Plain English Summary
Background and study aims
Patient involvement in decisions regarding their medical treatment has increased in recent years. Shared decision making (SDM) is a process whereby patents and healthcare professionals discuss healthcare options together and come up with a treatment plan. Patient decision aids (DAs) are resources that help people make decisions about their healthcare and encourage them to participate in SDM. Here, we want to develop and test a DA that supports depressed patients in making decisions regarding their treatment and improve the quality of these decisions by getting them more involved in the SDM process.
Who can participate?
Patients aged 18-60, diagnosed with depression and currently taking at least one antidepressant medication.
What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 (intervention group) use the test DA before participating in a SDM session. Those in group 2 (control arm) are not given access to the test DA before participating in a SDM session.
What are the possible benefits and risks of participating?
The study was designed to minimize any risks. All patients are given information regarding the security of data collected. They also have the right to withdraw from the study at any time with no effect on the relationship between the patients and health care team.
Where is the study run from?
The outpatients department in Al Amal Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
March 2014 to May 2014
Who is funding the study?
Al Amal Hospital (Saudi Arabia)
Who is the main contact
Khalaf Aljumah
khalafaljumaah@yahoo.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AMC2013-10
Study information
Scientific title
The impact of a decision aid on depressed patients' involvement in shared decision-making: a pilot randomized controlled double blind study
Acronym
Shared decision-making (SDM)
Study hypothesis
Decision aids can improve patient's participation in SDM more than standard counseling.
Ethics approval
Al Amal Complex for Mental Health in Riyadh, Saudi Arabia, October 2013, ref: AMC2013-10
Study design
Pilot randomized controlled double blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
An information participation sheet was distributed to all patients during recruitment phase.
Condition
Major Depressive Disorder
Intervention
Arm one : intervention group. Depressed patients used the DA before attending SDM session.
Arm two: control group. Depressed patients attended SDM session without using DA.
The same treatment, drug, doses, frequency and duration of treatment will be used in both groups and the local and international guidelines regarding the doses and duration of treatment followed.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Change in observing patient involvement in the decision making scale.
This was collected once during the an interview involving the patient with researcher when attending a routine outpatient clinic appointment. A data collection sheet and OPTION scale was used.
Secondary outcome measures
N/A
Overall trial start date
01/03/2014
Overall trial end date
01/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV)
2. Aged between 18-60
3. Using at least one antidepressant medication
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
44
Participant exclusion criteria
1. Patients having a psychosis history
2. Drug dependency history
Recruitment start date
01/03/2014
Recruitment end date
01/05/2014
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Al Amal Hospital
SHOBAH
PO box 87904
Riyadh
11652
Saudi Arabia
Sponsor information
Organisation
Al Amal hospital
Sponsor details
SHOBAH
PO box 87904
Riyadh
11652
Saudi Arabia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Al Amal hospital (South Arabia)
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
Basic results (scientific)
Publication list