Protocol summary

Study aim
The purpose of this study is to compare the effectiveness of positive psychotherapy and treatment based on acceptance and commitment on experiential avoidance, self-compassion, emotion regulation and body image of women with body dysmorphic
Design
A controlled, parallel-group, unblinded, randomized clinical trial on 60 patients
Settings and conduct
After initial assessment, receiving informed consent and completing pre-test, 60 women with body dysmorphic disorder will be allocated to interventions and control groups. Then, the interventions will be implemented on intervention group in Iran Psychiatric Hospital. At the end of intervention and after 3 month, intervention groups and control group complete post-test and follow-up questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being diagnosed with body dysmorphic; Ability to read and write; Being a women; Age between 18 to 45 years old. Exclusion criteria: Substance abuse; Receiving simultaneous psychological treatments
Intervention groups
First intervention group: 8 sessions of positive group psychotherapy will be provided . The interval between sessions is one week. The intervention period lasts two months. The content of this therapy includes strengthening positive thoughts, emotions, and behaviors. Second intervention group: 8 acceptance and commitment group intervention sessions will be provided. The interval between sessions is one week. The intervention period lasts two months. The content of this therapy includes encouraging the patient to accept the situations, circumstances, and failures that have occurred in their life. Control group: This group will not receive the treatment.
Main outcome variables
Body image; difficulty in emotion regulation; acceptance and commitment; experiential avoidance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250315065087N1
Registration date: 2025-04-23, 1404/02/03
Registration timing: registered_while_recruiting

Last update: 2025-04-23, 1404/02/03
Update count: 0
Registration date
2025-04-23, 1404/02/03
Registrant information
Name
Samira Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 9108 9408
Email address
samira66ahmadi22@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-19, 1404/01/30
Expected recruitment end date
2025-05-20, 1404/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Positive Psychotherapy with Acceptance and Commitment Therapy on Experiential Avoidance, Self-Compassion, Emotion Regulation and Body Image of Women with Body Dysmorphia
Public title
Comparison of the Effectiveness of Positive Psychotherapy with Acceptance and Commitment Therapy in Women with Body Dysmorphia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being diagnosed with body dysmorphic disorder which will be assessed using 5th version of the structured clinical interview for diagnostic and statistical manual of mental disorders (SCID-5) Being a woman Ability to read and write Age between 18 and 45 years old
Exclusion criteria:
Receiving simultaneous psychotherapy Substance abuse
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The process of random allocation of participants to three groups of interventions and control includes both creating a random sequence and concealing the random allocation. Firstly, using the random sequence rule, 60 papers for participants of the interventions and control groups (which will be marked with A, B, and C and will not be defined to avoid bias) will be thrown into a lottery container and then the papers will be removed from the lottery container - without replacement - and the created sequence will be recorded. Then, using the snooze method, 60 envelopes will be prepared and each of the random sequences created will be recorded on a card and will be placed in the envelopes in order, and the envelopes will be also numbered. Then, the envelopes will be given to the participants based on the order of entering the study, so the grouping of each will be determined.
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 Islamic Azad University-Tonekabon Branch
Street address
Vali Abad Ave, Khalij Fars Blv, Tonekabon
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Approval date
2024-12-18, 1403/09/28
Ethics committee reference number
IR.IAU.TON.REC.1403.168

Health conditions studied

1

Description of health condition studied
Body Dysmorphic Disorder
ICD-10 code
F45.22
ICD-10 code description
Body dysmorphic disorder

Primary outcomes

1

Description
Body image score in Body Image Scale
Timepoint
Before intervention (pre-test), after intervention (post-test), 3 months after intervention (follow-up)
Method of measurement
Body Image Scale

Secondary outcomes

1

Description
Self-Compassion score in Self-Compassion Scale
Timepoint
Before intervention (pre-test), after intervention (post-test), 3 month after intervention (follow-up)
Method of measurement
Self-Compassion Scale

2

Description
Difficulty in emotion regulation score in Difficulty in Emotion Regulation Scale
Timepoint
Before intervention (pre-test), after intervention (post-test), 3 month after intervention (follow-up)
Method of measurement
Difficulty in Emotion Regulation Scale

3

Description
Acceptance and action score in Acceptance and Action Scale
Timepoint
Before intervention (pre-test), after intervention (post-test), 3 month after intervention (follow-up)
Method of measurement
Acceptance and Action Scale

4

Description
Experiential avoidance score in Experiential Avoidance Scale
Timepoint
Before intervention (pre-test), after intervention (post-test), 3 month after intervention (follow-up)
Method of measurement
Experiential Avoidance Scale

Intervention groups

1

Description
"Intervention group 1": 20 women with body dysmorphic disorder will participate in this group. This group will receive the acceptance and commitment intervention in 8 sessions, each lasting 90 minutes. inrevention is carried out in group setting. This intervention is based on the Eifert and Forsythe protocol. The interval between sessions is one week. The intervention period lasts two months. The content of this approach is as follows. First session: Establishing a therapeutic relationship, introducing individuals to the research topic; Second session: Discussion about experiences and their evaluation, efficiency as a measurement criterion, creating creative frustration; Third session: Expressing control as a problem, introducing desire as another response, engaging in purposeful actions; Fourth session: Using the technique of cognitive distancing, interfering with the functioning of problematic language chains, weakening one's alliance with thoughts and emotions; Fifth session: Observing the Self as Context, Undermining the Self as Self-Concept, and Expressing the Self as Observer; Sixth session: Application of mindfulness techniques, modeling of going out of mind, learning to see experiences as a process; Seventh session: Accepting yourself as an observer, accepting emotions instead of avoiding them; Eighth session 8: Discussion and review of previous sessions
Category
Treatment - Other

2

Description
"Intervention group 2": 20 women with body dysmorphic disorder will participate in this group. This group will receive positive psychology intervention. The intervention consists of 8 sessions and every session lasts 90 minutes. inrevention is carried out in group setting. The interval between sessions is one week. The intervention period lasts two months. The content of this approach is as follows. First session: Getting to know each other and building rapport, not blaming or judging, clarifying the assumptions and roles of positive psychotherapy, presenting the assignment; Second session: Reviewing the previous session's practice, expressing and introducing yourself positively; Third session: Review of the previous session, planning and implementing the client's capabilities, sense of commitment, relationship between capabilities used and emotions experienced, providing taste techniques to improve positive emotions and experience a sense of hope, optimism, and focus; Fourth session: Presenting the assignment from the previous session, implementing help the client understand the role of past memories (good or bad), the role and focus on these memories as they lead to symptoms of the disorder, presenting the assignment; Fifth session: Reviewing the previous session's exercise, implementing and designing the forgiveness structure as a tool to eliminate anger and bitterness of negative emotions, the forgiveness technique for writing letters as a tool to eliminate errors, implementing the sugar-making technique to increase the level of happiness in oneself; Sixth session: Reviewing the assignments from the previous session, paying attention to good or bad memories, and exploring strategies to reduce signs of physical deformity, paying attention to signs of gratitude to increase the individual's self-esteem and self-confidence; Seventh session: Review of the previous session's assignment, client's feedback on the positive energy process; Eighth session: Review of the previous session's exercise, discussion of the whole life approach, offering suggestions for new ideas for climbing and working, and providing exercises and activities, reviewing unreviewed techniques and achievements of the treatment process.
Category
Treatment - Other

3

Description
"Control group": 20 women with body dysmorphic disorder who will not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran psychiatry hospital
Full name of responsible person
Ameneh Khalatbari
Street address
Mahdavi Kani Ave, Sarda Hejazi Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1315113989
Phone
+98 21 4450 3395
Email
amenehkhalatbari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Ghane
Street address
Vali Abad Ave, Khalij Fars Blv, Tonekabon
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 3475
Email
masoodghane@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Samira Ahmadi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vali Abad Ave., Khalij Fars Blv., Tonekabon
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1105
Email
Samira66ahmadi22@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samira Ahmadi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vali Abad Ave, Khalij Fars Blv, Tonekabon
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1105
Email
Samira66ahmadi22@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samira Ahmadi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vali Abad Ave., Khalij Fars Blv., Tonekabon
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1105
Email
Samira66ahmadi22@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not allowed by the university.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
SPSS file of participants data, treatment protocol of study, and informed consent form will be available if necessary.
When the data will become available and for how long
After the execution of study
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
People who conduct research on patients with body dysmorphic disorder
From where data/document is obtainable
By email: Samira66ahmadi22@gmail.com
What processes are involved for a request to access data/document
Data will be sent by email after request.
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