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

NCT03343106 | Completed

• 1 other identifier: 2965
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Acceptance and Commitment Therapy; Exposure and Response Prevention; Psychotherapy; Obsessive-Compulsive Disorder; Treatment Acceptability; Treatment Adherence

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (19)

• Change from Baseline Beck Depression Inventory II (BDI-II) at 8 weeks

  Posttreatment (8 weeks after Baseline)

• Change from Posttreatment Beck Depression Inventory II (BDI-II) at 6 months

  Follow-up (6 months after the end of treatment)

• Change from Baseline Acceptance and Action Questionnaire - II (AAQ-II) at 8 weeks

  Posttreatment (8 weeks after Baseline)

• Change from Posttreatment Acceptance and Action Questionnaire - II (AAQ-II) at 6 months

  Follow-up (6 months after the end of treatment)

• Session-level Change in Acceptance and Action Questionnaire - II (AAQ-II) at each session

  Sessions 1-16 (Twice per week for 8 weeks following Baseline)

Study Arms (2)

ACT plus ERP

EXPERIMENTAL

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

ERP alone

EXPERIMENTAL

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

Interventions

ACT plus ERP BEHAVIORAL

16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Acceptance and Commitment Therapy plus Exposure and Response Prevention (ACT plus ERP).

ACT plus ERP

ERP alone BEHAVIORAL

16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Exposure and Response Prevention (ERP alone) monotherapy.

ERP alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current severe depression or suicidal ideation
• Current substance abuse or dependence
• Current mania, psychosis, or borderline or schizotypal personality disorder

Sponsors & Collaborators

• Utah State University: lead
• University of North Carolina, Chapel Hill: collaborator
• International OCD Foundation: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (27)

• Abramowitz JS, Deacon BJ, Olatunji BO, Wheaton MG, Berman NC, Losardo D, Timpano KR, McGrath PB, Riemann BC, Adams T, Bjorgvinsson T, Storch EA, Hale LR. Assessment of obsessive-compulsive symptom dimensions: development and evaluation of the Dimensional Obsessive-Compulsive Scale. Psychol Assess. 2010 Mar;22(1):180-98. doi: 10.1037/a0018260.

  PMID: 20230164 BACKGROUND

• Abramowitz JS, Foa EB, Franklin ME. Exposure and ritual prevention for obsessive-compulsive disorder: effects of intensive versus twice-weekly sessions. J Consult Clin Psychol. 2003 Apr;71(2):394-8. doi: 10.1037/0022-006x.71.2.394.

  PMID: 12699033 BACKGROUND

• Abramowitz JS, Franklin ME, Zoellner LA, DiBernardo CL. Treatment compliance and outcome in obsessive-compulsive disorder. Behav Modif. 2002 Sep;26(4):447-63. doi: 10.1177/0145445502026004001.

  PMID: 12205821 BACKGROUND

• Abramowitz JS, Taylor S, McKay D. Potentials and limitations of cognitive treatments for obsessive-compulsive disorder. Cogn Behav Ther. 2005;34(3):140-7. doi: 10.1080/16506070510041202.

  PMID: 16195053 BACKGROUND

• Abramowitz JS, Taylor S, McKay D. Obsessive-compulsive disorder. Lancet. 2009 Aug 8;374(9688):491-9. doi: 10.1016/S0140-6736(09)60240-3.

  PMID: 19665647 BACKGROUND

• Beck, A. T. (1996). Beck Depression Inventory (2nd ed.). San Antonio, TX: The Psychological Corporation.

  BACKGROUND

• 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.

  BACKGROUND

• Foa EB, Kozak MJ, Goodman WK, Hollander E, Jenike MA, Rasmussen SA. DSM-IV field trial: obsessive-compulsive disorder. Am J Psychiatry. 1995 Jan;152(1):90-6. doi: 10.1176/ajp.152.1.90.

  PMID: 7802127 BACKGROUND

• Foa EB, Liebowitz MR, Kozak MJ, Davies S, Campeas R, Franklin ME, Huppert JD, Kjernisted K, Rowan V, Schmidt AB, Simpson HB, Tu X. Randomized, placebo-controlled trial of exposure and ritual prevention, clomipramine, and their combination in the treatment of obsessive-compulsive disorder. Am J Psychiatry. 2005 Jan;162(1):151-61. doi: 10.1176/appi.ajp.162.1.151.

  PMID: 15625214 BACKGROUND

• 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.

  BACKGROUND

• Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.

  PMID: 2684084 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

  PMID: 2002127 BACKGROUND

• 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.

  BACKGROUND

• Leung AW, Heimberg RG. Homework compliance, perceptions of control, and outcome of cognitive-behavioral treatment of social phobia. Behav Res Ther. 1996 May-Jun;34(5-6):423-32. doi: 10.1016/0005-7967(96)00014-9.

  PMID: 8687364 BACKGROUND

• 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.

  BACKGROUND

• Marcks BA, Woods DW. A comparison of thought suppression to an acceptance-based technique in the management of personal intrusive thoughts: a controlled evaluation. Behav Res Ther. 2005 Apr;43(4):433-45. doi: 10.1016/j.brat.2004.03.005.

  PMID: 15701355 BACKGROUND

• Marcks BA, Woods DW. Role of thought-related beliefs and coping strategies in the escalation of intrusive thoughts: an analog to obsessive-compulsive disorder. Behav Res Ther. 2007 Nov;45(11):2640-51. doi: 10.1016/j.brat.2007.06.012. Epub 2007 Jul 5.

  PMID: 17673167 BACKGROUND

• Masedo AI, Rosa Esteve M. Effects of suppression, acceptance and spontaneous coping on pain tolerance, pain intensity and distress. Behav Res Ther. 2007 Feb;45(2):199-209. doi: 10.1016/j.brat.2006.02.006. Epub 2006 Mar 29.

  PMID: 16569396 BACKGROUND

• Paez-Blarrina M, Luciano C, Gutierrez-Martinez O, Valdivia S, Ortega J, Rodriguez-Valverde M. The role of values with personal examples in altering the functions of pain: comparison between acceptance-based and cognitive-control-based protocols. Behav Res Ther. 2008 Jan;46(1):84-97. doi: 10.1016/j.brat.2007.10.008. Epub 2007 Oct 22.

  PMID: 18054894 BACKGROUND

• Simpson HB, Zuckoff AM, Maher MJ, Page JR, Franklin ME, Foa EB, Schmidt AB, Wang Y. Challenges using motivational interviewing as an adjunct to exposure therapy for obsessive-compulsive disorder. Behav Res Ther. 2010 Oct;48(10):941-8. doi: 10.1016/j.brat.2010.05.026. Epub 2010 Jun 1.

  PMID: 20609435 BACKGROUND

• Steketee G, Chambless DL, Tran GQ, Worden H, Gillis MM. Behavioral avoidance test for obsessive compulsive disorder. Behav Res Ther. 1996 Jan;34(1):73-83. doi: 10.1016/0005-7967(95)00040-5.

  PMID: 8561767 BACKGROUND

• Twohig MP, Hayes SC, Masuda A. Increasing willingness to experience obsessions: acceptance and commitment therapy as a treatment for obsessive-compulsive disorder. Behav Ther. 2006 Mar;37(1):3-13. doi: 10.1016/j.beth.2005.02.001. Epub 2006 Feb 21.

  PMID: 16942956 BACKGROUND

• Twohig MP, Hayes SC, Plumb JC, Pruitt LD, Collins AB, Hazlett-Stevens H, Woidneck MR. A randomized clinical trial of acceptance and commitment therapy versus progressive relaxation training for obsessive-compulsive disorder. J Consult Clin Psychol. 2010 Oct;78(5):705-16. doi: 10.1037/a0020508.

  PMID: 20873905 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Michael P Twohig, Ph.D.

  Utah State University

  PRINCIPAL INVESTIGATOR

• Jonathan Abramowitz, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: July 12, 2011
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (2)