Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489639
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
Sponsor:
Klaus Ranta
Organization:
Tampere University
Study Overview
Official Title:
School-based Treatment of Social Anxiety A Randomized and Controlled Study Using Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBT-DOCT-SAD
Brief Summary:
The goal of this randomized controlled trial is to find out whether the brief 10-session Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder DOCT-SAD is more effective than standard counseling SC to treat Social Anxiety Disorder SAD among 12 to 17-year-old adolescents with SAD
Potential participants for the study are identified from school health and well-being services SHWS The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS SC will be provided by non-method-trained SHWS professionals ie school nurses social workers or school psychologists according to their routine counselling practice
The main research questions of the study are
1 Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety
2 Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD
3 Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms interference in daily functioning due to worry or fears and for increasing general well-being positive mental health and for improving the quality of life among adolescents with SAD
Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents
Participants will
be treated either with DOCT-SAD or SC for 10 weeks
be followed up and assessed clinically at six-month and twelve-month follow-up points
Potential participants for the study are identified from school health and well-being services SHWS The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS SC will be provided by non-method-trained SHWS professionals ie school nurses social workers or school psychologists according to their routine counselling practice
The main research questions of the study are
1 Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety
2 Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD
3 Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms interference in daily functioning due to worry or fears and for increasing general well-being positive mental health and for improving the quality of life among adolescents with SAD
Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents
Participants will
be treated either with DOCT-SAD or SC for 10 weeks
be followed up and assessed clinically at six-month and twelve-month follow-up points
Detailed Description:
Aim
The aim of this randomized controlled trial is to investigate whether a brief 10-session intervention the Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder DOCT-SAD in Finnish Tosi minä -treeni is more effective than standard counseling SC for alleviating symptoms of social anxiety and to treat Social Anxiety Disorder SAD among adolescents identified from School Health and Well-being Services SHWS of mandatory public schools
Participants
Participants comprise of students in the grades 7-9 of the public secondary schools and students in the 1st or 2nd year-course of public high schools and vocational schools in the Tampere area of Finland They are aged from 12 to 17 years All participants will present with primary SAD according to DSM-5 criteria In total 156 students will be recruited
Procedure
Participants are identified by professionals working in the School Health and Welfare Services SHWS Recruitment is enhanced by sending information on social anxiety SAD and the research project to all SHWS professionals of the participating schools using e-mails online meetings and pre-recorded online presentations In addition families of students in the participating schools are approached with brief informative leaflets about social anxiety and the study via e-mail Potential participants for the trial will be identified in the schools using a two-stage screening and detection procedure in the SHWS and a SAD detection toolkit
In the first stage adolescents with suspected social anxiety are evaluated by SHWS professionals ie school nurses school social workers and school psychologists from their current student clients or from their new encounters with students using the SAD detection toolkit The detection toolkit consists of 1 symptom measure of social anxiety SPIN with instructions on scoring and the clinical cutoff 2 treatment suitability evaluation checklist consisting of inclusionexclusion criteria for the study in an abbreviated form and 3 pictorially enhanced one-page psychoeducation leaflet designed to help in the differentiation between core symptoms of anxiety and depression and differentiating between different types of anxiety
In the second stage the DOCT-SAD-trained school psychologists who also have been trained in diagnostic evaluation of SAD act as consultants for other SHWS professionals Once contacted by non-trained SHWS professional they discuss with them and review all information gathered The either confrirm or reject a likely diagnosis of primary SAD These DOCT-trained school psychologists refer the eligble students to the clinical research interview
The clinical intake interview
The clinicical research team evaluates the referred adolescents and assigns clinical diagnoses according DSM-5 The ADIS-5 interview schedule is used for diagnostic assessment of anxiety disorders and the associated CSR scale for is used to assess the severity of SAD and other anxiety disorders The K-SADS-PL interview schedule usis used for the diagnostic assessment of other DSM-5 disorders Subjects who present with primary SAD are asked to participate and adolescents and their parents who give their written content are taken in to the study
Randomization
After intake to the study subjects will be randomized to intervention group ie to receive DOCT-SAD delivered by the school psychologists or to comparison group ie to receive SC provided by a SHWS professional according to herhis routine professional practice For DOCT -SAD between 4 and 6 adolescents are recruited to each group randomization is performed during the school term when enough referrals
Delivery of interventions
The DOCT-SAD will be delivered by method-trained and weekly supervised school psychologists working in the SHWSs SC will be provided by non-trained SHWS professionals ie either school nurses social workers or psychologists according their routine counselling practice The school psychologists delivering the DOCT-SAD receive weekly group-based method supervision
DOCT-SAD
The DOCT-SAD is a combined individualgroup ten-session intervention for social anxiety treatment largely based largely on the cognitive therapy program CT-SAD developed in the University of Oxford UK It has been modified and theoretically expanded to address the features and challenges unique to the developmental phase of adolescence DOCT-SAD consists of four indidual and six group sessions Parents attend two of the sessions DOCT-SAD uses the main treatment components from the DOCT-SAD program derived from the cognitive model of SAD by David M Clark and Adrian Wells in 1995 These componenets include psychoeducation of SAD individualhistorical symptom formulation according to cognitive model experiential exercise on the consequences of engaging in safety behaviours attention training repeated behavioural experiments dropping of safety behaviours imagery rescripting on traumatic memories and cognitive work on beliefs
Added theoretical sources of DOCT-SAD include use of the theoretical model of core fears of social anxiety disorder being related to experienced flawsdeficiencies in the self as presented by David Moscovitch in 2009 The development of a acceptable positive self-identity is seen essential for adolescents and DOCT-SAD program makes use of original materials instuting therapist and adolescents to work on restructuring dysfunctional thoughts and emotions related to social anxiety in the context of experienced self-imageself-concept Another theoretical influence is drawn from the reseach on psychotherapeutic use of of self-compassion as an antidote to self-cricism as developed by Paul Gilbert in 2009 and applied to treatment of social anxiety by Lynne Henderson and colleagues in 2014
In DOCT-SAD programme emphasis on developmental factors is reflected in the combined individual group format of the treatment Positive peer modeling and peer support are encouraged in the group DOCT-SAD materials are developmentally informed with much emphasis given to normalization of anxiety normative fears of being deviant in the eyes of peers need for being accepted and the normative high priority given to peer opinion Group and pair exercices and out-of-office behavioural experiments are planned to encourage adolescents to practice abandoning their safety behaviors based on what they believe other people consider acceptable Brief modules to develop self-compassion are included As process adolescents work in DOCT-SAD to progress from negative self-experience self-criticism and self-concealment to being all the more their authentic self and lastly to being their authentic self and simultaneously being self-supportive in anxiety inducing social situations An empahsis is given to finding associations between adolescents SAD symptoms and their self-experience and perceived flaws and deficiencies in their their self-experience Repeated pair group and field practice of dropping of self-concealment as a safety behaviour is performed using behavioral experiments and self-exposuresand home work assignments
SC
Standard Counseling SC is an intervention consisting of counseling sessions delivered by a school health and welfare SHWS professional ie school nurse school social worker or school psychologist to support a student with social anxiety The defined length of intervention is ten weeks In SC routine professional working methods and procedures available to the SHWS professional delivering the intervention are used in the counseling
In addition to methods number of sessions treatment goals and possible involvement of parents are agreed between the counselor adolescent and parent in the same way as they are routinely agreed by the SHWS professional in herhis work with the students
Thus SC represents an intervention that is routinely delivered by a SHWS professional with a student with social anxiety
Evaluation of outcomes
The design of this trial is randomized controlled trial Participants in both intervention arms are evaluated prior to treatment at post-treatment 25 months and at 6-month and 12-month follow-up points aftter the intervention with the same methods and measures
Clinical change
Both self-report instuments SPIN SAFE PHQ-9 CALIS-C CALIS-P YP-CORE SWEMWBS WHOQOL-BREF and clinical interviews ADIS-5 with associated CSR scale K-SADS-PL are used for assessing clinical change
Feasibility of DOCT-SAD and SC
Feasibility of both DOCT-SAD and SC as interventions for the participants for their parents and for the professionals delivering the interventions is evaluated after both interventions using a structured interview schedule
Economic evaluation and additional service use
An economic evaluation of DOCT-SAD and SC includes an assessment of professionals time resource allocated for the intervention during the ten weeks and an evaluation of additional service use of the particpiants in both intervention groups The professionals delivering DOCT-SAD and SC are interviewed on the total time they have allocated to the intervention using a structured questonnaire Participants use of additional ie other than DOCT-SAD or SC healthcare and counseling services during past six months are evaluated twice first at the intake interview for the study and for the second time at 12-month follow-up point A structured survey form is used to collect the service use data
The aim of this randomized controlled trial is to investigate whether a brief 10-session intervention the Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder DOCT-SAD in Finnish Tosi minä -treeni is more effective than standard counseling SC for alleviating symptoms of social anxiety and to treat Social Anxiety Disorder SAD among adolescents identified from School Health and Well-being Services SHWS of mandatory public schools
Participants
Participants comprise of students in the grades 7-9 of the public secondary schools and students in the 1st or 2nd year-course of public high schools and vocational schools in the Tampere area of Finland They are aged from 12 to 17 years All participants will present with primary SAD according to DSM-5 criteria In total 156 students will be recruited
Procedure
Participants are identified by professionals working in the School Health and Welfare Services SHWS Recruitment is enhanced by sending information on social anxiety SAD and the research project to all SHWS professionals of the participating schools using e-mails online meetings and pre-recorded online presentations In addition families of students in the participating schools are approached with brief informative leaflets about social anxiety and the study via e-mail Potential participants for the trial will be identified in the schools using a two-stage screening and detection procedure in the SHWS and a SAD detection toolkit
In the first stage adolescents with suspected social anxiety are evaluated by SHWS professionals ie school nurses school social workers and school psychologists from their current student clients or from their new encounters with students using the SAD detection toolkit The detection toolkit consists of 1 symptom measure of social anxiety SPIN with instructions on scoring and the clinical cutoff 2 treatment suitability evaluation checklist consisting of inclusionexclusion criteria for the study in an abbreviated form and 3 pictorially enhanced one-page psychoeducation leaflet designed to help in the differentiation between core symptoms of anxiety and depression and differentiating between different types of anxiety
In the second stage the DOCT-SAD-trained school psychologists who also have been trained in diagnostic evaluation of SAD act as consultants for other SHWS professionals Once contacted by non-trained SHWS professional they discuss with them and review all information gathered The either confrirm or reject a likely diagnosis of primary SAD These DOCT-trained school psychologists refer the eligble students to the clinical research interview
The clinical intake interview
The clinicical research team evaluates the referred adolescents and assigns clinical diagnoses according DSM-5 The ADIS-5 interview schedule is used for diagnostic assessment of anxiety disorders and the associated CSR scale for is used to assess the severity of SAD and other anxiety disorders The K-SADS-PL interview schedule usis used for the diagnostic assessment of other DSM-5 disorders Subjects who present with primary SAD are asked to participate and adolescents and their parents who give their written content are taken in to the study
Randomization
After intake to the study subjects will be randomized to intervention group ie to receive DOCT-SAD delivered by the school psychologists or to comparison group ie to receive SC provided by a SHWS professional according to herhis routine professional practice For DOCT -SAD between 4 and 6 adolescents are recruited to each group randomization is performed during the school term when enough referrals
Delivery of interventions
The DOCT-SAD will be delivered by method-trained and weekly supervised school psychologists working in the SHWSs SC will be provided by non-trained SHWS professionals ie either school nurses social workers or psychologists according their routine counselling practice The school psychologists delivering the DOCT-SAD receive weekly group-based method supervision
DOCT-SAD
The DOCT-SAD is a combined individualgroup ten-session intervention for social anxiety treatment largely based largely on the cognitive therapy program CT-SAD developed in the University of Oxford UK It has been modified and theoretically expanded to address the features and challenges unique to the developmental phase of adolescence DOCT-SAD consists of four indidual and six group sessions Parents attend two of the sessions DOCT-SAD uses the main treatment components from the DOCT-SAD program derived from the cognitive model of SAD by David M Clark and Adrian Wells in 1995 These componenets include psychoeducation of SAD individualhistorical symptom formulation according to cognitive model experiential exercise on the consequences of engaging in safety behaviours attention training repeated behavioural experiments dropping of safety behaviours imagery rescripting on traumatic memories and cognitive work on beliefs
Added theoretical sources of DOCT-SAD include use of the theoretical model of core fears of social anxiety disorder being related to experienced flawsdeficiencies in the self as presented by David Moscovitch in 2009 The development of a acceptable positive self-identity is seen essential for adolescents and DOCT-SAD program makes use of original materials instuting therapist and adolescents to work on restructuring dysfunctional thoughts and emotions related to social anxiety in the context of experienced self-imageself-concept Another theoretical influence is drawn from the reseach on psychotherapeutic use of of self-compassion as an antidote to self-cricism as developed by Paul Gilbert in 2009 and applied to treatment of social anxiety by Lynne Henderson and colleagues in 2014
In DOCT-SAD programme emphasis on developmental factors is reflected in the combined individual group format of the treatment Positive peer modeling and peer support are encouraged in the group DOCT-SAD materials are developmentally informed with much emphasis given to normalization of anxiety normative fears of being deviant in the eyes of peers need for being accepted and the normative high priority given to peer opinion Group and pair exercices and out-of-office behavioural experiments are planned to encourage adolescents to practice abandoning their safety behaviors based on what they believe other people consider acceptable Brief modules to develop self-compassion are included As process adolescents work in DOCT-SAD to progress from negative self-experience self-criticism and self-concealment to being all the more their authentic self and lastly to being their authentic self and simultaneously being self-supportive in anxiety inducing social situations An empahsis is given to finding associations between adolescents SAD symptoms and their self-experience and perceived flaws and deficiencies in their their self-experience Repeated pair group and field practice of dropping of self-concealment as a safety behaviour is performed using behavioral experiments and self-exposuresand home work assignments
SC
Standard Counseling SC is an intervention consisting of counseling sessions delivered by a school health and welfare SHWS professional ie school nurse school social worker or school psychologist to support a student with social anxiety The defined length of intervention is ten weeks In SC routine professional working methods and procedures available to the SHWS professional delivering the intervention are used in the counseling
In addition to methods number of sessions treatment goals and possible involvement of parents are agreed between the counselor adolescent and parent in the same way as they are routinely agreed by the SHWS professional in herhis work with the students
Thus SC represents an intervention that is routinely delivered by a SHWS professional with a student with social anxiety
Evaluation of outcomes
The design of this trial is randomized controlled trial Participants in both intervention arms are evaluated prior to treatment at post-treatment 25 months and at 6-month and 12-month follow-up points aftter the intervention with the same methods and measures
Clinical change
Both self-report instuments SPIN SAFE PHQ-9 CALIS-C CALIS-P YP-CORE SWEMWBS WHOQOL-BREF and clinical interviews ADIS-5 with associated CSR scale K-SADS-PL are used for assessing clinical change
Feasibility of DOCT-SAD and SC
Feasibility of both DOCT-SAD and SC as interventions for the participants for their parents and for the professionals delivering the interventions is evaluated after both interventions using a structured interview schedule
Economic evaluation and additional service use
An economic evaluation of DOCT-SAD and SC includes an assessment of professionals time resource allocated for the intervention during the ten weeks and an evaluation of additional service use of the particpiants in both intervention groups The professionals delivering DOCT-SAD and SC are interviewed on the total time they have allocated to the intervention using a structured questonnaire Participants use of additional ie other than DOCT-SAD or SC healthcare and counseling services during past six months are evaluated twice first at the intake interview for the study and for the second time at 12-month follow-up point A structured survey form is used to collect the service use data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None