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iTreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder (iTREATOCD)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
ICBT
Sponsored by
Pedro Morgado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring obsessive-compulsive disorder, ocd, neuroimaging, emotion regulation, internet-based cognitive behavioral therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders YBOCS score ≥ 16 Psychotropic medication, if stable for at least 2 months prior to inclusion and if the dosage is maintained thoughout the study Have the resources to access the online intervention (internet access; computer or tablet) Exclusion Criteria: MRI contraindications Prior medical history of neurological disorders or traumatic brain injury Having performed CBT treatment for OCD in the last 2 years Undergoing any psychological treatment Suicidal ideation Current alcohol or drug abuse

Sites / Locations

  • Life and Health Sciences Research Institute, School of Medicine, University of MinhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCBT intervention

Wait list

Arm Description

Participants will enroll in an internet-based cognitive behavioral program during 14 weeks. The program comprises 10 modules and three videoconferencing psychotherapy sessions.

Participants will be enrolled in the iCBT program after 14 weeks

Outcomes

Primary Outcome Measures

Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Psychometric scale to assess obsessive-compulsive symptoms

Secondary Outcome Measures

Obsessive-Compulsive Inventory- Revised
Psychometric scale to assess obsessive-compulsive symptoms
Hamilton Anxiety Scale
Psychometric scale to assess anxiety symptoms
Hamilton Depression Scale
Psychometric scale to assess depression symptoms
Perceived Stress Scale
Psychometric scale to assess stress symptoms
Emotion Regulation Questionnaire
Psychometric scale to assess cognitive regulation and emotional suppression capabilities
Difficulties in Emotion Regulation Scale
Psychometric scale to assess emotion deregulation
Positive and Negative Affect Schedule
Psychometric scale to assess affect
Depression Anxiety Stress scale
Psychometric scale to assess symptoms of anxiety, depression and stress
NEO Five-Factor Inventory
Psychometric scale to assess personality traits
Treatment Acceptability/Adherence Scale
Psychometric scale to assess treatment adherence
University of Rhode Island Change Assessment Scale
Psychometric scale to assess motivation to change

Full Information

First Posted
May 16, 2023
Last Updated
June 6, 2023
Sponsor
Pedro Morgado
Collaborators
Hospital de Braga, ICVS - Life and Health Sciences Research Institute, Clinical Academic Center (2CA), Associação Centro de Medicina P5 (ACMP5)
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1. Study Identification

Unique Protocol Identification Number
NCT05906069
Brief Title
iTreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder
Acronym
iTREATOCD
Official Title
iTreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy From Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Morgado
Collaborators
Hospital de Braga, ICVS - Life and Health Sciences Research Institute, Clinical Academic Center (2CA), Associação Centro de Medicina P5 (ACMP5)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the current study, the investigators will characterize obsessive-compulsive disorder (OCD) patients and healthy controls with a comprehensive clinical and neuroimaging assessment, focusing on the basic psychological processes related and on the neurobiological underpinnings of emotion regulation (ER). After a baseline assessment, the investigators will implement an internet-based cognitive behavioral therapy (iCBT) protocol and assess its efficacy on the modulation of ER and OCD severity. Specifically, the investigators will (1) examine to what extent the iCBT intervention modulates ER and the associated neurobiological mechanisms and (2) identify candidate biomarkers of successful treatment response.
Detailed Description
Sixty patients and sixty controls will be recruited at Hospital de Braga, Braga, Portugal (sample size estimated based on a previous systematic review). A power analysis indicated that a sample of 24 individuals per group is adequate to detect an effect size of d=.89, with a Type I error of .05 and a statistical power of .85. A final sample of 30 individuals was defined to account for a 20% dropout rate during the intervention. All participants will be assessed with a comprehensive psychological and clinical characterization. Following the baseline assessment, OCD patients will be randomly allocated to the intervention (iCBT intervention) or the control group (waiting list). The iCBT intervention will consist of a structured program comprising 10 modules with text and video content, as well as 3 videoconferencing psychotherapy sessions. After the intervention/waiting list, patients will be re-assessed with the clinical and psychological assessment. In order to characterize the patterns of brain activation in OCD patients during an emotion regulation task in comparison to healthy controls and to identify potential neurobiological markers of symptoms' improvement, a multimodal neuroimaging assessment will also be performed. The task encompasses the presentation of pictures (fearful, neutral and OCD-related stimuli) under two conditions: the instruction to view the pictures naturally ('observe'); or to apply cognitive reappraisal techniques to decrease any negative affective state caused by the stimuli ('regulate'). Fear and OCD-related pictures are presented during both conditions; neutral pictures only during 'observe'. After each stimulus, the level of distress will be assessed by a self-report rating scale. In the baseline assessment, brain activation patterns (with whole-brain and region of interest approaches) will be compared between OCD and healthy controls in both task conditions. After intervention, emotion regulation ability and the underlying neurobiological mechanisms will be compared between the 'intervention' and 'waiting list' groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
obsessive-compulsive disorder, ocd, neuroimaging, emotion regulation, internet-based cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
OCD patients will be randomly allocated into two groups - iCBT group (experimental group) and wait list group (comparator control group). The experimental group will receive a 14-week iCBT intervention program and the wait list group will receive the same intervention but at a later time.
Masking
Outcomes Assessor
Masking Description
The psychologist performing the assessment of the main psychometric outcomes will be blind to the group allocation of each participant.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCBT intervention
Arm Type
Experimental
Arm Description
Participants will enroll in an internet-based cognitive behavioral program during 14 weeks. The program comprises 10 modules and three videoconferencing psychotherapy sessions.
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Participants will be enrolled in the iCBT program after 14 weeks
Intervention Type
Behavioral
Intervention Name(s)
ICBT
Intervention Description
The intervention will consist in a structured internet-based intervention with 10 modules that will combine cognitive-behavioral techniques to improve obsessive-compulsive symptoms as well as the emotion regulation ability.
Primary Outcome Measure Information:
Title
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
Psychometric scale to assess obsessive-compulsive symptoms
Time Frame
immediately before and immediately after intervention/waitlist
Secondary Outcome Measure Information:
Title
Obsessive-Compulsive Inventory- Revised
Description
Psychometric scale to assess obsessive-compulsive symptoms
Time Frame
baseline; 4 weeks after beginning intervention/waitlist; 8 weeks after beginning; 12 weeks after beginning intervention/waitlist and immediately after intervention/waitlist
Title
Hamilton Anxiety Scale
Description
Psychometric scale to assess anxiety symptoms
Time Frame
immediately before and immediately after intervention/waitlist
Title
Hamilton Depression Scale
Description
Psychometric scale to assess depression symptoms
Time Frame
immediately before and immediately after intervention/waitlist
Title
Perceived Stress Scale
Description
Psychometric scale to assess stress symptoms
Time Frame
immediately before and immediately after intervention/waitlist
Title
Emotion Regulation Questionnaire
Description
Psychometric scale to assess cognitive regulation and emotional suppression capabilities
Time Frame
immediately before and immediately after intervention/waitlist
Title
Difficulties in Emotion Regulation Scale
Description
Psychometric scale to assess emotion deregulation
Time Frame
immediately before and immediately after intervention/waitlist
Title
Positive and Negative Affect Schedule
Description
Psychometric scale to assess affect
Time Frame
immediately before and immediately after intervention/waitlist
Title
Depression Anxiety Stress scale
Description
Psychometric scale to assess symptoms of anxiety, depression and stress
Time Frame
baseline; every week during intervention/wait list (up to 14 weeks) and immediately after intervention/waitlist
Title
NEO Five-Factor Inventory
Description
Psychometric scale to assess personality traits
Time Frame
baseline
Title
Treatment Acceptability/Adherence Scale
Description
Psychometric scale to assess treatment adherence
Time Frame
immediately after intervention
Title
University of Rhode Island Change Assessment Scale
Description
Psychometric scale to assess motivation to change
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders YBOCS score ≥ 16 Psychotropic medication, if stable for at least 2 months prior to inclusion and if the dosage is maintained thoughout the study Have the resources to access the online intervention (internet access; computer or tablet) Exclusion Criteria: MRI contraindications Prior medical history of neurological disorders or traumatic brain injury Having performed CBT treatment for OCD in the last 2 years Undergoing any psychological treatment Suicidal ideation Current alcohol or drug abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Morgado, M.D, Ph.D.
Phone
+351 253 604 931
Email
pedromorgado@med.uminho.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Mafalda Sousa, M., Sc.
Email
id9534@alunos.uminho.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Morgado, M.D, Ph.D.
Organizational Affiliation
Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Life and Health Sciences Research Institute, School of Medicine, University of Minho
City
Braga
State/Province
Gualtar
ZIP/Postal Code
4710-057
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Morgado, M.D, Ph.D.
Phone
00351 253 604 931
Email
pedromorgado@med.uminho.pt
First Name & Middle Initial & Last Name & Degree
Mafalda Sousa, M. Sc.
Email
id9534@alunos.uminho.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

iTreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder

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