Comparing the effectiveness of cognitive rehabilitation therapy and Progressive Muscle Relaxation on insomnia symptoms, cognitive symptoms and emotional symptoms in patients with insomnia disorder.
Design
This clinical trial study has two experimental groups and is randomized on 34 people. G POWER program is used to estimate the sample size and Random Generator software is used for randomization.
Settings and conduct
The sample will be selected from individuals who refer to psychiatric clinics of Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-age older than 18
2-Meeting DSM-5 criteria for insomnia disorder
3-No presence of suicidal ideation or plans
4-No presence of organic diseases or degenerative and unstable medical condition
• Exclusion criteria:
1-Not attending more than one session of rehabilitation or relaxation treatment
2-Presence of another untreated concurrent sleep disorder
3-Presence of severe psychiatric disorders (e.g; psychotic disorders, severe depression, bipolar disorder, substance dependence, or substance abuse)
4-Initiation of any psychological or medical treatment
5-taking drugs that activate the central nervous system
Intervention groups
The research sample includes 34 people who were randomly divided into two groups of 17 people. The first experimental group received cognitive rehabilitation therapy according to a protocol in the form of 12 sessions (3 days a week), each session lasting 60 minutes. The second experimental group received progressive muscle relaxation treatment according to a protocol in the form of 12 sessions (3 days a week) for 45 minutes each session.
Main outcome variables
Insomnia symptoms, cognitive symptoms and emotional symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220817055739N1
Registration date:2022-12-31, 1401/10/10
Registration timing:registered_while_recruiting
Last update:2022-12-31, 1401/10/10
Update count:0
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Mehdi Bazi Alahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3032 1111
Email address
mehdi.bazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Cognitive rehabilitation therapy (CRT) and Relaxation therapy (RT) on patients with insomnia
Public title
Comparison of the effectiveness of Cognitive rehabilitation therapy (CRT) and Relaxation therapy (RT) on patients with Insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age older than 18
Meeting DSM-5 criteria for insomnia disorder
No presence of suicidal ideation or plans
No presence of organic diseases or degenerative and unstable medical condition
Exclusion criteria:
Not attending more than one session of rehabilitation or relaxation treatment
Presence of another untreated concurrent sleep disorder
Presence of severe psychiatric disorders (e.g; psychotic disorders, severe depression, bipolar disorder, substance dependence, or substance abuse)
Initiation of any psychological or medical treatment
taking drugs that activate the central nervous system
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Iran - Tehran - Shahid Chamran Highway Yemen Street - Shahid Arabi Street - next to Ayatollah Taleghani Hospital - Shahid Beheshti School of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.SBMU.MSP.REC.1401.249
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia
Primary outcomes
1
Description
Symptoms of insomnia
Timepoint
Before the start of the interventions, during interventions, two months after the intervention
Method of measurement
1-Insomnia Severity Index (ISI), 2-Consensus Sleep Diary (CSD)
2
Description
Cognitive symptoms
Timepoint
Before the start of the interventions, during interventions, two months after the intervention
Method of measurement
1-Stroop Color and Word Test (SCWT), 2-Tower of London Test (TOL)
3
Description
Emotional symptoms
Timepoint
Before the start of the interventions, during interventions, two months after the intervention
Intervention group: The experimental group receives cognitive rehabilitation therapy according to a protocol in the form of 12 sessions (3 days a week), each session lasting 60 minutes.
Category
Rehabilitation
2
Description
Intervention group: The experimental group received Progressive Muscle Relaxation according to a protocol in the form of 12 sessions (3 days a week), each session lasting 45 minutes.