Protocol summary
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Study aim
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The present study aims to compare the effectiveness of "inference-based therapy in combination with pharmacotherapy with selective serotonin reuptake inhibitors " to "selective serotonin reuptake inhibitors monotherapy" in the treatment of patients with obsessive-compulsive disorder with good insight.
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Design
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A clinical trial, with parallel groups, purposive sampling, phase 2 on 40 patients. Simple randomization was done.
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Settings and conduct
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The trial was conducted at Ebnesina Hospital in Shiraz. Participants were treated in two treatment groups.
SSRIs were started at the lowest dose within the FDA-approved dose range and gradually increased, and three drugs were used: fluoxetine (ABIDI), sertraline (ABIDI), and fluvoxamine (Tehrandaru).
IBT was also applied based on the IBT protocol during 24 45-minute sessions. The focus of this therapy is on eliminating obsessive doubt by overcoming the inferential confusion process. For this purpose, patients begin to change their obsessive narratives to non-obsessive narratives through therapeutic techniques during treatment. Inference-based therapy consists of 3 basic stages: education, intervention, and stabilization.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1. A primary diagnosis of OCD with good insight 2. Minimum level of education: High school diploma 3. Age between 18 to 50.4. Absence of suicidal risk/ current suicidal ideation.
Exclusion criteria: 1. current Substance abuse 2. comorbid personality disorders, psychotic disorders, an organic mental disorder, a pervasive developmental disorder or mental retardation 3. evidence or diagnosis of bipolar disorder.
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Intervention groups
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There were 2 levels of intervention:
1. Pharmacotherapy with SSRI and inference-based therapy
2. pharmacotherapy with SSRI
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Main outcome variables
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The severity of the obsessions and compulsions
General information
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Reason for update
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Shortening the title of article in order to submit in journal
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231029059893N1
Registration date:
2023-11-25, 1402/09/04
Registration timing:
prospective
Last update:
2026-04-18, 1405/01/29
Update count:
2
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Registration date
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2023-11-25, 1402/09/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-11, 1402/08/20
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Expected recruitment end date
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2024-11-20, 1403/08/30
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Actual recruitment start date
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2023-12-02, 1402/09/11
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Actual recruitment end date
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2024-12-24, 1403/10/04
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Trial completion date
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2025-06-27, 1404/04/06
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Scientific title
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The Effectiveness of Inference-based Therapy Combined with Pharmacotherapy with Selective Serotonin Reuptake Inhibitors Compared to Selective Serotonin Reuptake Inhibitors Monotherapy in Treating Patients with Obsessive-Compulsive Disorder with Good Insight
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Public title
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Comparing the effect of "inference-based therapy and treatment with selective serotonin reuptake inhibitors" to "selective serotonin reuptake inhibitors" on obsessive-compulsive disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
A primary diagnosis of obsessive compulsive disorder with good insight
Minimum level of education :High school diploma
Age between 18 to 50
Absence of suicidal risk/ current suicidal ideation
Exclusion criteria:
current substance abuse
comorbid personality disorders, psychotic disorders, an organic mental disorder, a pervasive developmental disorder or mental retardation
evidence or diagnosis of bipolar disorder.
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-04-18, 1402/01/29
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Ethics committee reference number
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IR.US.PSYEDU.REC.1402.022
Health conditions studied
1
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Description of health condition studied
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Obsessive Compulsive Disorder
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ICD-10 code
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F42.2
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ICD-10 code description
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Mixed obsessional thoughts and acts
Primary outcomes
1
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Description
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The patient's score on Yale-Brown Obsessive-Compulsive Scale
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Yale-Brown Obsessive-Compulsive Scale
Secondary outcomes
1
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Description
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The patient's score on the World Health Organization Quality of Life questionnaire - brief version
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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World Health Organization Quality of Life questionnaire - brief version
2
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Description
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The patient's score on Beck Depression Inventory
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Beck Depression Inventory
3
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Description
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The patient's score on Beck Anxiety Inventory
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Beck Anxiety Inventory
4
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Description
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The patient's score on Inferential Confusion Questionnaire, Extended Version
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Inferential Confusion Questionnaire, Extended Version
Intervention groups
1
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Description
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First intervention group: Pharmacotherapy with selective serotonin reuptake inhibitors and inference-based therapy Inference-based therapy is a cognitive therapy that takes place in 24 sessions of 45 minutes over 6 months. The focus of this therapy is on resolving obsessive doubt by overcoming the process of inferential confusion. To this end, during treatment, patients begin to change their obsessive narratives to non-obsessive narratives through therapeutic techniques. Inference-based therapy consists of 3 basic steps: Education, Interventions & Consolidation. The Education phase consists of 4 steps: 1. Educating that most of OCD symptoms are caused by doubt 2. Focusing on reasoning before doubt (inferential confusion) and showing clients that doubt or obsession does not arise without a prelude 3. Exploring how obsessive doubt derives its power and value from a compelling narrative that logically leads to doubt 4. Addressing the selectivity nature of obsessions in OCD by introducing the construct of feared self. The intervention phase consists of: 1. Demonstrating the client that there is no direct here-and-now evidence that would support the OCD doubt & therefore, the OCD story is produced entirely subjectively 2. Demonstrating the client that since obsessive doubt arises purely from within the person and not an external source, it is %100 irrelevant to here and now 3. Assisting the client recognize the exact moment when they have left the world of senses and entered the realm of imagination 4. Describing how obsessive doubt is always false -due to its opposition to reality And finally, the Consolidation phase:1. Encouraging the client to narrate a non-obsessive story 2.Introducing the client to many OCD tricks that make it seem as if the obsessive doubt is connected to reality. 3.Highlighting the selective nature of obsessive doubt besides the vulnerable self-theme that exists in doubt 4. Moving towards a life without OCD, developing a method to enable maintenance of gains and prevention of relapse. Pharmacotherapy was performed with three drugs, fluoxetine(ABIDI), sertraline(ABIDI), and fluvoxamine(Tehrandarou), which are FDA-approved for the treatment of OCD in terms of effectiveness and side effects. To minimize the side effects of the drugs, such as gastrointestinal side effects, dizziness, and other symptoms, treatment with SSRIs was started at a very low dose and over time, depending on the patient's tolerance to the drug side effects, the dose of the drugs was increased by the psychiatrist every 4-7 days until the target dose was achieved. A specific dose has been considered for each of the 4 drugs used: Recommended dose of sertraline: 50 to 200 mg per day Recommended dose of fluoxetine: 20 to 60 mg per day Recommended dose of fluvoxamine: 100 to 300 mg per day All drugs were used once a day, except for fluvoxamine, which was used twice a day due to its short half-life.
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Category
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Treatment - Other
2
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Description
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Second intervention group: Pharmacotherapy with selective serotonin reuptake inhibitors Pharmacotherapy was performed with three drugs, fluoxetine(ABIDI), sertraline(ABIDI), and fluvoxamine(Tehrandarou), which are FDA-approved for the treatment of OCD in terms of effectiveness and side effects. To minimize the side effects of the drugs, such as gastrointestinal side effects, dizziness, and other symptoms, treatment with SSRIs was started at a very low dose and over time, depending on the patient's tolerance to the drug side effects, the dose of the drugs was increased by the psychiatrist every 4-7 days until the target dose was achieved. A specific dose has been considered for each of the 4 drugs used: Recommended dose of sertraline: 50 to 200 mg per day Recommended dose of fluoxetine: 20 to 60 mg per day Recommended dose of fluvoxamine: 100 to 300 mg per day All drugs were used once a day, except for fluvoxamine, which was used twice a day due to its short half-life.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz university
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Despite attempts to anonymize data, there may be a risk of re-identification participants, which is unethical and violates the researcher's commitment to participants. There is also a concern that the original data may be valuable for the researcher's own future research.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available