Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study

Study Overview
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Brief Summary
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The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.

Official Title
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A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Psychotherapy
* Drug: Sildenafil Citrate 50Mg Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men diagnosed with erectile dysfunction Must be in the age range of 18 to 39 years Must be in a stable heterosexual relationship Must not be suffering from any medical or psychiatric illness Exclusion Criteria: Men not meeting criteria of diagnosis of erectile dysfunction Men not in a heterosexual relationship Men of or above the age of 40 years Men diagnosed with any medical or psychiatric illness or obese men

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>The cognitive behavior psychotherapy was administered to participants in this treatment arm. | Behavioral: Cognitive Behavioral Psychotherapy<br>* The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.<br>* Other names: Cognitive Behavior Psychotherapy;|
| Active Comparator: Control Group<br>This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction. | Drug: Sildenafil Citrate 50Mg Tab<br>* The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.<br>* Other names: PDE5i;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Functioning-5 | The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning. | 3 months maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, Anxiety, and Stress Scale-21 | The scale has three sub-scales. Depression sub scale, Minimum Score: Zero; Maximum Score: 42 Anxiety sub scale, Minimum Score: Zero; Maximum Score: 42 Stress sub scale, Minimum Score: Zero; Maximum Score: 42 The lowest scores on each of the sub scales indicate better functioning, the higher scores on each sub scale indicate a worse outcome. | 3 months maximum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Dysfunctions, Men Health