The impact of a decision aid on depressed patients' involvement in shared decision-making

ISRCTN	ISRCTN17611852
DOI	https://doi.org/10.1186/ISRCTN17611852
Protocol serial number	AMC2013-10
Sponsor	Al Amal hospital ‎
Funder	Al Amal hospital ‎(South Arabia)

Submission date: 30/10/2014
Registration date: 25/11/2014
Last edited: 25/11/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Khalaf Aljumah
Scientific

PO Box 33626
Riyadh
11458
Saudi Arabia

Study information

Primary study design	Interventional
Study design	Pilot randomized controlled double blind study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The impact of a decision aid on depressed patients' involvement in shared decision-making: a pilot randomized controlled double blind study
Study acronym	Shared decision-making (SDM)
Study objectives	Decision aids can improve patient's participation in SDM more than standard counseling.
Ethics approval(s)	Al Amal Complex for Mental Health in Riyadh, Saudi Arabia, October 2013, ref: AMC2013-10 ‎
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	N/A
Completion date	01/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	44
Key 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
Key exclusion criteria	1. Patients having a psychosis history 2. Drug dependency history
Date of first enrolment	01/03/2014
Date of final enrolment	01/05/2014

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Al Amal Hospital

SHOBAH
PO box ‎‏87904‏
Riyadh
11652‎
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes