Depression ModerateCBTBGCNCT04192721
Cognitive Behavioral Therapy-Based Group Counseling
A study testing Cognitive Behavioral Therapy-Based Group Counseling in people with Depression Moderate and Depression Mild, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Depression Moderate, Depression Mild
- What is being tested?
- Cognitive Behavioral Therapy-Based Group Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 23 Feb 2018
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having mild depressive symptoms according to the BDI
- Having moderate depressive symptoms according to the BDI
- Being native speakers of Turkish
- Agreeing to participate in the entire intervention process
Who cannot join
- Having substance abuse
- Having another psychiatric diagnosis
- Using psychotropic drugs
- Receiving other counseling or therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms
The university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.
Read the detailed description
This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.
The study was completed with a total of 63 participants (n=31 for the intervention group and n=32 for the control group) in the 2017-2018 academic year. The effect of the intervention was evaluated with the Beck Depression Inventory, Beck Anxiety Inventory, Automatic Thoughts Questionnaire, and Ways of Coping Questionnaire. The measurements were taken 3 times: pre-test, post-test, and 2-months post-test.
- Conditions
- Depression Moderate, Depression Mild
- Being tested
- Cognitive Behavioral Therapy-Based Group Counseling
- Keywords
- depression, cognitive behavioral therapy, group counseling, nursing students
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy-Based Group CounselingBehavioural
- Relaxation techniques
- Providing personal development books
- Sharing the factors affecting the situation defined as depression (brainstorming)
- Explaining the link between depressive symptoms, thoughts, feelings, and behaviors
- Explaining automatic thoughts
- Application of relaxation techniques; deep-breathing exercises
- Identifying alternative thoughts
- Explaining the correlation between alternative thoughts and mood
- Introduction of the Automatic-Thought Registration Form and distribution to students
- Describing the effects of depression on social interaction
- Explaining activities that could be done individually and with the group
- Distribution of the activity list to students
- Description of ways of coping with stress
- Determination of individual stressors and their effects
- Planning for the future: preventing depression
- Discussion of assumptions/expectations about life
- Homeworks related to session contents
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy-Based Group Counseling | Experimental | The CBT-based group counseling provided to the intervention group was carried out as a group intervention with structured sessions in which various techniques and methods of CBT, having mainly educational content, were applied, including an experiential interaction process. The counseling was performed in a total of six 60- to 90-minute sessions, comprising one session per week for four groups consisting of six to 10 members each. Receives: Behavioral: Cognitive Behavioral Therapy-Based Group Counseling |
| Control group | No intervention | No counseling was given to the control group during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI)
It measures the risk level of depression. It has 21 items. Each item is scored 0-3 points and the total score ranges from 0-63 (0-9=no; 10-16= mild; 17-20= moderate; 21-26=high; 27 or more points severe depressive symptoms)
Measured: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Beck Anxiety Inventory (BAI)
This self-assessment scale determines anxiety level. It consists of 21 items. Each item is scored 0-3 points and the total score ranges from 0-63. As the total score increases, the anxiety level increases.
Measured: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Automatic Thoughts Questionnaire (ATQ)
It measures the thought patterns and negative self-assessments commonly seen in depression. It consists of 30 items. Each item is scored 1-5 points and the total score ranges from 30-150 points. A high score indicates that the frequency of automatic thoughts related to depression is high.
Measured: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Ways of Coping Questionnaire (WCQ)
It measures the thought patterns and negative self-assessments commonly seen in depression. It consists of 30 items. Each item is scored 1-5 points and the total score ranges from 30-150 points. A high score indicates that the frequency of automatic thoughts related to depression is high.
Measured: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Nov 2017
- Primary completion29 Dec 2017
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression ModerateStudies 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
- Model description
- The study used a randomized control clinical trial design. In the BDI pre-test, 80 of the students with mild or moderate depressive symptoms met the other inclusion criteria of the study and volunteered to participate in the study. Out of 80 participants, 40 were randomly assigned to the intervention group and 40 to the control group using computer-generated random number sequences. The study was completed with a total of 63 participants (n=31 for the intervention group; n=32 for the control group). While CBT-based group counseling was given to the intervention group, no counseling was given to the control group during the study. The participants were evaluated at three time points: at screening (pre-test), six weeks after screening (post-intervention/post-test), and two months after the post-test. The measurements were taken simultaneously in the intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satı Demir, Gazi University
- Investigators
- Satı Demir, PhD, Principal investigator, Gazi University Health Sciences Faculty, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192721
- Sponsor's protocol ID
- SDemir
- Acronym
- CBTBGC
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04192721
- Acronym / sponsor ID
- CBTBGC / SDemir
- Conditions
- Depression Moderate, Depression Mild
- Keywords
- depression, cognitive behavioral therapy, group counseling, nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 10 Dec 2019 (actual)
- 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.
The university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.
Detailed description
This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.
The study was completed with a total of 63 participants (n=31 for the intervention group and n=32 for the control group) in the 2017-2018 academic year. The effect of the intervention was evaluated with the Beck Depression Inventory, Beck Anxiety Inventory, Automatic Thoughts Questionnaire, and Ways of Coping Questionnaire. The measurements were taken 3 times: pre-test, post-test, and 2-months post-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study used a randomized control clinical trial design. In the BDI pre-test, 80 of the students with mild or moderate depressive symptoms met the other inclusion criteria of the study and volunteered to participate in the study. Out of 80 participants, 40 were randomly assigned to the intervention group and 40 to the control group using computer-generated random number sequences. The study was completed with a total of 63 participants (n=31 for the intervention group; n=32 for the control group). While CBT-based group counseling was given to the intervention group, no counseling was given to the control group during the study. The participants were evaluated at three time points: at screening (pre-test), six weeks after screening (post-intervention/post-test), and two months after the post-test. The measurements were taken simultaneously in the intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy-Based Group Counseling | Experimental | Behavioral: Cognitive Behavioral Therapy-Based Group CounselingThe CBT-based group counseling provided to the intervention group was carried out as a group intervention with structured sessions in which various techniques and methods of CBT, having mainly educational content, were applied, including an experiential interaction process. The counseling was performed in a total of six 60- to 90-minute sessions, comprising one session per week for four groups consisting of six to 10 members each. |
| Control group | No intervention | –No counseling was given to the control group during the study. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having mild depressive symptoms according to the BDI
- Having moderate depressive symptoms according to the BDI
- Being native speakers of Turkish
- Agreeing to participate in the entire intervention process
Key exclusion criteria (4 listed)
- Having substance abuse
- Having another psychiatric diagnosis
- Using psychotropic drugs
- Receiving other counseling or therapy
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 |
|---|---|---|
| Cognitive Behavioral Therapy-Based Group Counseling* Relaxation techniques * Providing personal development books * Sharing the factors affecting the situation defined as depression (brainstorming) * Explaining the link between depressive symptoms, thoughts, feelings, and behaviors * Explaining automatic thoughts * Application of relaxation techniques; deep-breathing exercises * Identifying alternative thoughts * Explaining the correlation between alternative thoughts and mood * Introduction of the Automatic-Thought Registration Form and distribution to students * Describing the effects of depression on social interaction * Explaining activities that could be done individually and with the group * Distribution of the activity list to students * Description of ways of coping with stress * Determination of individual stressors and their effects * Planning for the future: preventing depression * Discussion of assumptions/expectations about life * Homeworks related to session contents | Behavioural | Cognitive Behavioral Therapy-Based Group Counseling |
Primary outcome
Beck Depression Inventory (BDI)
Time frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
It measures the risk level of depression. It has 21 items. Each item is scored 0-3 points and the total score ranges from 0-63 (0-9=no; 10-16= mild; 17-20= moderate; 21-26=high; 27 or more points severe depressive symptoms)
Beck Anxiety Inventory (BAI)
Time frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
This self-assessment scale determines anxiety level. It consists of 21 items. Each item is scored 0-3 points and the total score ranges from 0-63. As the total score increases, the anxiety level increases.
Automatic Thoughts Questionnaire (ATQ)
Time frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
It measures the thought patterns and negative self-assessments commonly seen in depression. It consists of 30 items. Each item is scored 1-5 points and the total score ranges from 30-150 points. A high score indicates that the frequency of automatic thoughts related to depression is high.
Ways of Coping Questionnaire (WCQ)
Time frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
It measures the thought patterns and negative self-assessments commonly seen in depression. It consists of 30 items. Each item is scored 1-5 points and the total score ranges from 30-150 points. A high score indicates that the frequency of automatic thoughts related to depression is high.
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 10 Dec 2019.
- Individual participant dataSharing planned: No. Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.
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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.
Satı Demir, PhD principal investigator
Gazi University Health Sciences Faculty, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy-Based Group Counseling in people with Depression Moderate and Depression Mild, run by Gazi University at 1 site in Turkey (Türkiye).
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 4 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 10 Dec 2019. 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 Turkey (Türkiye). 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?
Beck Depression Inventory (BDI) (time frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)). The study lists 4 primary outcomes in all. 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 10 Dec 2019.