The impact of a decision aid on depressed patients' involvement in shared decision-making
| ISRCTN | ISRCTN17611852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17611852 |
| Secondary identifying numbers | AMC2013-10 |
- 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
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
Scientific
PO Box 33626
Riyadh
11458
Saudi Arabia
Study information
| Study design | Pilot randomized controlled double blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | An information participation sheet was distributed to all patients during recruitment phase. |
| 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 | 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 study start date | 01/03/2014 |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 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
PO box 87904
Riyadh
11652
Saudi Arabia
Sponsor information
Hospital/treatment centre
SHOBAH
PO box 87904
Riyadh
11652
Saudi Arabia
| Website | http://www.alamal.med.sa |
|---|---|
"ROR" |
https://ror.org/00zszzj16 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
