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
The impact of a decision aid on depressed patients' involvement in shared decision-making: a pilot randomized controlled double blind study
Shared decision-making (SDM)
Decision aids can improve patient's participation in SDM more than standard counseling.
Al Amal Complex for Mental Health in Riyadh, Saudi Arabia, October 2013, ref: AMC2013-10
Pilot randomized controlled double blind study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
An information participation sheet was distributed to all patients during recruitment phase.
Major Depressive Disorder
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.
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
Participant exclusion criteria
1. Patients having a psychosis history
2. Drug dependency history
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Al Amal Hospital
SHOBAH PO box 87904
Al Amal hospital
PO box 87904
Al Amal hospital (South Arabia)
Funding Body Type
Funding Body Subtype
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)