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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Sildenafil Citrate 50Mg Tab; Behavioral: Cognitive Behavioral Psychotherapy

• Registration Number: NCT04179747
• Lead Sponsor: International Islamic University, Islamabad

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Primary Completion: 2018-07-24
• Study Completion: 2018-07-24
• Status Verified: 2019-11
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

1. Men diagnosed with erectile dysfunction
2. Must be in the age range of 18 to 39 years
3. Must be in a stable heterosexual relationship
4. Must not be suffering from any medical or psychiatric illness

Exclusion Criteria

1. Men not meeting criteria of diagnosis of erectile dysfunction
2. Men not in a heterosexual relationship
3. Men of or above the age of 40 years
4. Men diagnosed with any medical or psychiatric illness or obese men

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control Group	Sildenafil Citrate 50Mg Tab	This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction.
Group A	Cognitive Behavioral Psychotherapy	The cognitive behavior psychotherapy was administered to participants in this treatment arm.

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Functioning-5	3 months maximum	The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.

Secondary Outcome Measures

Name	Time	Method
Depression, Anxiety, and Stress Scale-21	3 months maximum	The scale has three sub-scales.; 1. Depression sub scale, Minimum Score: Zero; Maximum Score: 42; 2. Anxiety sub scale, Minimum Score: Zero; Maximum Score: 42; 3. 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.

Trial Locations

Locations (1)

Ahmad Bilal Private Practice; 🇵🇰 Bahāwalpur, South Punjab, Pakistan