Emotional DistressNCT06436521

The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy

A study testing Positive Cognitive Behavioral Therapy and Traditional Cognitive Behavioral Therapy in people with Emotional Distress and Well-Being, Psychological, run by Babes-Bolyai University at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Emotional Distress, Well-Being, Psychological, Performance
What is being tested?: Positive Cognitive Behavioral Therapy and Traditional Cognitive Behavioral Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteRomania
Study dates: Oct 2014to Mar 2015
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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Students in the master's program in psychology

Who cannot join

Trial locations and contacts

1 site in 1 country.

Romania1 site

Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University
Cluj-Napoca, Cluj, 40015

Other trials in Romania

About this study

Official title: The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy on Improving Well-Being and Goal Attainment in Young Adults

Positive Cognitive Behavioral Therapy (P-CBT) has emerged as the fourth Cognitive Behavioral Therapy waive, based on critiques brought to Cognitive Behavioral Therapy for being grounded in the deficit-based medical model. The study aim to identify which of the two Cognitive Behavioral Therapy approaches, Positive or Traditional, is more effective in a brief format in terms of improving emotional state, attaining goals, and changing attitudes in young adults.

Read the detailed description

This study is a randomized controlled trial that aims to explore the effectiveness of two Cognitive Behavioral approaches: Positive and Traditional, in terms of improving emotional state, attaining goals, and changing attitudes in young adults. Thirty-eight participants divided into two groups, received four therapy sessions for four weeks. The outcomes were measured four times: pre-, mid- (after two sessions), post-intervention (after four sessions), and at two-month follow-up.

Conditions: Emotional Distress, Well-Being, Psychological, Performance
Being tested: Positive Cognitive Behavioral Therapy, Traditional Cognitive Behavioral Therapy
Keywords: Solution-focused, Problem-solving, Positive CBT, Traditional CBT, Well-being
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive Cognitive Behavioral TherapyBehavioural
Positive CBT integrates brief Solution-Focused Brief Therapy with Positive Psychology techniques, within a cognitive-behavioral framework. It is considered a competency and strengths-based model.
Traditional Cognitive Behavioral TherapyBehavioural
Traditional cognitive behavioral therapy is a form of psychological treatment that emphasizes that psychological problems are based on faulty or unhelpful ways of thinking and the focus is to change thinking patterns.

Study groups in NCT06436521
Study group	Role	What they receive
Positive CBT (P-CBT)	Experimental	Participants received P-CBT intervention after a standard protocol. The intervention used Solution-focused questioning. Receives: Behavioral: Positive Cognitive Behavioral Therapy
Traditional CBT (T-CBT)	Experimental	Participants received T-CBT intervention after a standard protocol. The intervention used Problem-solving questioning. Receives: Behavioral: Traditional Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Distress
The level of negative emotions, measured with Profile of Affective Distress plus. The items are ranked with a 5-point Likert scale. Higher scores mean a worse outcome.
Measured: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.
Positive Emotions
The level of positive emotions, measured with Profile of Affective Distress plus; The items are ranked with a 5-point Likert scale.Higher scores mean a better outcome.
Measured: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.
Performance
Performance was measured using a Visual Analogue Scale -type item. The outcome had a one-item ranging from 1 to 10. Participants had to assess the statement: - How close are you to solving the problem/attaining your goal? Higher scores mean a better outcome.
Measured: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Attitude towards problems
Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
Measured: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Attitude towards goals
Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
Measured: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Attitude towards resources
Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
Measured: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Mar 2015

First posted31 May 2024
Study startOct 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Emotional DistressStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants were assigned to one approach: Positive CBT or Traditional CBT, through simple randomization.
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06436521
Sponsor's protocol ID: MDStudy
Status last verified: Mar 2024
First submitted: 22 Mar 2024
Last updated: 31 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bannink, F. (2012). Practicing positive CBT: From reducing distress to building success. John Wiley & Sons https://doi.org/10.1002/9781118328941
Bannink, F., & Geschwind, N. (2021). , Positive CBT: Individual and Group Treatment Protocols for Positive Cognitive Behavioral Therapy. In Positive CBT: Individual and Group Treatment Protocols for Positive Cognitive Behavioral Therapy. https://doi.org/10.1027/00578-000
Bhattacharya S, Goicoechea C, Heshmati S, Carpenter JK, Hofmann SG. Efficacy of Cognitive Behavioral Therapy for Anxiety-Related Disorders: A Meta-Analysis of Recent Literature. Curr Psychiatry Rep. 2023 Jan;25(1):19-30. doi: 10.1007/s11920-022-01402-8. Epub 2022 Dec 19.
PubMed 36534317
Braunstein, K., & Grant, A. M. (2016). Approaching solutions or avoiding problems? The differential effects of approach and avoidance goals with solution-focused and problem-focused coaching questions. Coaching, 9(2). https://doi.org/10.1080/17521882.2016.1186705
Cohen, J. (1988a). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates.
Cuijpers P, Miguel C, Harrer M, Plessen CY, Ciharova M, Ebert D, Karyotaki E. Cognitive behavior therapy vs. control conditions, other psychotherapies, pharmacotherapies and combined treatment for depression: a comprehensive meta-analysis including 409 trials with 52,702 patients. World Psychiatry. 2023 Feb;22(1):105-115. doi: 10.1002/wps.21069.
PubMed 36640411
de Boer AG, van Lanschot JJ, Stalmeier PF, van Sandick JW, Hulscher JB, de Haes JC, Sprangers MA. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004 Mar;13(2):311-20. doi: 10.1023/B:QURE.0000018499.64574.1f.
PubMed 15085903
De Shazer, S., & Berg, I. K. (1997). "What works?" Remarks on research aspects of Solution-Focused Brief Therapy. Journal of Family Therapy, 19(2). https://doi.org/10.1111/1467-6427.00043
De Shazer S, Berg IK, Lipchik E, Nunnally E, Molnar A, Gingerich W, Weiner-Davis M. Brief therapy: focused solution development. Fam Process. 1986 Jun;25(2):207-21. doi: 10.1111/j.1545-5300.1986.00207.x.
PubMed 3732502
Erbe D, Eichert HC, Riper H, Ebert DD. Blending Face-to-Face and Internet-Based Interventions for the Treatment of Mental Disorders in Adults: Systematic Review. J Med Internet Res. 2017 Sep 15;19(9):e306. doi: 10.2196/jmir.6588.
PubMed 28916506
Geschwind N, Arntz A, Bannink F, Peeters F. Positive cognitive behavior therapy in the treatment of depression: A randomized order within-subject comparison with traditional cognitive behavior therapy. Behav Res Ther. 2019 May;116:119-130. doi: 10.1016/j.brat.2019.03.005. Epub 2019 Mar 9.
PubMed 30897464
Grant, A. M. (2012). Making Positive Change: A Randomized Study Comparing Solution-Focused vs. Problem-Focused Coaching Questions. Journal of Systemic Therapies, 31(2). https://doi.org/10.1521/jsyt.2012.31.2.21
Grant, A. M., & O'Connor, S. A. (2010). The differential effects of solution-focused and problem-focused coaching questions: A pilot study with implications for practice. Industrial and Commercial Training, 42(2). https://doi.org/10.1108/00197851011026090
Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
PubMed 23459093
Padesky CA, Mooney KA. Strengths-based cognitive-behavioural therapy: a four-step model to build resilience. Clin Psychol Psychother. 2012 Jul-Aug;19(4):283-90. doi: 10.1002/cpp.1795. Epub 2012 Jun 1.
PubMed 22653834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction

All Emotional Distress trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy on Improving Well-Being and Goal Attainment in Young Adults
ClinicalTrials.gov ID: NCT06436521
Acronym / sponsor ID: MDStudy
Conditions: Emotional Distress, Well-Being, Psychological, Performance
Keywords: Solution-focused, Problem-solving, Positive CBT, Traditional CBT, Well-being
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Babes-Bolyai UniversityUniversity, hospital or other
Study start: Oct 2014 (actual)
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 31 May 2024 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants were assigned to one approach: Positive CBT or Traditional CBT, through simple randomization.

Arm	Type	Receives
Positive CBT (P-CBT)	Experimental	Behavioral: Positive Cognitive Behavioral TherapyParticipants received P-CBT intervention after a standard protocol. The intervention used Solution-focused questioning.
Traditional CBT (T-CBT)	Experimental	Behavioral: Traditional Cognitive Behavioral TherapyParticipants received T-CBT intervention after a standard protocol. The intervention used Problem-solving questioning.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Students in the master's program in psychology

Key exclusion criteria (1 listed)

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
Positive Cognitive Behavioral TherapyPositive CBT integrates brief Solution-Focused Brief Therapy with Positive Psychology techniques, within a cognitive-behavioral framework. It is considered a competency and strengths-based model.	Behavioural	Positive CBT (P-CBT)
Traditional Cognitive Behavioral TherapyTraditional cognitive behavioral therapy is a form of psychological treatment that emphasizes that psychological problems are based on faulty or unhelpful ways of thinking and the focus is to change thinking patterns.	Behavioural	Traditional CBT (T-CBT)

Primary outcome

Distress
Time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.
The level of negative emotions, measured with Profile of Affective Distress plus. The items are ranked with a 5-point Likert scale. Higher scores mean a worse outcome.
Positive Emotions
Time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.
The level of positive emotions, measured with Profile of Affective Distress plus; The items are ranked with a 5-point Likert scale.Higher scores mean a better outcome.
Performance
Time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Performance was measured using a Visual Analogue Scale -type item. The outcome had a one-item ranging from 1 to 10. Participants had to assess the statement: - How close are you to solving the problem/attaining your goal? Higher scores mean a better outcome.
Attitude towards problems
Time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
Attitude towards goals
Time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
Attitude towards resources
Time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.

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 31 May 2024.
BackgroundBannink, F. (2012). Practicing positive CBT: From reducing distress to building success. John Wiley & Sons https://doi.org/10.1002/9781118328941
BackgroundBannink, F., & Geschwind, N. (2021). , Positive CBT: Individual and Group Treatment Protocols for Positive Cognitive Behavioral Therapy. In Positive CBT: Individual and Group Treatment Protocols for Positive Cognitive Behavioral Therapy. https://doi.org/10.1027/00578-000
Background: PubMed 36534317Bhattacharya S, Goicoechea C, Heshmati S, Carpenter JK, Hofmann SG. Efficacy of Cognitive Behavioral Therapy for Anxiety-Related Disorders: A Meta-Analysis of Recent Literature. Curr Psychiatry Rep. 2023 Jan;25(1):19-30. doi: 10.1007/s11920-022-01402-8. Epub 2022 Dec 19.
BackgroundBraunstein, K., & Grant, A. M. (2016). Approaching solutions or avoiding problems? The differential effects of approach and avoidance goals with solution-focused and problem-focused coaching questions. Coaching, 9(2). https://doi.org/10.1080/17521882.2016.1186705
BackgroundCohen, J. (1988a). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates.
Background: PubMed 36640411Cuijpers P, Miguel C, Harrer M, Plessen CY, Ciharova M, Ebert D, Karyotaki E. Cognitive behavior therapy vs. control conditions, other psychotherapies, pharmacotherapies and combined treatment for depression: a comprehensive meta-analysis including 409 trials with 52,702 patients. World Psychiatry. 2023 Feb;22(1):105-115. doi: 10.1002/wps.21069.
Background: PubMed 15085903de Boer AG, van Lanschot JJ, Stalmeier PF, van Sandick JW, Hulscher JB, de Haes JC, Sprangers MA. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004 Mar;13(2):311-20. doi: 10.1023/B:QURE.0000018499.64574.1f.
BackgroundDe Shazer, S., & Berg, I. K. (1997). "What works?" Remarks on research aspects of Solution-Focused Brief Therapy. Journal of Family Therapy, 19(2). https://doi.org/10.1111/1467-6427.00043
Background: PubMed 3732502De Shazer S, Berg IK, Lipchik E, Nunnally E, Molnar A, Gingerich W, Weiner-Davis M. Brief therapy: focused solution development. Fam Process. 1986 Jun;25(2):207-21. doi: 10.1111/j.1545-5300.1986.00207.x.
Background: PubMed 28916506Erbe D, Eichert HC, Riper H, Ebert DD. Blending Face-to-Face and Internet-Based Interventions for the Treatment of Mental Disorders in Adults: Systematic Review. J Med Internet Res. 2017 Sep 15;19(9):e306. doi: 10.2196/jmir.6588.
Background: PubMed 30897464Geschwind N, Arntz A, Bannink F, Peeters F. Positive cognitive behavior therapy in the treatment of depression: A randomized order within-subject comparison with traditional cognitive behavior therapy. Behav Res Ther. 2019 May;116:119-130. doi: 10.1016/j.brat.2019.03.005. Epub 2019 Mar 9.
BackgroundGrant, A. M. (2012). Making Positive Change: A Randomized Study Comparing Solution-Focused vs. Problem-Focused Coaching Questions. Journal of Systemic Therapies, 31(2). https://doi.org/10.1521/jsyt.2012.31.2.21
Individual participant dataSharing planned: No

Related trials for Emotional Distress

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction

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.

Loana T Comsa, Ph.D. principal investigator

Babes-Bolyai University Cluj-Napoca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 31 May 2024. 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 Romania. 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?

Distress (time frame: Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06436521, which also lists 18 linked publications.

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 31 May 2024.