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

November 26, 2019 updated by: Ahmad Bilal, International Islamic University, Islamabad

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • South Punjab
      • Bahāwalpur, South Punjab, Pakistan, 63100
        • Ahmad Bilal Private Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Functioning-5
Time Frame: 3 months maximum
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
Time Frame: 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.
3 months maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Islamic University, Islamabad

Investigators

  • Principal Investigator: Ahmad Bilal, MPhil, International Islamic University, Islamabad, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

July 24, 2018

Study Completion (Actual)

July 24, 2018

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0925-0585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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