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Effectiveness of Cognitive – Behavior Therapy – Recovery Oriented in Patients with Insomnia Comorbid with Anxiety and (or) Depressive Disorder

Protocol summary

Study aim
Main Objective: To determine the effectiveness of cognitive-behavioral therapy with a recovery-oriented approach in patients with insomnia co-morbid with anxiety disorders or depression.
Design
This research is a single-case experimental design consisting of a multiple baseline design among several subjects. Due to the single-subject design, the number of samples will be 8 people.
Settings and conduct
The statistical population of this study is patients with chronic insomnia comorbid with anxiety or depression disorders. After referral from the centers, the patients are screened based on the entry and exit criteria by interviewing the principal investigator. Then, a structured clinical interview is conducted and they are examined for the presence of sleep disorders. Patients who meet the criteria are entered into the study and answer the questionnaires. Then, the participants receive cognitive therapy with a recovery-oriented approach in 10 sessions according to the designed protocol and for 50 to 60 minutes. All subjects answer the questionnaires again during the treatment process, before the start of treatment, at the 5th and 10th sessions, and 2 months after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - At least 18 years of age, - Fluency in Persian, - Minimum education of a high school diploma, - Chronic insomnia with anxiety or depression disorders or both - Drug dose should be stable for six months before starting treatment and no increase in drug dose or start of new drug during treatment Exclusion criteria: - Psychosis, bipolar disorder, substance dependence or substance abuse, - Having obvious suicidal thoughts,
Intervention groups
Cognitive-behavioral therapy with a recovery-oriented approach
Main outcome variables
Cognitive therapy with a recovery-oriented approach; Insomnia symptoms; Anxiety severity; Depression severity; Quality of life;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250531066001N1
Registration date: 2026-01-02, 1404/10/12
Registration timing: retrospective

Last update: 2026-01-02, 1404/10/12
Update count: 0
Registration date
2026-01-02, 1404/10/12
Registrant information
Name
Abbas DanandehpourKhameneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 4159
Email address
danandehpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-10-07, 1404/07/15
Actual recruitment start date
2025-05-05, 1404/02/15
Actual recruitment end date
2025-10-07, 1404/07/15
Trial completion date
2025-10-07, 1404/07/15
Scientific title
Effectiveness of Cognitive – Behavior Therapy – Recovery Oriented in Patients with Insomnia Comorbid with Anxiety and (or) Depressive Disorder
Public title
Effectiveness of Cognitive – Behavior Therapy – Recovery Oriented in Patients with Insomnia Comorbid with Anxiety and (or) Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Must be at least 18 years of age, - Fluent in Persian, - Minimum education: Diploma, - Having chronic insomnia disorder according to DSM5 diagnostic criteria, - Having anxiety or depression disorders or both according to SCID-I, - Having a stable drug dose for six months before starting treatment and not increasing the drug dose or starting a new drug during treatment
Exclusion criteria:
- Having psychosis, bipolar disorder, substance dependence or abuse, - Being involved in other concurrent psychological treatments, ,- Having overt suicidal thoughts, - Having a debilitating physical illness or serious medical condition
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 8
Actual sample size reached: 8
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 University of Social Welfare and Rehabilitation Sciences
Street address
No. 15, Zomorodkar Alley, Shavari Alley, Shariati Street, Qolhak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1948743161
Approval date
2025-04-30, 1404/02/10
Ethics committee reference number
IR.USWR.REC.1404.022

Health conditions studied

1

Description of health condition studied
Insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia

Primary outcomes

1

Description
Insomnia
Timepoint
Before starting cognitive therapy with a recovery-oriented approach, during sessions 5 and 10 of treatment, and then 2 months after treatment
Method of measurement
Response to the Insomnia Severity Index (ISI) questionnaire

2

Description
Anxiety
Timepoint
Before starting cognitive therapy with a recovery-oriented approach, during sessions 5 and 10 of treatment, and then 2 months after treatment
Method of measurement
Answers to the Beck Anxiety Inventory BAI Anxiety Severity Index

3

Description
Depression
Timepoint
Before starting cognitive therapy with a recovery-oriented approach, during sessions 5 and 10 of treatment, and then 2 months after treatment
Method of measurement
Response to the Beck Depression Inventory - Second Edition (BDI-II) Depression Severity Index

4

Description
Quality of life
Timepoint
Before starting cognitive therapy with a recovery-oriented approach, during sessions 5 and 10 of treatment, and then 2 months after treatment
Method of measurement
Response to the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) Quality of Life Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After referral from the centers, the patients are screened based on the entry and exit criteria by interviewing the principal investigator. Then, a structured clinical interview is conducted by the researcher, who is a fourth-year resident assistant, and they are examined for the presence of sleep disorders. Patients who meet the criteria are included in the study and answer the questionnaires. Then, the participants receive cognitive therapy with a recovery-oriented approach in 10 sessions according to the designed protocol and for 50 to 60 minutes. All subjects answer the questionnaires again during the treatment process, before the start of treatment, at sessions 5 and 10, and 2 months after treatment.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatric Educational and Treatment Center (Aminabad)
Full name of responsible person
Abbas Danandehpour Khameneh
Street address
Tehran, Shahr-e Ray - Taghi Abad intersection - Shahid Rastegar Boulevard - Razi Psychiatric Educational and Treatment Center
City
Tehran
Province
Tehran
Postal code
1867612016
Phone
+98 21 3340 1220
Fax
+98 21 3340 1600
Email
razi@uswr.ac.ir
Web page address
https://razi.uswr.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Saeed Khanjani
Street address
Tehran, Velenjak, Daneshjoo Blvd., Kadayar Dead End, University of Rehabilitation and Social Health Sciences
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
pr@uswr.ac.ir
Web page address
https://researchdeputy.uswr.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Abbas DanandehPour khameneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shariati Street, above Mirdamad, Shavari Street, No. 15, Zomordkar Street
City
Tehran
Province
Tehran
Postal code
1948743161
Phone
+98 21 2285 4159
Email
danandehpour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Abbas Danandehpour Khameneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shariati Street, above Mirdamad, Shvari Street, No. 15, Zomordkar Street
City
Tehran
Province
Tehran
Postal code
1948743161
Phone
+98 21 2285 4159
Email
danandehpour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Abbas Danandehpour Khameneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shariati Street, above Mirdamad, Shvari Street, No. 15, Zomordkar Street
City
Tehran
Province
Tehran
Postal code
1948743161
Phone
+98 21 2285 4159
Email
danandehpour@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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