Clinical trial NCT04192721: Cognitive Behavioral Therapy-Based Group Counseling
Official title: Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Moderate
Depression Mild
Keywords: depression
cognitive behavioral therapy
group counseling
nursing students
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Having substance abuse
* Having another psychiatric diagnosis
* Using psychotropic drugs
* Receiving other counseling or therapy

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
measure: Automatic Thoughts Questionnaire (ATQ)
timeFrame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
measure: Ways of Coping Questionnaire (WCQ)
timeFrame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Satı Demir
Study officials:
affiliation: Gazi University Health Sciences Faculty, Ankara, Turkey
name: Satı Demir, PhD
role: PRINCIPAL_INVESTIGATOR
References: