Obsessive-Compulsive DisorderNCT02314195
Music Therapy in Obsessive Compulsive Disorder
A study testing Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy and Music therapy in people with Obsessive-Compulsive Disorder and Anxiety, run by Islamic Azad University, Marvdasht at 1 site in Iran.
Trial summary
Previous studies have highlighted the potential therapeutic benefits of receptive individual music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder, Anxiety, Depression
- What is being tested?
- Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy and Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Apr 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were at least 18 years or older;
- had axis I diagnosis of OCD according to the criteria delineated by the diagnostic and statistical manual of mental disorders - fourth edition diagnosed by an experienced psychiatrist
- had not received treatment previously for the disorder
- agreed to partake in the study
Who cannot join
- refused to partake in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Music Therapy as an Adjunct to Standard Treatment for Obsessive Compulsive Disorder and Co-morbid Anxiety and Depression in Iran
Previous studies have highlighted the potential therapeutic benefits of receptive individual music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive compulsive disorder have not been investigated to date. The present study therefore aimed to investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion of patients with OCD have other comorbid mood or anxiety disorders, the question of whether therapeutic benefits of music could be expanded to also affect concurrent depressive and anxiety symptoms was explored.
- Conditions
- Obsessive-Compulsive Disorder, Anxiety, Depression
- Being tested
- Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy, Music therapy
- Keywords
- Obsessive Compulsive Disorder, Music Therapy/methods, Combined Modality Therapy, Anxiety Disorders/therapy
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective serotonin re-uptake inhibitorDrug
Also called Pharmacotherapy
A medication of selective serotonin re-uptake inhibitor (SSRI) family, Behavioral. The type and dosage of the medication was decided by the treating psychiatrist.
Cognitive Behavioral TherapyBehavioural
Also called Psychotherapy
Cognitive Behavioral Therapy for obsessive compulsive disorder carried out by a psychologist.
Music therapyOther
Also called Receptive music therapy
12 sessions of 30-minute individual-based receptive music therapy, supervised by the treating psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + music therapy | Active comparator | Selective serotonin re-uptake inhibitor plus cognitive behavioral therapy. Music therapy encompassing 12 half-hour sessions of therapist-supervised receptive music therapy scheduled over four weeks Receives: Drug: Selective serotonin re-uptake inhibitor; Behavioral: Cognitive Behavioral Therapy; Other: Music therapy |
| Standard treatment only | Active comparator | Selective serotonin re-uptake inhibitor plus cognitive behavioral therapy. Receives: Drug: Selective serotonin re-uptake inhibitor; Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsession (Maudsley Obsessive-Compulsive Inventory)
Post-intervention scores on Maudsley Obsessive-Compulsive Inventory
Measured: 1 month
Secondary outcomes (3)
Obsession subtype (Maudsley Obsessive-Compulsive Inventory sub-types)
Post-intervention scores on Maudsley Obsessive-Compulsive Inventory sub-types
Measured: 1 month
Anxiety symptoms (Beck Anxiety Inventory)
Post-intervention scores on Beck Anxiety Inventory
Measured: 1 month
Depressive symptoms (Beck Depression Inventory - Short Form)
Post-intervention scores on Beck Depression Inventory - Short Form
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Marvdasht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahrzad Shirani, Islamic Azad University, Marvdasht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314195
- Sponsor's protocol ID
- 2172719
- Status last verified
- Dec 2014
- First submitted
- 27 Nov 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Music Therapy as an Adjunct to Standard Treatment for Obsessive Compulsive Disorder and Co-morbid Anxiety and Depression in Iran
- ClinicalTrials.gov ID
- NCT02314195
- Acronym / sponsor ID
- 2172719
- Conditions
- Obsessive-Compulsive Disorder, Anxiety, Depression
- Keywords
- Obsessive Compulsive Disorder, Music Therapy/methods, Combined Modality Therapy, Anxiety Disorders/therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Islamic Azad University, MarvdashtUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have highlighted the potential therapeutic benefits of receptive individual music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive compulsive disorder have not been investigated to date. The present study therefore aimed to investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion of patients with OCD have other comorbid mood or anxiety disorders, the question of whether therapeutic benefits of music could be expanded to also affect concurrent depressive and anxiety symptoms was explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + music therapy | Active comparator | Drug: Selective serotonin re-uptake inhibitor, Behavioral: Cognitive Behavioral Therapy, Other: Music therapySelective serotonin re-uptake inhibitor plus cognitive behavioral therapy. Music therapy encompassing 12 half-hour sessions of therapist-supervised receptive music therapy scheduled over four weeks |
| Standard treatment only | Active comparator | Drug: Selective serotonin re-uptake inhibitor, Behavioral: Cognitive Behavioral TherapySelective serotonin re-uptake inhibitor plus cognitive behavioral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- were at least 18 years or older;
- had axis I diagnosis of OCD according to the criteria delineated by the diagnostic and statistical manual of mental disorders - fourth edition diagnosed by an experienced psychiatrist
- had not received treatment previously for the disorder
- agreed to partake in the study
Key exclusion criteria (1 listed)
- refused to partake in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective serotonin re-uptake inhibitorAlso: PharmacotherapyA medication of selective serotonin re-uptake inhibitor (SSRI) family, Behavioral. The type and dosage of the medication was decided by the treating psychiatrist. | Drug | Standard treatment + music therapy, Standard treatment only |
| Cognitive Behavioral TherapyAlso: PsychotherapyCognitive Behavioral Therapy for obsessive compulsive disorder carried out by a psychologist. | Behavioural | Standard treatment + music therapy, Standard treatment only |
| Music therapyAlso: Receptive music therapy12 sessions of 30-minute individual-based receptive music therapy, supervised by the treating psychiatrist. | Other | Standard treatment + music therapy |
Primary outcome
Obsession (Maudsley Obsessive-Compulsive Inventory)
Time frame: 1 month
Post-intervention scores on Maudsley Obsessive-Compulsive Inventory
3 secondary outcomes
Obsession subtype (Maudsley Obsessive-Compulsive Inventory sub-types)
Time frame: 1 month
Anxiety symptoms (Beck Anxiety Inventory)
Time frame: 1 month
Depressive symptoms (Beck Depression Inventory - Short Form)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy and Music therapy in people with Obsessive-Compulsive Disorder and Anxiety, run by Islamic Azad University, Marvdasht at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsession (Maudsley Obsessive-Compulsive Inventory) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.