Aims: This study evaluates intensive short-term dynamic psychotherapy (ISTDP) as a treatment for MUP outpatients by comparing it to the established evidence-based treatment cognitive behavioral therapy (CBT) in a randomized clinical trial. The authors hypothesized insignificant differences in ISTDP relative to CBT.
Design: This study was a randomized controlled trial with an allocation ratio of 1:1 for CBT and ISTDP.
Method: A total of 341 adults with MUP were randomly assigned to 16 sessions of individual manualized CBT (N = 164) or ISTDP (N = 177). The groups were assessed at baseline, after 16 weeks of treatment, and at the three-month follow-up.
Interventions: Participants are randomly allocated to either CBT or ISTDP. Both are individual psychotherapies encompassing 16 sessions within 22 weeks.
Randomization: Patients were randomized in blocks by a computer algorithm. Block size was randomly chosen to include either three or six patients.
Blinding: The research assessor administering the observer-rated scales was blinded to the group assignment at baseline and three-month follow-up.
Outcome measures: The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale (NPRS). The secondary outcomes were psychological distress, depression, and cognitive variables. The cognitive variables included self-efficacy, catastrophizing, and coping strategies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091329810N1
Registration date:2016-11-09, 1395/08/19
Registration timing:na
Last update:
Update count:0
Registration date
2016-11-09, 1395/08/19
Registrant information
Name
Behzad Chavooshi
Name of organization / entity
Neuroscience Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2265 6623
Email address
b.chavooshi@bmsu.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research of Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial comparing cognitive behavior therapy and intensive short-term dynamic psychotherapy for medically unexplained pain
Public title
Comparing the effectiveness of cognitive behavioral therapy and intensive short-term dynamic psychotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: "18–45 years of age"; "at least one MUP with a duration of six months"; "fluency in Farsi".
Exclusion criteria: "acute drug/alcohol abuse"; "psychotic disorder"; "bipolar disorder"; "anorexia nervosa disorder"; "acute suicidality"; "pregnancy".
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
341
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will randomize in blocks by a computer algorithm. Block size was randomly chosen to include either three or six patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Baqiyatallah University of Medical Sciences
Street address
Mollasadra Avenue, Vanak square
City
Tehran
Postal code
Tehran
Approval date
2013-07-01, 1392/04/10
Ethics committee reference number
130/1720/d/91
Health conditions studied
1
Description of health condition studied
Pain disorders related to psychological factors
ICD-10 code
F45.4
ICD-10 code description
A category of psychiatric disorders which are characterized by the presence of physical symptoms that suggest a medical condition but are not fully explained by any known medical reasons. Disorders characterized by bodily symptoms caused by psychological
Primary outcomes
1
Description
Pain intensity
Timepoint
at Baseline, Post-treatment (week 16) and at the Three-month Follow-up
Method of measurement
Numerical Pain Rating Scale (NPRS)
Secondary outcomes
1
Description
Secondary outcome measure 2: anxiety
Timepoint
We will take the measurement at three timepoints: at a baseline assessment (before randomization); immediately post of treatment (after 16 sessions); and after three months of follow-up.
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
2
Description
Secondary outcome measure 1: depression
Timepoint
We will take the measurement at three timepoints: at a baseline assessment (before randomization); immediately post of treatment (after 16 sessions); and after three months of follow-up.
Method of measurement
Beck Depression Inventory-II (BDI-II)
3
Description
Secondary outcome measure 3: catastrophizing
Timepoint
We will take the measurement at three timepoints: at a baseline assessment (before randomization); immediately post of treatment (after 16 sessions); and after three months of follow-up.
Method of measurement
Pain Catastrophizing Scale (PCS)
4
Description
Secondary outcome measure 4: self-efficacy
Timepoint
We will take the measurement at three timepoints: at a baseline assessment (before randomization); immediately post of treatment (after 16 sessions); and after three months of follow-up.
Method of measurement
Chronic Pain Self-Efficacy Scale (CPSS)
5
Description
Secondary outcome measure 5: chronic pain coping
Timepoint
We will take the measurement at three timepoints: at a baseline assessment (before randomization); immediately post of treatment (after 16 sessions); and after three months of follow-up.
Method of measurement
Chronic Pain Coping Inventory (CPCI)
Intervention groups
1
Description
Control group: cognitive behavioral therapy is a short-term, goal-oriented psychotherapy treatment that takes a hands-on, practical approach to problem-solving. Its goal is to change patterns of thinking or behavior that are behind people's difficulties, and so change the way they feel.
Category
Behavior
2
Description
Intervention group: Intensive Short-Term Dynamic Psychotherapy (ISTDP) is a unique form of psychodynamic treatment. ISTDP interventions are specifically designed to experience the emotion cognitively, and somatic matorically (physically in the body).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Dr. Mehdi Saberi
Street address
Tehran Province, Tehran, Mollasadra Avenue
City
Mollssadra Avenue, Vanak square
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Hedayat Sahraei
Street address
Artesh Boulevard, Aghdasieh
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Neuroscience Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mehdi Saberi
Position
Ph.D. / Senior researcher
Other areas of specialty/work
Street address
Artesh Boulevard, Aghdasieh
City
Tehran
Postal code
1435915371
Phone
+98 21 2265 6623
Fax
+98 22656722
Email
m.saberi@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neuroscience Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Behzad Chavooshi
Position
Ph.D.
Other areas of specialty/work
Street address
Artesh Boulevard, Aghdasieh
City
Tehran
Postal code
1435915371
Phone
+98 21 2265 6722
Fax
+98 22656722
Email
"b.chavooshi@yahoo.com"; "b.chavooshi@bmsu.ac.ir"
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neuroscience Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Behzad Chavooshi
Position
Ph.D.
Other areas of specialty/work
Street address
Artesh Boulevard, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 2265 6623
Fax
+98 22656722
Email
b.chavooshi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)