Condition category
Mental and Behavioural Disorders
Date applied
30/10/2014
Date assigned
25/11/2014
Last edited
25/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Khalaf Aljumah

ORCID ID

Contact details

PO Box 33626
Riyadh
11458
Saudi Arabia

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 measures

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

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

http://www.alamal.med.sa ‎

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes