Evaluation of a Cognitive Therapy (Inference-based-therapy) for the Treatment of Obsessional Compulsive Disorder

NCT01794156 | Completed

• 1 other identifier: 119587
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Obsessional compulsive disorder (OCD) is a very debilitating psychiatric problem which affects around one million Canadians and their families. Obsessions are intense preoccupations about bad, harmful, dangerous, shocking or unlucky events which 'may' occur and which drive sufferers to perform time consuming and distressing compulsive rituals to prevent the possible event occurring. The current psychological treatment of choice is cognitive behavior (CBT) therapy which focuses on treating OCD by reducing obsessional anxiety about the likelihood and the consequences of the preoccupying event. A rival cognitive model termed the inference-based therapy (IBT), developed by the principal investigator and co-workers, considers that the OCD begins with the initial doubting inference 'maybe something is wrong' and focuses on changing the reasoning behind this doubting inference which often trumps the common sense conviction that there is no reason to doubt. This clinical trial randomly allocates participants to either IBT or CBT treatment condition or to a third generic mindfulness condition. The latter condition is a non-specific meditational-based training which has shown evidence of reducing stress and anxiety across a number of psychiatric problems including OCD. Two hundred and forty people will be recruited over a 5-year period from two principal sites (Montreal and Gatineau/Ottawa) with which the principal investigator and co-investigators have clinical links. Therapy will be administered by trained professionals following a treatment manual specific to each approach. The therapy will last a maximum of six months or until the point when the person achieves a non-clinical status. The patients will be assessed pre, post, and at six months following treatment on standard evaluation instruments as well as on subjective measures. We expect the IBT to be superior in terms of number of participants responding to treatment, rapidity of improvement and gains at follow-up.

Conditions

Obsessive Compulsive Disorder

Keywords

Inference-based therapy; Cognitive behavior therapy; Obsessive compulsive disorder; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  The Yale-Brown Obsessive-Compulsive Scale (translation) is the instrument of choice to assess obsessive compulsive symptoms and severity.

  Baseline, change after 26 weeks of treatment, change after 6-month follow-up

Secondary Outcomes (13)

• Vancouver Obsessional Compulsive Inventory (VOCI)

  Baseline, change after 26 weeks of treatment, change after 6-month follow-up

• Obsessive Beliefs Questionnaire (OBQ-44)

  Baseline, change after 26 weeks of treatment, change after 6-month follow-up

• Beck Depression Inventory (BDI)

  Baseline, change after 26 weeks of treatment, change after 6-month follow-up

• Beck Anxiety Inventory (BAI)

  Baseline, change after 26 weeks of treatment, change after 6-month follow-up

• Over-Values Ideas Scale (OVIS)

  Baseline, change after 26 weeks of treatment, change after 6-month follow-up

Other Outcomes (1)

• Clinical Interview

  pre-treatment, post-treatment and 6 month follow-up

Study Arms (3)

Cognitive behavior therapy

ACTIVE COMPARATOR

1. The cognitive-behavioral model is presented and individualized. 2. Cognitive correction: beliefs are addressed by explaining their roles in maintaining cognitive biases. Next, clients are trained to identify and to challenge their key beliefs 3. Exposure and response prevention (ERP) using imaginal and in vivo exposure and to both over and covert neutralization is implemented according to hierarchies developed following the individual assessment. Extended periods of exposure permits emotional discomfort to dissipate. 4. Combined phase: continues ERP while making explicit links to the cognitive targets. 5. Relapse prevention included a written individualized guide to encourage the maintenance of treatment gains. Self-directed ERP continues.

Behavioral: Cognitive behavior therapy

Mindfulness-based stress reduction (MBSR)

ACTIVE COMPARATOR

The entire intervention is based on systematic and intensive training in MBSR following Santorelli and Kabat-Zinn and their applications to everyday life. The program is divided in 8 consecutive blocks with daily homework in mindfulness-based stress reduction skills. The main activity of MBSR is a cognitive and intervention-based process characterized by self-regulation of attention to the present moment and an open and accepting orientation towards one's experience.

Behavioral: Mindfulness-based stress reduction

Inference-based therapy

EXPERIMENTAL

The inference-based therapy will be delivered in 10-step The client will: * learn that the compulsions, anxiety and discomfort are driven by an initial obsessional doubt * learn why this doubt is 100% irrelevant here and now * learn the inferential confusion process * have to recognize that the doubt originates from him/her * have to identify/describe the narrative leading him/her to the doubt * have to identify the cross-over point when he/she leaves reality * learn to be aware of the reasoning devices * learn how personal themes dictate the idiosyncratic nature of the person's obsession * explore and reinforced an alternative self-view * be trained to use properly his/her senses in the face of obsessional triggers situations

Behavioral: Inference-based therapy

Interventions

Cognitive behavior therapy BEHAVIORAL

Cognitive behavior therapy

Mindfulness-based stress reduction BEHAVIORAL

Mindfulness-based stress reduction (MBSR)

Inference-based therapy BEHAVIORAL

Inference-based therapy

Eligibility Criteria

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

You may qualify if:

• primary diagnosis according to DSM-IV-TR criteria of OCD
• willingness to keep medication stable while participating in study
• willingness to undergo active psychological treatment
• willingness to undergo randomization into treatment modality
• fluency in either English or French.
• entry criteria do not exclude a secondary diagnosis on Axis I or II providing it does not require treatment or is deemed unlikely to significantly affect compliance with the current treatment plan.
• participants will also be screened on a brief battery of neuropsychological tests to ensure comparability of mental capacity between groups.
• no change in medication type or dose during the 12 weeks before treatment for antidepressants (4 weeks for anxiolytics. If antidepressant or medication as not been stable for at least 12 weeks, a stabilization period will be imposed. Other medication (e.g., anxiolytics) will have to be stable for at least four weeks.

You may not qualify if:

• presence of other principal axes 1 disorders requiring treatment
• evidence of suicidal intent
• evidence of current substance abuse
• evidence of current or past of suicidal intent
• evidence of current or past schizophrenia, bipolar disorder or organic mental disorder

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre de recherche de l'Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness

Study Officials

• Frederick Aardema, Ph. D.

  Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph. D.

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 18, 2013
• Study Start: September 1, 2012
• Primary Completion: August 1, 2019
• Study Completion: August 30, 2019
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

CA (1)