Protocol summary

Study aim
Comparing Challenge and Interpretation in Intensive Short-Term Dynamic Psychotherapy (ISTDP)
Design
A three-group randomized controlled trial design was used. The participants were patients with DSM-5 SAD determined by a diagnostic interview. Notices offering involvement in research were circulated throughout the university to attract participants. The volunteer participants, who had the entrance criteria were randomly assigned to one of three groups using the selection of one from 42 envelopes, including numbers of 1, 2, and 3; blinded to randomization (unaware if they had been randomized to which group). The three groups were standard ISTDP, no challenge ISTDP (NC-ISTDP) and a wait-list control.
Settings and conduct
The study was a therapeutic intervention, which was done in the treatment office of the Faculty of Humanities and Social Sciences at the University of Kurdistan; The participants, assigned to one of three groups using the selection of one from 42 envelopes, including numbers of 1, 2, and 3; blinded to randomization (unaware if they had been randomized to which group). The three groups were standard ISTDP, no challenge ISTDP (NC-ISTDP) and a wait-list control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Social Anxiety Disorder, Student in the University of Kurdistan Exclusion criteria: history of psychosis, substance abuse, any simultaneous treatment for mental or somatic disorder
Intervention groups
Challenge Group Vs. Interpretation Group, and comparing the Control Group
Main outcome variables
The Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR)-Persian version; Diagnostic interview based on the DSM-5 criteria for SAD

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181208041890N1
Registration date: 2019-09-16, 1398/06/25
Registration timing: retrospective

Last update: 2019-09-16, 1398/06/25
Update count: 0
Registration date
2019-09-16, 1398/06/25
Registrant information
Name
Fateh Rahmani
Name of organization / entity
University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4600
Email address
f.rahmani@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
2015-04-04, 1394/01/15
Actual recruitment end date
2016-02-09, 1394/11/20
Trial completion date
2016-02-09, 1394/11/20
Scientific title
Comparing the effects of challenge and interpretation in treating patients with social anxiety disorder by intensive short-term dynamic psychotherapy; a process and outcome research
Public title
Challenging the role of challenge in intensive short-term dynamic psychotherapy for Social Anxiety Disorder: a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Social Anxiety Disorder Student of the University of Kurdistan
Exclusion criteria:
History of Psychosis substance use Being under treatment
Age
From 18 years old to 34 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 41
Actual sample size reached: 41
Randomization (investigator's opinion)
Randomized
Randomization description
The volunteer participants, who had the entrance criteria were randomly assigned to one of three groups using the selection of one from 42 envelopes, including numbers of 1, 2, and 3; blinded to randomization (unaware if they had been randomized to which group). The three groups were standard ISTDP, no challenge ISTDP (NC-ISTDP) and a wait-list control.
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
National Committee of Ethics in Biomedical Researches
Street address
University of Kurdistan Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.UOK.REC.1397.004

Health conditions studied

1

Description of health condition studied
Social Anxiety Disorder (Social Phobia)
ICD-10 code
F40.1
ICD-10 code description
Social Phobias

Primary outcomes

1

Description
The Subjects Score in The Liebowitz Social Anxiety Scale
Timepoint
Before-After Treatment and 6 Months Follow up
Method of measurement
The Liebowitz Social Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
The standard challenge-based central dynamic sequence of ISTDP including eight phases:Phase 1 (inquiry); Phase 2 (pressure); Phase 3 (challenge); Phase 4 (transference resistance); Phase 5 (direct access to the unconscious); Phase 6 (systematic analysis of the transference); Phase 7 (dynamic exploration into the unconscious); Phase 8 (consolidation). Standard ISTDP focused on accessing and experiencing the unconscious feelings through clarification, challenge to resistance and head on collision with resistance. For each group, a ten-session protocol of ISTDP for SAD was used. The first four sessions aimed at making the dynamic unconscious accessible. Sessions 5 to a maximum of eight focused on uncovering the pathogenic emotional forces underling SAD through the ISTDP formulation of unprocessed feelings and defenses leading to symptoms. Termination focused on ending the therapist-patient relationship.
Category
Treatment - Other

2

Description
The non-challenge-based central dynamic sequence of ISTDP including eight phases:Phase 1 (inquiry/preparation); Phase 2 (pressure); Phase 3 (interpretation/analysis); Phase 4 (transference resistance); Phase 5 (direct access to the unconscious); Phase 6 (systematic analysis of the transference); Phase 7 (dynamic exploration into the unconscious); Phase 8 (consolidation/analysis). The non-challenge-based ISTDP used clarification, recapitulation, and head on collision but did not use challenge. For each group, a ten-session protocol of ISTDP for SAD was used. The first four sessions aimed at making the dynamic unconscious accessible. Sessions 5 to a maximum of eight focused on uncovering the pathogenic emotional forces underling SAD through the ISTDP formulation of unprocessed feelings and defenses leading to symptoms. Termination focused on ending the therapist-patient relationship.
Category
Treatment - Other

3

Description
Control group: The Control Group; this group receive no intervention until the end of treatment. Then they underwent treatment for ethical reasons, But, the results were not considered in the research.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The University of Kurdistan, Recall from Students
Full name of responsible person
Fateh Rahmani
Street address
University Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87 3366 4600
Email
F.rahmani@uok.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
Fateh Rahmani
Street address
University Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87 3366 4600
Email
F.rahmani@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no
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 Kurdistan
Full name of responsible person
Fateh Rahmani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87336646008
Email
F.rahmani@uok.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Fateh Rahmani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87336646008
Email
F.rahmani@uok.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Fateh Rahmani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87336646008
Email
F.rahmani@uok.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of Data will be shared.
When the data will become available and for how long
After Publishing the article.
To whom data/document is available
All the researchers who work in university research centers.
Under which criteria data/document could be used
Every required analysis for meta-analyses
From where data/document is obtainable
Contact the responsible researcher
What processes are involved for a request to access data/document
To introduce the research team, their works and what they do to the data
Comments
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