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Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343106
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
International OCD Foundation
Information provided by (Responsible Party):
Michael Twohig, Ph.D., Utah State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: ACT plus ERP Behavioral: ERP alone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Acceptance and Commitment Therapy With Exposure and Response Prevention to Enhance Treatment Engagement in Obsessive-Compulsive Disorder
Actual Study Start Date : July 12, 2011
Actual Primary Completion Date : January 9, 2017
Actual Study Completion Date : January 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACT plus ERP
Sessions 1 and 2 involved information-gathering, discussion of the ACT model of OCD and ERP, and introduction to self-monitoring of rituals. Session 3 involved the development of an exposure hierarchy and response prevention plan, and further explanation of the ACT-based approach to ERP which focuses on learning flexible responding in the presence of obsessions, anxiety, and urges to ritualize. Exposure practices (sessions 4-16) were procedurally similar to the ERP condition, but focused on the facilitation of ACT processes rather than on fear extinction. Homework exposure practice was linked to the participant's goals and values. Session 16 included an ACT model of relapse prevention focusing on following one's values in the presence of obsessive thoughts and compulsive urges.
Behavioral: ACT plus ERP
16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Acceptance and Commitment Therapy plus Exposure and Response Prevention (ACT plus ERP).

Experimental: ERP alone
ERP followed Kozak and Foa's treatment manual. Sessions 1 and 2 included information-gathering, psychoeducation about the cognitive-behavioral model of OCD and rationale for ERP, and introduction to self-monitoring of rituals. Session 3 was dedicated to developing the treatment plan (exposure hierarchy, response prevention plan). Sessions 4-16 included in-session prolonged and repeated gradual exposure therapy (in vivo and imaginal as needed), the assignment of daily exposure practices for between-sessions, and instructions to refrain from rituals (response prevention in session and between sessions), along with self monitoring of any rituals that were performed. Session 16 also addressed discontinuation and relapse prevention.
Behavioral: ERP alone
16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Exposure and Response Prevention (ERP alone) monotherapy.




Primary Outcome Measures :
  1. Change from Baseline Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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.

  2. Change from Posttreatment Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline Beck Depression Inventory II (BDI-II) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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.

  2. Change from Posttreatment Beck Depression Inventory II (BDI-II) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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.

  3. Change from Baseline Acceptance and Action Questionnaire - II (AAQ-II) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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.

  4. Change from Posttreatment Acceptance and Action Questionnaire - II (AAQ-II) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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.

  5. Session-level Change in Acceptance and Action Questionnaire - II (AAQ-II) at each session [ Time Frame: Sessions 1-16 (Twice per week for 8 weeks following Baseline) ]
    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.

  6. Change from Baseline Distress Tolerance Scale (DTS) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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 (α=.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.

  7. Change from Posttreatment Distress Tolerance Scale (DTS) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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 (α=.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.

  8. Change from Baseline Interpretation of Intrusions Inventory (III) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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.

  9. Change from Posttreatment Interpretation of Intrusions Inventory (III) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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.

  10. Session-level Change in Interpretation of Intrusions Inventory (III) at each session [ Time Frame: Sessions 1-16 (twice per week for 8 weeks following Baseline) ]
    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.

  11. Change from Baseline Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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.

  12. Change from Posttreatment Believability of Anxious Feelings and Thoughts Questionnaire (BAFT) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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.

  13. Change from Baseline Obsessive Beliefs Questionnaire (OBQ) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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.

  14. Change from Posttreatment Obsessive Beliefs Questionnaire (OBQ) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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.

  15. Session-level Change in Patient EX/RP Adherence Scale - Therapist Rated at each session beginning with session 4 [ Time Frame: Sessions 4-16 (twice per week for 6 weeks following week 2 of treatment) ]
    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.

  16. Treatment Credibility and Expectancy Questionnaire [ Time Frame: Session 4 (2 weeks following Baseline) ]
    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.

  17. Change from Baseline Dimensional Obsessive Compulsive Scale (DOCS) at 8 weeks [ Time Frame: Posttreatment (8 weeks after Baseline) ]
    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).

  18. Change from Posttreatment Dimensional Obsessive Compulsive Scale (DOCS) at 6 months [ Time Frame: Follow-up (6 months after the end of treatment) ]
    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).

  19. Session-level Change in Dimensional Obsessive Compulsive Scale at each session [ Time Frame: Sessions 1-16 (twice per week for 8 weeks following Baseline) ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343106


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Utah
Utah State University
Logan, Utah, United States, 84322
Sponsors and Collaborators
Utah State University
University of North Carolina, Chapel Hill
International OCD Foundation
Investigators
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Principal Investigator: Michael P Twohig, Ph.D. Utah State University
Principal Investigator: Jonathan Abramowitz, Ph.D. University of North Carolina, Chapel Hill
Publications:
Beck, A. T. (1996). Beck Depression Inventory (2nd ed.). San Antonio, TX: The Psychological Corporation.
Eifert, G. H., & Forsyth, J. P. (2005). Acceptance and commitment therapy for anxiety disorders: A practitioner's treatment guide to using mindfulness, acceptance, and values-based behavior change strategies. Oakland, CA US: New Harbinger Publications.
Franklin, M. E. (2005). Combining serotonin medication with cognitive-behavior therapy: Is it necessary for all OCD patients. In J. Abramowitz & A. Houts (eds.). Concepts and controversies in obsessive-compulsive disorder (pp. 377-389). New York: Springer.
Hayes, S. C. (2008). Climbing our hills: A beginning conversation on the comparison of acceptance and commitment therapy and traditional cognitive behavioral therapy. Clinical Psychology: Science and Practice, 15, 286-295.
Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. New York, NY US: Guilford Press.
Kelley, M. L., Heffer, R. W., Gresham, F. M., & Elliott, S. N. (1989). Development of a modified Treatment Evaluation Inventory. Journal of Psychopathology and Behavioral Assessment, 11, 235-247.
Levitt, J. T., Brown, T. A., Orsillo, S. M., & Barlow, D. H. (2004). The effects of acceptance versus suppression of emotion on subjective and psychophysiological response to carbon dioxide challenge in patients with panic disorder. Behavior Therapy, 35, 747-766.
Vogel, P. A., Stiles, T. C., & Gotestam, K. G. (2004). Adding cognitive therapy elements to exposure therapy for obsessive-compulsive disorder: a controlled study. Behavioural and Cognitive Psychotherapy, 32, 275-290.
Woods, C. M., Chambless, D. L., & Steketee, G. (2002). Homework compliance and behavior therapy outcome for panic with agoraphobia and obsessive compulsive disorder. Cognitive Behaviour Therapy, 31, 88-95.

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Responsible Party: Michael Twohig, Ph.D., Professor, Utah State University
ClinicalTrials.gov Identifier: NCT03343106    
Other Study ID Numbers: 2965
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data is available now.
Access Criteria: Data access requests should be directed to the one of the Principal Investigators via email. Requestors will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Twohig, Ph.D., Utah State University:
Acceptance and Commitment Therapy
Exposure and Response Prevention
Psychotherapy
Obsessive-Compulsive Disorder
Treatment Acceptability
Treatment Adherence
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders