropout represents the phenomena is not well understood and there is a need to explore more of the factors that influence dropout and how it can be counteracted. As also stated: "…effective methods for reducing the problem of dropouts from treatment is one more area in need of further research" (NOU 2003:4, s 77).
For the general field of mental health one of the most important innovations involves providing therapists with patient feedback about their progress. The most well-established and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has been shown to improve treatment outcomes, including reduced treatment dropout and length of treatment, but the system is yet to be utilized with a substance abusing patient group. The aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing patients.
Read the detailed description
Hypotheses and research questions
- The OQ-45.2 feedback will be effective in identifying patients at risk of dropout of substance abuse treatment.
1a. The condition were feedback is withheld from the therapist, will correctly identify patients who will dropout.
Research Question: Is there variation in the accuracy of dropout prediction as a function of age, gender differences or type of substance abuse?
- The OQ-45.2 feedback will be effective in reducing dropout in outpatient substance abuse treatment.
2a. The feedback condition will result in less dropout than the no-feedback condition.
Research Question: Is there a variation in the OQ-45.2 preventive dropout effect due to age, gender or type of substance abuse?
- The OQ-45.2 feedback will shorten length of inpatient substance abuse treatment.
3a. The feedback condition will identify patients who are ready to terminate therapy.
Research Question: Is there variation in identification of patients ready to terminate as a function of age, gender differences or type of substance abuse?
- Conditions
- Drug Addiction, Drug Abuse
- Being tested
- OQ-45.2 no feedback, OQ-45.2
- Keywords
- Psychotherapy, Drug addiction, Drop-out, OQ-45.2, Clinical trial, Randomized Controlled Trail
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OQ-45.2 no feedbackBehavioural
Completion of the OQ-45.2 before each session, but no feedback to therapists or patients
OQ-45.2Behavioural
Completion of the OQ-45.2 with real-time feedback to the therapist and full use of the suggested interventions every week of the treatment program
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients merely monitored on background variables to function as a baseline of comparison |
| Prediction | Active comparator | Patients randomized to this condition completes the OQ-45.2 weekly, but the reports are withheld from therapists and patients. Receives: Behavioral: OQ-45.2 no feedback |
| Intervention | Experimental | Patients and therapists uses the feedback-system as intended, with real-time feedback to the therapist and full use of the suggested interventions Receives: Behavioral: OQ-45.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop-out from residential SUD treatment
Exit reason from residential Substance Use Disorder treatment (Drop-out or completed as planned)
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study start1 Jul 2011
- Primary completion1 Nov 2014
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Espen Walderhaug, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891045
- Sponsor's protocol ID
- OQ45-11-1
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2012
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amble I, Gude T, Stubdal S, Oktedalen T, Skjorten AM, Andersen BJ, Solbakken OA, Brorson HH, Arnevik E, Lambert MJ, Wampold BE. Psychometric properties of the outcome questionnaire-45.2: the Norwegian version in an international context. Psychother Res. 2014;24(4):504-13. doi: 10.1080/10503307.2013.849016. Epub 2013 Nov 5.
PubMed 24188797Brorson HH, Arnevik EA, Rand K. Predicting Dropout from Inpatient Substance Use Disorder Treatment: A Prospective Validation Study of the OQ-Analyst. Subst Abuse. 2019 Aug 15;13:1178221819866181. doi: 10.1177/1178221819866181. eCollection 2019.
PubMed 31452601
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction Treatment Dropout Prevention - Impact of Online Patient Feedback (OQ-45.2) to Therapist
- ClinicalTrials.gov ID
- NCT01891045
- Acronym / sponsor ID
- OQ45-11-1
- Conditions
- Drug Addiction, Drug Abuse
- Keywords
- Psychotherapy, Drug addiction, Drop-out, OQ-45.2, Clinical trial, Randomized Controlled Trail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 Jul 2011
- Primary completion
- 1 Nov 2014 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 2 Jul 2013 (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.
Dropout represents one of the largest problems in substance abuse treatment. International and Nordic research show that only 20 - 40 % of substance abusers complete treatment as intended. At the same time, one of the most consistent factors of favourable post-treatment outcome is treatment completion. In spite of the serious and continuous challenge dropout represents the phenomena is not well understood and there is a need to explore more of the factors that influence dropout and how it can be counteracted. As also stated: "…effective methods for reducing the problem of dropouts from treatment is one more area in need of further research" (NOU 2003:4, s 77).
For the general field of mental health one of the most important innovations involves providing therapists with patient feedback about their progress. The most well-established and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has been shown to improve treatment outcomes, including reduced treatment dropout and length of treatment, but the system is yet to be utilized with a substance abusing patient group. The aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing patients.
Detailed description
Hypotheses and research questions
- The OQ-45.2 feedback will be effective in identifying patients at risk of dropout of substance abuse treatment.
1a. The condition were feedback is withheld from the therapist, will correctly identify patients who will dropout.
Research Question: Is there variation in the accuracy of dropout prediction as a function of age, gender differences or type of substance abuse?
- The OQ-45.2 feedback will be effective in reducing dropout in outpatient substance abuse treatment.
2a. The feedback condition will result in less dropout than the no-feedback condition.
Research Question: Is there a variation in the OQ-45.2 preventive dropout effect due to age, gender or type of substance abuse?
- The OQ-45.2 feedback will shorten length of inpatient substance abuse treatment.
3a. The feedback condition will identify patients who are ready to terminate therapy.
Research Question: Is there variation in identification of patients ready to terminate as a function of age, gender differences or type of substance abuse?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients merely monitored on background variables to function as a baseline of comparison |
| Prediction | Active comparator | Behavioral: OQ-45.2 no feedbackPatients randomized to this condition completes the OQ-45.2 weekly, but the reports are withheld from therapists and patients. |
| Intervention | Experimental | Behavioral: OQ-45.2Patients and therapists uses the feedback-system as intended, with real-time feedback to the therapist and full use of the suggested interventions |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary diagnosis of addiction, F10-19, using the International Classification of Diseases, admitted in 2011-2014 for treatment at the department of addiction treatment - youth, Oslo University Hospital
Key exclusion criteria (1 listed)
- Ongoing psychoses, severe language difficulties
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 |
|---|---|---|
| OQ-45.2 no feedbackCompletion of the OQ-45.2 before each session, but no feedback to therapists or patients | Behavioural | Prediction |
| OQ-45.2Completion of the OQ-45.2 with real-time feedback to the therapist and full use of the suggested interventions every week of the treatment program | Behavioural | Intervention |
Primary outcome
Drop-out from residential SUD treatment
Time frame: Four years
Exit reason from residential Substance Use Disorder treatment (Drop-out or completed as planned)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Results publication: PubMed 24188797Amble I, Gude T, Stubdal S, Oktedalen T, Skjorten AM, Andersen BJ, Solbakken OA, Brorson HH, Arnevik E, Lambert MJ, Wampold BE. Psychometric properties of the outcome questionnaire-45.2: the Norwegian version in an international context. Psychother Res. 2014;24(4):504-13. doi: 10.1080/10503307.2013.849016. Epub 2013 Nov 5.
- Results publication: PubMed 31452601Brorson HH, Arnevik EA, Rand K. Predicting Dropout from Inpatient Substance Use Disorder Treatment: A Prospective Validation Study of the OQ-Analyst. Subst Abuse. 2019 Aug 15;13:1178221819866181. doi: 10.1177/1178221819866181. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OQ-45.2 no feedback and OQ-45.2 in people with Drug Addiction and Drug Abuse, run by Oslo University Hospital at 2 sites in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Drop-out from residential SUD treatment (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891045, which also lists 2 linked publications.
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 24 Jan 2024.