1. Mapping relationship and determination of more prominent symptoms in GAD and Bipolar disorder network
2. Finding appropriate psychological treatment
Design
Replicated single-case experimental design with convenience sampling
Settings and conduct
Using data from the American Comorbidity Survey, the polychoric correlation matrix of the symptoms was extracted and their relationship map was plotted based on four indices: closeness, betweenness, strength, and expected effect. After identifying the most important symptoms, treatment protocol will be designed with a cognitive-behavioral approach and third-wave treatments. In the intervention phase, after the selection of patients with bipolar disorder (n=6) and baseline evaluation in 3 sessions, psychotherapy interventions will be conducted in the psychiatric ward of Hafez Hospital according to designed protocol. This study is a replicated single-case experimental design in which each patient acts as their control group. Patients will be evaluated for depression, anxiety and mania variables and the results are compared with pre-treatment conditions. To investigate the reliability of therapeutic effects, patients will be re-evaluated for aforementioned variables 1 month after the end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion:
1) Bipolar disorder
2) Stable condition and adequate pharmacological treatment in previous 3 months
3) Ages 15-54 years
4) No psychological treatment at the time or before entering the study
5) Signing a written consent
Exclusion:
1) Acute phase of bipolar disorder
2) Active drug abusers
3) Borderline personality disorder
4) Severe physical disabilities
5) Mental retardation
Intervention groups
ِDesigned protocol using a cognitive behavioral and third-wave therapies to target more important symptoms
Main outcome variables
Assessment of Depression; Assessment of Anxiety; Assessment of Mania
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141221020378N3
Registration date:2020-03-18, 1398/12/28
Registration timing:registered_while_recruiting
Last update:2020-03-18, 1398/12/28
Update count:0
Registration date
2020-03-18, 1398/12/28
Registrant information
Name
seyed ali dastgheib
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
adastgheib@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Diagnosis and Treatment of Bipolar Disorder Based on Symptoms Network Data Analysis
Public title
Determination of the most important symptoms of bipolar disorder and treatment of the disease based on them
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Bipolar disorder
Stable condition and adequate pharmacological treatment in the previous 3 months
Ages 15-54 years
No psychological treatment at the time or before entering the study
Signing a written consent
Exclusion criteria:
Individuals in the acute phase of bipolar disorder
Active drug abusers
Borderline personality disorder
Severe physical disabilities
Mental retardation
Age
From 15 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Hafez Hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71946-34786
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.SUMS.REC.1398.1188
Health conditions studied
1
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Assessment of Depression
Timepoint
Immediately after each session of treatment and 1 months after end of treatment
Method of measurement
Beck Depression Inventory; Hamilton Rating Scale for Depression
2
Description
Assessment of Anxiety
Timepoint
Immediately after each session of treatment and 1 months after end of treatment
Method of measurement
Beck Anxiety Inventory
3
Description
Assessment of Mania
Timepoint
Immediately after each session of treatment and 1 months after end of treatment
Method of measurement
Young Mania Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the new network theory of mental disorders, the causal relationship between symptoms and the importance of more central symptoms in treatment has been emphasized. Using data of the American Comorbidity Survey, the polychoric correlation matrix of the symptoms was extracted with the help of the psych software and the correlation map of the symptoms was plotted based on four indices: closeness, betweenness, strength, and expected effect. Using the unit scale, the algebraic sum of the indices was calculated and the most important indicators were identified. Then, the protocol was designed using a cognitive behavioral therapy and third-wave therapies to target more important symptoms. In the intervention phase, six patients with bipolar disorder were selected by convenience sampling method. The statistical method of this study will be replicated single-case experimental design that ethical in psychotherapy interventions in which each patient acts as their control group. The study will be conducted in the psychiatry ward of Hafez Hospital. After selecting patients and evaluating baseline in 3 sessions, psychotherapy interventions will be conducted in accordance with designed protocol in 12 sessions. Following psychotherapy interventions, patients will be evaluated for depression, anxiety and mania variables and the results are compared with pre-treatment conditions. To investigate the reliability of therapeutic effects, patients will be re-evaluated for aforementioned variables 1 month after the end of treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric centers affiliated to Shiraz University of Medical Sciences