Protocol summary

Study aim
The purpose of the current study was to evaluate the efficacy of the integrated protocol of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy in patients with Relationship Obsessive-Compulsive Disorder (ROCD)
Design
Clinical trial in format of single case study with multiple baseline; three interventions of couple therapy of ACT, ACT for OCD and integrated treatment of ACT for OCD and couple therapy; random selection of two individuals with ROCD in each intervention; parallel interventions; one blind
Settings and conduct
In the current study, the studied sample were 6 couples with ROCD from universities of Tehran, Shahid Beheshti, Shahed, Tarbiat Modarres, Allameh Tabatabai, Kharazmi, Amir Kabir and Sharif and in each of the three mentioned treatments, 2 couples were selected randomly.Couples were unaware of the types of treatments in this study (a blind head).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being married (male or female); Diagnosis of OCD; Diagnosis of ROCD (score above one standard deviation of the ROCI and PROCSI); To lapse at least 6 months from marriage; consent to participate in the research and to sign a written consent. Exclusion criteria: Being treated for the past 6 months; History of substance abuse (due to interference with treatment sessions); Diagnosis of psychiatric disorders other than obsessive spectrum disorders, based on SCID-5-RV interview; Absence of the treatment in three consecutive sessions.
Intervention groups
Group 1- Integrated intervention of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy Group 2- Couple therapy of ACT Group 3- ACT for OCD
Main outcome variables
Obsession; Psychological flexibility; Marital satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131128015577N4
Registration date: 2019-10-19, 1398/07/27
Registration timing: retrospective

Last update: 2019-10-19, 1398/07/27
Update count: 0
Registration date
2019-10-19, 1398/07/27
Registrant information
Name
Soheila Ghomian
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 3627 0702
Email address
ghomian_s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-04-19, 1397/01/30
Actual recruitment end date
2019-05-05, 1398/02/15
Trial completion date
2019-09-03, 1398/06/12
Scientific title
Evaluation of the efficacy of the integrated protocol of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy in patients with Relationship Obsessive-Compulsive Disorder (ROCD)
Public title
Evaluation of the protocol of ACT in patients with obssesion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being married (male or female) Diagnosis of OCD Diagnosis of ROCD (score above one standard deviation of the ROCI and PROCSI) To lapse at least 6 months from marriage; consent to participate in the research and to sign a written consent
Exclusion criteria:
Being treated for the past 6 months History of substance abuse (due to interference with treatment sessions) Diagnosis of psychiatric disorders other than obsessive spectrum disorders based on SCID-5-RV interview Absence of the treatment in three consecutive sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 15
Actual sample size reached: 6
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method with the help of lottery
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were not aware of the types of interventions in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Design of integrated protocol of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
33191​18651
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.SHAHED.REC.1397.078

Health conditions studied

1

Description of health condition studied
Relationship Obsessive Compulsive Disorder
ICD-10 code
F42.2
ICD-10 code description
Compulsion mixed with obsessional thoughts

Primary outcomes

1

Description
Psychological Flexibility
Timepoint
Twice at baseline; three times during treatment; twice at follow-up (two weeks and four weeks after treatment)
Method of measurement
Acceptance and Action Questionnaire II (AAQ-II)

Secondary outcomes

1

Description
Relationship Obsessive and Compulsive Disorder
Timepoint
Twice at baseline; three times during treatment; twice at follow-up (two weeks and four weeks after treatment)
Method of measurement
Relationship Obsessive Compulsive Inventpry; Partner Related Obsessive Compulsive Symptom Inventory

2

Description
Marital Satisfaction
Timepoint
Twice at baseline; three times during treatment; twice at follow-up (two weeks and four weeks after treatment)
Method of measurement
Enrich Scale

Intervention groups

1

Description
Intervention group: Integrated intervention of the Acceptance and Commitment Therapy (ACT) for OCD and couple therapy: This intervention consists of 20 sessions that summarize the sessions of this intervention as follows: Sessions 1-4: Two sessions of OCD therapy (assessment of obssesion and introduction of treatment structure, creative frustration) and two sessions of couples therapy (assessment of couples and introduction of couple therapy orientation of ACT). Sessions 5 and 6: One OCD therapy (keep up the creative frustration) and one couple therapy (constructive frustration); Sessions 7-9: Two OCD therapy (realizing control and acceptance, mindfulness) and one couple therapy (acceptance and mindfulness training); Sessions 10-13: Two sessions of OCD therapy (introducing self as context and defusion) and two sessions of couple therapy (defusion and observation of thoughts); sessions 14-20: Three sessions of OCD therapy (focus on value and examine the barriers to value, committed action) and four sessions of couple therapy (focus on value and examine the barriers to value, committed action and self as context).
Category
Behavior

2

Description
Intervention group: Couple therapy of ACT:The number of sessions of this intervention is 10. Summary of Acceptance and Commitment Therapy (ACT) sessions are as follows: Session 1: Getting to know couples and presenting orientation of ACT; Session 2: Individual assessment; Session 3: Creative frustration, reviewing options and what issues are controllable and uncontrollable; Session 4: Mindfulness and Acceptance Training; Session 5: Cognitive defusion, Examining the barriers to paying thoughts, tagging thoughts and moving away from thoughts; Session 6: Observing thoughts; Session 7: Choosing valuable orientations; Session 8: Exploring the barriers to a worthy life; Session 9: Describing yourself as a texture in communication; Session 10: Committed action, end of treatment and prevention of recurrence.
Category
Behavior

3

Description
Intervention group: ACT for OCD: This intervention contains 10 sessions of Acceptance and Commitment Therapy (ACT) for OCD. At each meeting, the client's reactions to the previous meeting are first reviewed, a new issue raised, a new assignment determined, and a behavioral commitment agreed. At first, the type of therapeutic relationship is specified by metaphor of the "two mountains". Then, the treatment begins by gathering information about the obsessive thoughts and actions. The difference between obsessive thoughts and actions arises and shows how one happens without the other, but in the lives of their clients, they usually happen together. Then ask the clients what has been done so far to reduce obsessive thinking, what has been effective and what has not been effective. This shows that the only way to get rid of obsessive thinking is to do obsessive action, but it only works for a short period of time. The metaphor of "Obsessive Well" and "Monster Draw" was used to illustrate the ineffectiveness of one's attempts to control obsessive thinking. The function of these metaphors was to reduce the focus of the client on the decline of obsessive-compulsive thinking and to become aware of the difficulty of controlling it, which is called the Creative frustration in ACT. Sessions 3, 4, and 5 deal with how trying to control obsessive thinking rather than being the solution is the problem. The purpose of these sessions was to emphasize the limitations of control when internal events occure. Sessions 6, 7, and 8 focused on changing the psychological function of obsessive thinking from what is threatening to merely another verbal event. These sessions include training of defusion, communication with the present or mindfulness exercises and working on the self as a background. The last session (9 and 10) included discussions about the values of the client and increased behavioral commitments to pursue those values.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University
Full name of responsible person
Soheila Ghomian
Street address
Tehran university; Enghelab St; Enghelab Square; Tehran
City
Tehran
Province
Tehran
Postal code
1417414418
Phone
+98 21 5121 2421
Email
publicrel@ut.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Beheshti University
Full name of responsible person
Soheila Ghomian
Street address
Daneshjoo Boulevard; Shaheed Shahriari Square; Yemen St; Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1920
Email
pr.office@mail.sbu.ac.ir

3

Recruitment center
Name of recruitment center
Tarbiat Modarres University
Full name of responsible person
Soheila Ghomian
Street address
Tehran, Jalal Al Ahmad Highway, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 82880
Email
pres@modares.ac.ir

4

Recruitment center
Name of recruitment center
Allameh Tabataba'i University
Full name of responsible person
Soheila Ghomian
Street address
Tehran, Olympic Village, Village Square, Central Building, Allameh Tabataba'i University
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4473 7510
Email
soheila_ghomian@yahoo.com

5

Recruitment center
Name of recruitment center
Shahed University
Full name of responsible person
Soheila Ghomian
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
info@shahed.ac.ir

6

Recruitment center
Name of recruitment center
Amir Kabir University
Full name of responsible person
Soheila Ghomian
Street address
Hafez Street, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۱۶۳۴۳۱۱
Phone
+98 21 6695 9149
Email
info@aut.ac.ir

7

Recruitment center
Name of recruitment center
Sharif University of Technology
Full name of responsible person
Soheila Ghomian
Street address
Sharif University of Technology, Azadi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۵۸۸۸۹۶۹۴
Phone
+98 21 6601 3126
Email
prm@sharif.ir

8

Recruitment center
Name of recruitment center
Kharazmi University
Full name of responsible person
Soheila Ghomian
Street address
Until the Enghelab, Shahid Mofteh Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۹۱۱۱۵۷۱۹
Phone
+98 21 8832 9220
Email
info@khu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Soheila Ghomian
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
50
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
Shahed University
Full name of responsible person
Soheila Ghomian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
Soheila_Ghomian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Soheila Ghomian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
Soheila_Ghomian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Soheila Ghomian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
Soheila_Ghomian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this research will be presented in paper form
When the data will become available and for how long
About a year
To whom data/document is available
Psychologists
Under which criteria data/document could be used
Certain conditions are not considered
From where data/document is obtainable
Soheila Ghomian
What processes are involved for a request to access data/document
It will be answered by email
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