Obsessive-Compulsive Disorder Clinical Trial
Official title:
Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement in Obsessive-Compulsive Disorder
Verified date | November 2017 |
Source | Utah State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study was to evaluate whether integrating Acceptance and Commitment Therapy (ACT) with Exposure and Response Prevention (ERP) increases the acceptability, tolerability, and adherence with ERP techniques relative to ERP without ACT. Fifty-eight adults with a DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2 hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral observations were conducted at pre- and post-test, and at 6 month follow-up. Specific hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability, and show higher quantity and quality of completed self-directed ERP assignments, relative to patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.
Status | Completed |
Enrollment | 58 |
Est. completion date | January 9, 2017 |
Est. primary completion date | January 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Current DSM-IV-TR principal diagnosis of OCD for at least 1 year - Willing to attend all 16 therapy sessions - Fluent in English - No previous Cognitive Behavior Therapy or Acceptance and Commitment Therapy for OCD - If on medication for OCD, willing to remain at a fixed dose while participating in the study Exclusion Criteria: - Current severe depression or suicidal ideation - Current substance abuse or dependence - Current mania, psychosis, or borderline or schizotypal personality disorder |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Utah State University | Logan | Utah |
Lead Sponsor | Collaborator |
---|---|
Utah State University | International OCD Foundation, University of North Carolina, Chapel Hill |
United States,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 8 weeks | Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74. | Posttreatment (8 weeks after Baseline) | |
Primary | Change from Posttreatment Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 6 months | Global OCD severity was measured using the Y-BOCS, a semi-structured interview that includes a symptom checklist and 10-item severity scale. The checklist is first used to identify the patient's particular obsessions and compulsions. The severity scale then assesses the main obsessions (items 1-5) and compulsions (items 6-10) on the following five parameters: (a) time, (b) interference, (c) distress, (d) resistance, and (e) degree of control. The clinician rates each item from 0 (no symptoms) to 4 (extreme) based on the past week. The 10 items are added to produce a total severity score that ranges from 0 to 40. The Y-BOCS is the most widely used measure of OCD severity and has satisfactory psychometric properties. The internal consistency (Cronbach's alpha) of the pre-treatment Y-BOCS in the present sample was .74. | Follow-up (6 months after the end of treatment) | |
Secondary | Change from Baseline Beck Depression Inventory II (BDI-II) at 8 weeks | The BDI-II is a 21-item self-report scale that assesses the severity of affective, cognitive, motivational, vegetative, and psychomotor components of depression. Scores of 10 or less are considered normal; scores of 20 or greater suggest the presence of clinical depression. The BDI has excellent reliability and validity and is widely used in clinical research. In the present sample, the pre-treatment BDI had a Cronbach's alpha of .93. | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Beck Depression Inventory II (BDI-II) at 6 months | The BDI is a 21-item self-report scale that assesses the severity of affective, cognitive, motivational, vegetative, and psychomotor components of depression. Scores of 10 or less are considered normal; scores of 20 or greater suggest the presence of clinical depression. The BDI has excellent reliability and validity and is widely used in clinical research. In the present sample, the pre-treatment BDI had a Cronbach's alpha of .93. | Follow-up (6 months after the end of treatment) | |
Secondary | Change from Baseline Acceptance and Action Questionnaire - II (AAQ-II) at 8 weeks | The AAQ-II is a 7-item 7-point Likert-type measure of experiential avoidance/psychological inflexibility. The items reflect: (a) unwillingness to experience unwanted emotions and thoughts, and (b) the inability to be in the present moment and behave according to value-directed actions when experiencing unwanted psychological events. The AAQ-II shows good psychometric properties (mean alpha of .88). In present sample, the pre-treatment AAQ-II had a Cronbach's alpha of .87. | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Acceptance and Action Questionnaire - II (AAQ-II) at 6 months | The AAQ-II is a 7-item 7-point Likert-type measure of experiential avoidance/psychological inflexibility. The items reflect: (a) unwillingness to experience unwanted emotions and thoughts, and (b) the inability to be in the present moment and behave according to value-directed actions when experiencing unwanted psychological events. The AAQ-II shows good psychometric properties (mean alpha of .88). In present sample, the pre-treatment AAQ-II had a Cronbach's alpha of .87. | Follow-up (6 months after the end of treatment) | |
Secondary | Session-level Change in Acceptance and Action Questionnaire - II (AAQ-II) at each session | The AAQ-II is a 7-item 7-point Likert-type measure of experiential avoidance/psychological inflexibility. The items reflect: (a) unwillingness to experience unwanted emotions and thoughts, and (b) the inability to be in the present moment and behave according to value-directed actions when experiencing unwanted psychological events. The AAQ-II shows good psychometric properties (mean alpha of .88). In present sample, the pre-treatment AAQ-II had a Cronbach's alpha of .87. | Sessions 1-16 (Twice per week for 8 weeks following Baseline) | |
Secondary | Change from Baseline Distress Tolerance Scale (DTS) at 8 weeks | The DTS is composed of 14 items answered on 5-point Likert-type scales ranging from 1, strongly agree, to 5, strongly disagree, evaluating participants' ability to experience and endure negative emotional states. Greater scores reflect higher levels of distress tolerance. This scale has good psychometric properties, including high internal consistency (a=.89) and appropriate convergence with other self-report ratings of affective distress and regulation. In addition, the DTS has demonstrated adequate 6-month test-retest reliability (r=.61). In the present sample, the pre-treatment DTS had a Cronbach's alpha of .94. | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Distress Tolerance Scale (DTS) at 6 months | The DTS is composed of 14 items answered on 5-point Likert-type scales ranging from 1, strongly agree, to 5, strongly disagree, evaluating participants' ability to experience and endure negative emotional states. Greater scores reflect higher levels of distress tolerance. This scale has good psychometric properties, including high internal consistency (a=.89) and appropriate convergence with other self-report ratings of affective distress and regulation. In addition, the DTS has demonstrated adequate 6-month test-retest reliability (r=.61). In the present sample, the pre-treatment DTS had a Cronbach's alpha of .94. | Follow-up (6 months after the end of treatment) | |
Secondary | Change from Baseline Interpretation of Intrusions Inventory (III) at 8 weeks | The III is a semi-idiographic measure designed to assess negative appraisals of intrusive thoughts. The respondent reads a set of instructions that includes examples of intrusive thoughts (e.g., images of the baby lying dead in his crib, an impulse to shake the infant very hard) and then is asked to identify one or two examples of his or her own intrusions. The respondent then identifies the extent of his or her agreement with 31 items concerning various negative appraisals of these intrusions (e.g., "I would be a better person if I didn't have this thought"). Although 3 theoretically derived subscales were initially proposed: (a) importance of thoughts, (b) control of thoughts, and (c) responsibility, data suggests that only a single factor exists. The internal consistency of the pre-treatment III in the present sample was .94. | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Interpretation of Intrusions Inventory (III) at 6 months | The III is a semi-idiographic measure designed to assess negative appraisals of intrusive thoughts. The respondent reads a set of instructions that includes examples of intrusive thoughts (e.g., images of the baby lying dead in his crib, an impulse to shake the infant very hard) and then is asked to identify one or two examples of his or her own intrusions. The respondent then identifies the extent of his or her agreement with 31 items concerning various negative appraisals of these intrusions (e.g., "I would be a better person if I didn't have this thought"). Although 3 theoretically derived subscales were initially proposed: (a) importance of thoughts, (b) control of thoughts, and (c) responsibility, data suggests that only a single factor exists. The internal consistency of the pre-treatment III in the present sample was .94. | Follow-up (6 months after the end of treatment) | |
Secondary | Session-level Change in Interpretation of Intrusions Inventory (III) at each session | The III is a semi-idiographic measure designed to assess negative appraisals of intrusive thoughts. The respondent reads a set of instructions that includes examples of intrusive thoughts (e.g., images of the baby lying dead in his crib, an impulse to shake the infant very hard) and then is asked to identify one or two examples of his or her own intrusions. The respondent then identifies the extent of his or her agreement with 31 items concerning various negative appraisals of these intrusions (e.g., "I would be a better person if I didn't have this thought"). Although 3 theoretically derived subscales were initially proposed: (a) importance of thoughts, (b) control of thoughts, and (c) responsibility, data suggests that only a single factor exists. The internal consistency of the pre-treatment III in the present sample was .94. | Sessions 1-16 (twice per week for 8 weeks following Baseline) | |
Secondary | Change from Baseline Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 8 weeks | The BAFT is a self-report measure of cognitive fusion with anxious thoughts and feelings. It consists of 16 items representing different thoughts which are rated on a 7-point Likert-type scale ranging from 1 (not at all believable) to 7 (completely believable) to the extent that the individual believes in them. A hierarchical factor structure of the BAFT with three lower order factors and one hierarchical factor was found. The three lower order factors were labeled Somatic Concerns (fusion with somatic concerns), Emotion Regulation (fusion with excessive struggle with and control of emotions), and Negative Evaluation (fusion with negative evaluation of anxious thoughts and feelings). The internal consistency of the total pre-treatment BAFT in the present sample was .86. Individual subscale internal consistencies ranged from .72 to .77. | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 6 months | The BAFT is a self-report measure of cognitive fusion with anxious thoughts and feelings. It consists of 16 items representing different thoughts which are rated on a 7-point Likert-type scale ranging from 1 (not at all believable) to 7 (completely believable) to the extent that the individual believes in them. A hierarchical factor structure of the BAFT with three lower order factors and one hierarchical factor was found. The three lower order factors were labeled Somatic Concerns (fusion with somatic concerns), Emotion Regulation (fusion with excessive struggle with and control of emotions), and Negative Evaluation (fusion with negative evaluation of anxious thoughts and feelings). The internal consistency of the total pre-treatment BAFT in the present sample was .86. Individual subscale internal consistencies ranged from .72 to .77. | Follow-up (6 months after the end of treatment) | |
Secondary | Change from Baseline Obsessive Beliefs Questionnaire (OBQ) at 8 weeks | The OBQ is a 44-item self-report questionnaire developed to assess a variety of dysfunctional beliefs thought to underlie OCD symptoms. Three factor analytically derived subscales correspond to the following domains of obsessive beliefs: (a) overestimates of threat and responsibility for harm, (b) importance and control of intrusive thoughts, and (c) perfectionism and the need for certainty. Participants rate their agreement with each of 44 statements from 1 (disagree very much) to 7 (agree very much). The instrument possesses good validity and internal consistency, and has been widely studied in clinical and nonclinical samples. Cronbach alphas for the subscales ranged from .89 to .91. | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Obsessive Beliefs Questionnaire (OBQ) at 6 months | The OBQ is a 44-item self-report questionnaire developed to assess a variety of dysfunctional beliefs thought to underlie OCD symptoms. Three factor analytically derived subscales correspond to the following domains of obsessive beliefs: (a) overestimates of threat and responsibility for harm, (b) importance and control of intrusive thoughts, and (c) perfectionism and the need for certainty. Participants rate their agreement with each of 44 statements from 1 (disagree very much) to 7 (agree very much). The instrument possesses good validity and internal consistency, and has been widely studied in clinical and nonclinical samples. Cronbach alphas for the subscales ranged from .89 to .91. | Follow-up (6 months after the end of treatment) | |
Secondary | Session-level Change in Patient EX/RP Adherence Scale - Therapist Rated at each session beginning with session 4 | The PEAS is a 3-item questionnaire that assesses patient adherence to between-session exposures and response prevention in exposure and response prevention (ERP) therapy. This form is rated by the therapist. | Sessions 4-16 (twice per week for 6 weeks following week 2 of treatment) | |
Secondary | Treatment Credibility and Expectancy Questionnaire | The Treatment Credibility and Expectancy Questionnaire is a 6-item questionnaire that assesses patient beliefs about the credibility and useful of the treatment they received, on a 10-point scale. | Session 4 (2 weeks following Baseline) | |
Secondary | Change from Baseline Dimensional Obsessive Compulsive Scale (DOCS) at 8 weeks | The DOCS is a 20-item self-report measure that assesses the severity of the four most consistently replicated OCD symptom dimensions, which correspond to the measure's four empirically derived subscales: (a) contamination, (b) responsibility for harm and mistakes, (c) symmetry/ordering, and (d) unacceptable thoughts. Five items (rated 0 to 4) assess the following parameters of severity of each dimension: (a) time occupied by obsessions and rituals, (b) avoidance, (c) distress, (d) functional interference, and (e) difficulty disregarding the obsessions and refraining from rituals. Scores on these subscales converge well with other measures of OCD symptom dimensions. The internal consistency of the pre-treatment DOCS subscales in the present sample ranged from ( = .93-.96; total scale = .84). | Posttreatment (8 weeks after Baseline) | |
Secondary | Change from Posttreatment Dimensional Obsessive Compulsive Scale (DOCS) at 6 months | The DOCS is a 20-item self-report measure that assesses the severity of the four most consistently replicated OCD symptom dimensions, which correspond to the measure's four empirically derived subscales: (a) contamination, (b) responsibility for harm and mistakes, (c) symmetry/ordering, and (d) unacceptable thoughts. Five items (rated 0 to 4) assess the following parameters of severity of each dimension: (a) time occupied by obsessions and rituals, (b) avoidance, (c) distress, (d) functional interference, and (e) difficulty disregarding the obsessions and refraining from rituals. Scores on these subscales converge well with other measures of OCD symptom dimensions. The internal consistency of the pre-treatment DOCS subscales in the present sample ranged from ( = .93-.96; total scale = .84). | Follow-up (6 months after the end of treatment) | |
Secondary | Session-level Change in Dimensional Obsessive Compulsive Scale at each session | The DOCS is a 20-item self-report measure that assesses the severity of the four most consistently replicated OCD symptom dimensions, which correspond to the measure's four empirically derived subscales: (a) contamination, (b) responsibility for harm and mistakes, (c) symmetry/ordering, and (d) unacceptable thoughts. Five items (rated 0 to 4) assess the following parameters of severity of each dimension: (a) time occupied by obsessions and rituals, (b) avoidance, (c) distress, (d) functional interference, and (e) difficulty disregarding the obsessions and refraining from rituals. Scores on these subscales converge well with other measures of OCD symptom dimensions. The internal consistency of the pre-treatment DOCS subscales in the present sample ranged from ( = .93-.96; total scale = .84). | Sessions 1-16 (twice per week for 8 weeks following Baseline) |
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