Bipolar disorder is one of ten most debilitating diseases in the world. In addition to posing a burden on the healthcare system leads to a lessened quality of life and increased occupational accidents amongst its sufferers. This study demonstrates the effectiveness of psychoeducation intervention along with a patient support system in management of this disorderThis study was done on Bipolar patients. Inclusion criteria were being in spectrum of 18-60 year old; past history of 2 episodes during 2 years or 3 episodes during 5 years and being in euthymic phase. Exclusion criteria included age >60 years or <18 years old; less than 2episodes during 2 years or less 3 episodes during 5 years; and being in acute phase or with sever residual symptoms . In this trial, a total of 108 patients, divided equally into two groups, were randomly assigned to receive pharmacotherapy alone treatment (control group) and psychoeducation along with pharmacotherapy (intervention group) for a two year period.
“control” group, throughout the research period, only received pharmacological therapy by referring to the health carer of their choosing. Each group was evaluated, once every 6 months for a period of 18 months, in the areas of “quality of life”, “symptoms of relapse”, “pharmacotherapy compliance” and “number of hospital admission for recurrence of bipolar disorder ”.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202159028N1
Registration date:2012-08-27, 1391/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-27, 1391/06/06
Registrant information
Name
Arvin Hedayati
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1620 6747
Email address
hedayatia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Psychiatric Research Center of Shiraz University Of Medical Science
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-07-21, 1389/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of a systematic intervention program on quality of life, relapse prevention and medication compliance in patients with bipolar disorder
Public title
Impact of a psycho-education on patients with bipolar disorder
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria : 18-60 year old; past history of 2 episodes during 2 years or 3 episodes during 5 years; in euthymic phase.
exclusion criteria: >60 years or <18 years old;less than 2episodes during 2 years or less 3 episodes during 5 years; in acute phase or with sever residual symptoms
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commite of Shiraz medical university
Street address
Shiraz medical university
City
shiraz
Postal code
Approval date
2010-12-26, 1389/10/05
Ethics committee reference number
2871
Health conditions studied
1
Description of health condition studied
bipolar mood disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
quality of life. medication adherence. recurrence.admision
Timepoint
6 ,12 and 18 months after begining of study
Method of measurement
WHO QOL BREF. hamilton depression scale. Bech Rafaelsen mania scale. Medication adherence Rating scale
Patients in intervention group, received standard pharmacotherapy for BpD and also enrolled for simple individual psychoeducation.
Program consisted of 8 sessions each consisting of a 50 minute session per week of a short form of psychoeducation course, derived from studies of Colom, F. and Vieta,E. (19).
Sessions of psychoeducation were performed by a psychiatry resident who was blinded to treatment. All psychoeducation treatment sessions for all patients were performed by the same resident who conducted a one-on-one session with each individual patient.
Psychoeducation programs and discussions were presented to the patients in the following format:
Session 1: Understanding BpD. and its aetiology.
Session 2: Familiarisation with symptoms of mania and hypomania.
Session 3: Understanding signs of depression and other psychological episodes.
Session 4: Awareness of causes and prognosis.
Session 5: Education about the function, types and adverse side effect of mood stabiliser medication.
Session 6: Functions, types and adverse effects of antimanic and antidepressant medications. Patients also receive information about the risk of discontinuation of these medications.
Session 7: Learning how to detect any future episodes of relapse.
Session 8: Strategies and plans ought to be taken upon early detection of symptoms and self directed to new situations.
These 8 weekly scheduled sessions were conducted face to face in the clinic of psychology at Hafez Hospital.
The first 10 minutes of each sitting was allocated to establishing rapport with the patient, and a short question and answer session. During this period, the patients were asked to explain, in their own words, their understanding of all presented material. Any misconstrued discussed and explained in detail.
After first 10 minutes the researcher gave all relevant information in layman language about the particular topics for 40 minutes. The strategies and plans for early detections of symptoms discussed.
After 8 sessions of face to face simple individual education, intervention continued by way of scheduled monthly telephone contact to remind patients of their next appointment. Each telephone contact consisted of a 10-minute question and answer session where the patient’s queries were thoroughly responded to.
Follow-up telephone contact for each patient was then scheduled for the subsequent 18 months.
Category
Lifestyle
2
Description
Patients who were randomised in the control group were continuing standard pharmacotherapy by their psychiatrists of choice