Study related to the effect of Cognitive Behavioral Therapy for insomnia on depression and suicide

Clinical trial related to the effectiveness of TCCI on depressive symptoms and suicidal behavior - CBTI Cognitive behavioral therapy for insomnia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-10b889rz

Enrollment

Unknown

Registered

2023-02-13

Start date

2022-01-03

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

This is a randomized, double-blind, controlled clinical trial conducted over 8 weeks, with a sample of 40 participants. Individuals aged 18 to 60 years, diagnosed with depression and insomnia symptoms

Experimental Group: 20 participants who will undergo amitriptyline medication at a dosage of 1 pill 25 mg (Oral) for insomnia and intervention with Cognitive Behavioral Therapy for Insomnia with a pro

G07.690.773.875

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Minimum age of 18 years and maximum of 60 years; meet Diagnostic and Statistical Manual for Mental Disorders criteria (DSM-V Criteria) for Depressive Disorder and comorbid insomnia; suicidal behavior according to the criteria proposed by the Columbia Suicide Risk Assessment Scale.

Exclusion criteria

Exclusion criteria: Do not meet the criteria for comorbid insomnia and major depression; Cognitive impairment (Mini Mental State Examination); Make changes to psychotropic medications within 4 weeks of the start of the trial and/or changes made throughout treatment; Present other psychiatric comorbidities such as Schizophrenia, Bipolar Affective Disorder and Anxiety Disorders previously evaluated by the Neurocognition outpatient service of Pernambuco Institute of Integral Medicine; Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Expected that the reduction of suicidal ideation through the pharmacological treatment of insomnia associated with specific psychotherapeutic intervention should prove to be more effective in improving the psychiatric condition, rather than the isolated use of medication, especially in individuals undergoing outpatient treatment. These results may support the understanding that CBT may be a promising intervention to reduce the risk of suicide among individuals with insomnia and depression. In addition to the fact that CBT is also free of risks commonly associated with pharmacotherapy, such as drug interactions and overdoses. Thus, it is expected that if CBT can reduce behavior, it will be possible to include this safe and relatively inexpensive treatment as a relevant strategy for the prevention of suicide deaths.	—

Measure

Time frame

Expected that the reduction of suicidal ideation through the pharmacological treatment of insomnia associated with specific psychotherapeutic intervention should prove to be more effective in improving the psychiatric condition, rather than the isolated use of medication, especially in individuals undergoing outpatient treatment. These results may support the understanding that CBT may be a promising intervention to reduce the risk of suicide among individuals with insomnia and depression. In addition to the fact that CBT is also free of risks commonly associated with pharmacotherapy, such as drug interactions and overdoses. Thus, it is expected that if CBT can reduce behavior, it will be possible to include this safe and relatively inexpensive treatment as a relevant strategy for the prevention of suicide deaths.

—

Secondary

Measure	Time frame
Secondary outcomes are not expected.	—

Countries

Brazil

Contacts

Public ContactDennys Fagundes

Universidade Federal de Pernambuco

faleconosco@ufpe.br+55 (81) 2126.8000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)