Obsessive Compulsive Disorder Clinical Trial
Official title:
Evaluation of a Cognitive Therapy (Inference-based-therapy) for the Treatment of Obsessional Compulsive Disorder
NCT number | NCT01794156 |
Other study ID # | 119587 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | August 30, 2019 |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | August 30, 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche de l'Institut universitaire en santé mentale de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Interview | A clinical interview assesses content, form, and appraisal of obsessions as well as neutralization strategies used with the target obsession. | pre-treatment, post-treatment and 6 month follow-up | |
Primary | 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 | Vancouver Obsessional Compulsive Inventory (VOCI) | The Vancouver Obsessional Compulsive Inventory (VOCI)(Translation) to assess a broad spectrum of OCD symptoms and associated personality characteristics.It is a 55-item self-report measure to assess a broad spectrum of OCD symptoms and associated personality characteristics. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Obsessive Beliefs Questionnaire (OBQ-44) | The Obsessive Beliefs Questionnaire (OBQ-44) is a 44-item measure developed by the Obsessive Compulsive Cognitions Working Group between 1995 and 1998. The OBQ consist in three twinned domains based on the working group consensus (over-responsibility/over-estimation of threat, intolerance of uncertainty/over-importance of thought, control of thoughts/perfectionism). | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) (Translation) is a standard 21-item measure to assess depressive symptoms. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory (BAI)(Translation) is a standard 21-item anxiety symptom checklist rating anxiety symptom intensity for the last week on a 0-3 scale. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Over-Values Ideas Scale (OVIS) | Over-Valued Ideas Scale (OVIS)(Translation)is a 11-item clinician-rated scale measuring degree of conviction, insight, justification and actions following from belief. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Inferential Confusion Questionnaire (ICQ) | The ICQ was originally developed in French and is a 30-item questionnaire. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Semi-structured interview to assess primary inference process | Primary inference processes will be rated by semi-structured interview for each obsession on a clinical scale, and daily by the participant, in the daily diary. Strength is rated 0-100 in accordance with how probable the participant considers the primary belief whether it is a doubt "maybe the door isn't locked properly". | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Mindful Attention Awareness Scale (MAAS) | The MAAS is a 15-item questionnaire which measures the tendency to be attentive and aware of present moment experience in everyday life and does not require extensive experience with mindfulness. It is uni-dimensional and is appropriate for exploring changes in awareness and attention associated with mindfulness-based stress reduction (MBSR) and is predictive of mood and adaptive regulation. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Global Assessment of Functioning (GAF) scale (DSM-IV, Axis V) | The GAF is a standard DSM measure of adaptation and functioning scored from 0-100. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Systematic Quality of Life Inventory | The Systematic Quality of Life Inventory measure 30 life domains, using three subscales: actual state, goal state and the difference between actual and desired goals of quality of life. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Life Experience Survey | The Life Experience Survey measures negative and positive life events and their impact over 57 life domains. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Social Support Questionnaire | The Social Support Questionnaire has two scales measuring amount and degree of satisfaction with social support. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up | |
Secondary | Social Self-esteem Inventory | The Social Self-esteem Inventory measures agreement on 30 self-statements. | Baseline, change after 26 weeks of treatment, change after 6-month follow-up |
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