Condition category
Infections and Infestations
Date applied
16/03/2012
Date assigned
28/03/2012
Last edited
18/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Until recent years, HIV illness was characterized by a predominately downward trajectory that ended with death after months of debilitating AIDS-defining diseases. The advent in 1996 of the new highly active antiretroviral therapies (HAART) extended survival and reduced the prevalence of AIDS opportunistic infections in many HIV-infected individuals. However, HAART has also created new challenges with important implications for mental health interventions. Threats regarding physical survival have to a large extent been replaced by the distress associated with chronic illness. Hence, as HIV-infected individuals live longer, it is increasingly important for clinicians and researchers to better understand and improve well-being and quality of life. Consequently, this study aims at testing a web-based intervention that was developed to address mental health issues among HIV-infected individuals.

Who can participate?
The study recruited a group of HIV-infected patients, aged 18 or older, on antiretroviral therapy at an outpatient clinic at Oslo University Hospital (Norway).

What does the study involve?
All participants that accepted the study invitation were randomly allocated into two groups (experiment or control group). Those participants that were assigned to the experiment group were given access to the intervention, called Avanti. Avanti is a web-based self-help program that is designed to improve and manage HIV patients' symptoms of depression and well-being. Avanti consists of 13 sessions and lasts for 4 weeks. The control group did not receive any intervention other than medical treatment as usual. Control participants were, however, given access to Avanti when the final survey data were collected. All participants were surveyed at the start of the study and 1 and 3 months later.

What are the possible benefits and risks of participating?
Participants that receive the web-based intervention can potentially experience decreases in depressive symptoms and increases in well-being. There are no expected negative side effects from treatment.

Where is the study run from?
The study is conducted at the outpatient clinic at the Department of Infectious Diseases, Ullevål, Oslo University Hospital (OUH).

When is the study starting and how long is it expected to run for?
The study started in February 2011 and the final data collection ended in October 2011.

Who is funding the study?
The study was funded by Abbott Laboratories (Norway) and the intervention was funded by Medicus Plesner (Norway).

Who is the main contact?
Filip Drozd
fd@changetech.no

Trial website

Contact information

Type

Scientific

Primary contact

Mr Filip Drozd

ORCID ID

Contact details

Changetech AS
Gaustadalleen 21
Oslo
0349
Norway
+47 97 516 188
fd@changetech.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A digital psychological intervention for HIV patients in adjunct to medical treatment – a randomized clinical trial

Acronym

Study hypothesis

1. The web-based intervention decreases symptoms of depression at 3 months as compared to the treatment-as-usual group
2. The web-based intervention increases satisfaction with life at 3 months as compared to the treatment-as-usual group
3.1. The web-based intervention increases positive affect at 3 months as compared to the treatment-as-usual group
3.2. The web-based intervention decreases negative affect at 3 months as compared to the treatment-as-usual grou
3.3. The web-based intervention increases overall mood at 3 months as compared to the treatment-as-usual group
4. Are there any moderators (e.g., age, time since first HIV seropositive test, time since start of antiretroviral therapy) of treatment effect on depressive symptoms, life satisfaction, and positive and negative affect?

Ethics approval

1. Oslo University Hospital Ethics Committee, 27/09/2010, ref: 1557
2. Regional Ethics Commitee (http://helseforskning.etikkom.no), 15/02/2011, ref: 2010/2948-1

Study design

Two-armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Patients infected with HIV for more than 12 months.

Intervention

The intervention is called Avanti.

Avanti is a web-based self-help program that is designed to improve and manage HIV patients' symptoms of depression and well-being. Avanti consists of 13 sessions and lasts for 4 weeks. Once a user is registered he or she will receive an email every Monday, Wednesday, and Friday with a unique link to each new session. Every session consists of unique content. The intervention contains psychoeducative information and applies techniques, and exercises from positive psychology and metacognitive therapy. These techniques and exercises are designed to improve well-being and manage negative emotions and thoughts. However, Avanti is not intended as a replacement but rather a supplement to existing treatments.

The control group did not receive any intervention other than medical treatment as usual. Control participants were, however, given access to Avanti when the final survey data were collected.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977)
2. Satisfaction with Life Scale (Diener et al., 1985)
3. Positive & Negative Affect Schedule (PANAS; Watson, Clarke & Tellegen, 1988)

All participants were measures on primary outcomes on baseline, 1, and 3 months post-intervention enrollment.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/02/2011

Overall trial end date

15/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients registered at the outpatient clinic at Department of Infectious Diseases, Ullevål, Oslo University Hospital
2. 18 years or older
3. Norwegian - speaking
4. White - caucasian
5. HIV infected
6. Not infected by drug use
7. On antiretroviral therapy >12 months prior to inclusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 60 patients were needed across the two treatment arms

Participant exclusion criteria

Does meet inculsion criteria

Recruitment start date

15/02/2011

Recruitment end date

15/10/2011

Locations

Countries of recruitment

Norway

Trial participating centre

Changetech AS
Oslo
0349
Norway

Sponsor information

Organisation

Abbott Laboratories (Norway)

Sponsor details

Martin Linges vei 25
PO Box 1
N-1330 Fornebu
Oslo
1330
Norway

Sponsor type

Industry

Website

http://www.abbott.com/

Funders

Funder type

Industry

Funder name

Abbott Laboratories (Norway)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Medicus-Plesner (Norway)

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