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Protocol Development and Empirical Validation of Positive Psychotherapy Based on Belief to Good in Individuals with Signs and Symptoms of Depression: A single Case Multiple Baseline Study.

Protocol summary

Summary
The aim of study is to develop and validate a Positive Psychotherapy based on Belief to Good in decreasing Depression. According this, the Single Subject Multiple Baseline Study will be conducted. The first, three patients with Signs and Symptoms of Depression that have Inclusion and Eexclusion criteria will choose from a Center of Counseling and Psychological Services in Tehran by Purposeful Sampling. An Inclusion criterion is: score 14-35 in Beck Depression Inventory-II. An Exclusion criterion is: Having symptoms of psychotic disorders. Each 3 participants are entered the Base line phase (from 3 to 7 week) at the same time. Then, Participants are randomly assigned in to treatment. Treatment is conducted by the Investigator in 8 sessions. Basic Acceptance, Freedom from judgment, Belief to Good in difficulty, Life Values, Identification Virtues and Strengths, Savoring, Gratitude, Active and Constructive Responding will run in sessions. Within Base line stage (3-7 weeks) Therapy phase (8 week) and Follow up steps (1 and 3 month after treatment), patients fill out Beck Depression Inventory (BDI-II), Hamilton Rating Scale for Depression-17, Orientations of Happiness, Positive And Negative Affect Scale (PANAS), Meaning in Life(MLQ), Riff’s Psychological Well-being Inventory, The Oxford Happiness Questionnaire and Satisfaction With Life Scale (SWLS). All of the assessment, in Baseline, Treatment process and Follow up is done by an MA in Psychology.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070818405N1
Registration date: 2015-01-14, 1393/10/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-14, 1393/10/24
Registrant information
Name
Azam Noferesty
Name of organization / entity
Shahed univercity
Country
Iran (Islamic Republic of)
Phone
+98 88302524
Email address
noferest88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Protocol Development and Empirical Validation of Positive Psychotherapy Based on Belief to Good in Individuals with Signs and Symptoms of Depression: A single Case Multiple Baseline Study.
Public title
Treatment of Signs and Symptoms of Depression with Positive Psychotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: score 14-35 in Beck Depression Inventory-II; minimum age 25; agreed to participate in the study; signed consent form. Exclusion criteria: Having symptoms of psychotic disorders and severe personality disorder; having symptoms of drug abuse; a suicide plan; having severe depressive symptoms (BDI score is higher than 36).
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 3
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study is a Single Subject Multiple Baseline. So, each Participants act as own control.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahed Univercity
Street address
Shahed Univercity, top Tehran-Qom highway, Iran, Tehran.
City
Tehran
Postal code
3319118651
Approval date
2014-06-05, 1393/03/15
Ethics committee reference number
1393-03-15

Health conditions studied

1

Description of health condition studied
Sign and Symptom of Depression
ICD-10 code
F32.0, F32
ICD-10 code description
F32.0 Mild depressive episode: Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities. F32.1 Moderate depressive episode: Four or more of the above symp

Primary outcomes

1

Description
Depression
Timepoint
Base line phase, Treatment sessions, Post treatment and Follow up
Method of measurement
BDI-II, Hamilton Rating Scale for Depression-17

Secondary outcomes

1

Description
Psychological Well-being
Timepoint
Base line phase, Post treatment and Follow up
Method of measurement
Psychological Well-being Test

2

Description
Happiness
Timepoint
Base line phase, Treatment sessions, Post Treatment and Follow up
Method of measurement
The Oxford Happiness Questionnaire

3

Description
Satisfaction With Life
Timepoint
Base line phase, Post treatment and Follow up
Method of measurement
Satisfaction With Life Scale

4

Description
Positive And Negative Affect
Timepoint
Base line phase, Treatment sessions, Post Treatment and Follow up
Method of measurement
Positive And Negative Affect Scale

Intervention groups

1

Description
Positive Psychotherapy Based on Belief to Good: 8 Positive Interventions was applied in 8 sessions (45 minutes) weekly.These techniques include: Basic Acceptance, Freedom from Judgment, Belief to Good in difficulty, Life Values, Identification Virtues and Strengths, Savoring, Gratitude, Active and Constructive Responding.
Category
Other

2

Description
without control Group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ostad Roozbeh
Full name of responsible person
Azam Noferesty
Street address
43, Talleghani Squre, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Azam Noferesty
Street address
N28, Joharchi Avenue, Shariati Streat, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Azam Noferesty
Position
Phd Student in Clinical Psychology
Other areas of specialty/work
Street address
N28, Joharchi Avenue, Shariati Street, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 7762 4451
Fax
Email
noferest88@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Azam Noferesty
Position
Phd Student in Clinical Psychology
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 7762 4451
Fax
Email
noferest88@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed Univercity
Full name of responsible person
Azam Noferesty
Position
Investigator
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 7762 4451
Fax
Email
noferest88@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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