Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000847718
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
16/06/2022
Date last updated
26/09/2022
Date data sharing statement initially provided
16/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A process-based psychological treatment informed by relational frame theory for people who meet criteria for multiple psychiatric disorders
Scientific title
Verbal Behavior Analysis informed by Relational Frame Theory on a comorbid sample within the areas of depression, anxiety and Obsessive Compulsive Disorder - A mixed methods design with multiple baseline design with six clients and interpretative phenomenological analysis to test feasibility, acceptability and effectiveness.
Secondary ID [1] 303250 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 320440 0
Panic Disorder 320441 0
Agora Phobia 320442 0
Social Anxiety Disorder 320443 0
Obsessional Compulsive Disorder 320444 0
Post-Traumatic Stress Disorder 320445 0
Generalised Anxiety Disorder 320446 0
Condition category
Condition code
Mental Health 318336 318336 0 0
Anxiety
Mental Health 318337 318337 0 0
Depression
Mental Health 318338 318338 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates a psychological treatment (verbal functional analysis) informed by Relational Frame Theory (RFT) on a comorbid sample within the areas of depression, anxiety and obsessive compulsive disorder (OCD)

Participants meet therapists face-to-face individually at a health care center or a psychiatric outpatient clinic depending on the region of inclusion, for maximum 30 consecutive weeks, 1-2 sessions a week, one hour at the time.

The treatment is idiographical and principle based (operant learning according to an updated account of relational frame theory). The instruments for measuring the process aim to assess and influence participants maladaptive relating around themselves and others.

Note that the following text include behavioral concepts from modern relational frame theory that may seem foreign or strange. Even though examples are routinely offered, a complete elaboration or translation is not be viable in this context. The following article may aid readers not accustomed to relational frame theory and the particular behavioral language accompanying it: Barnes-Holmes, D., Barnes-Holmes, Y., & McEnteggart, C. (2020). Updating RFT (more field than frame) and its implications for process-based therapy. The Psychological Record, 1-20.

Key properties of patterns of verbal behavior are assessed through dialogue throughout the treatment.

Clients often come into therapy asserting a specific problem (e.g., “I feel depressed”). These approached self-labels may also possess avoidance functions of safety, justification, or comfort relative to a more distressing or aversive relational network (.e.g. I’m worthless or unlovable). As such, these seemingly aversive verbal stimuli (“I’m depressed”) have relatively appetitive functions. When conducting a verbal functional analysis, we assess both relatively appetitive and relatively aversive relational networks. That is, appetitive networks have dominant approach or S+ functions (approached), while more aversive networks have dominant avoidance or S- functions (avoided).

A key part of the verbal functional analysis involves identifying the relationship between the deictic-I network (i.e., the network through which the perspective I-HERE-NOW emerge) and the S+ and S- networks. This assessment is conducted in parallel to the assessment of the S+ and S- networks and offers guidance on whether there is a stable deictic-I from which the client responds. In essence, assessing the deictic-I involves assessing how that network is related to other networks. For example, is the client’s deictic-I completely coordinated with a certain network in which there are no instances of choosing hierarchically (e.g., “I am completely hopeless so there is no point at all to try that again” vs. “I notice discouraging thoughts and feelings and I must choose what to do in their presence). Said in other words, the therapist and the client build a new narrative about the client and the old narrative to facilitate adaption.

The therapist actively engages in building a strong therapeutic relationship with the client. The therapist engages in creating coordinated narratives with the client allowing for derivations such as “my therapist understand and care about me, maybe I’m not completely hopeless after all”. Relating between the deictic-I and deictic-Others is promoted by validating the client’s narrative which involves both reflecting what has been said and in addition the therapist needs to make sure the client experiences a shared understanding and a witness to the narrative of why the client did what they did, what they experienced, in specific situations. The therapist offers contextual cues for hierarchical relating between the deictic-I and the narrative that exercises control as well as for the coordinating of narratives between the therapist and the client with phrases such as “sitting here now, hearing how it all played out back then, I can see how frustrated you must have been. If I was in your shoes, I would have felt that too”. A therapeutic relationship that is stable, predictable and consistent is essential for altering functions in previously avoided networks. The therapist should provide a highly shared and cooperative context over a longer time when needed so that a more stable coherent deictic-I may be established. If the clients deictic-I is coherent and basically hierarchically situated, but present circumstances move the deictic-I to relate to events in a non-hierarchical relation (e.g., coordination), then, shorter time may be needed to re-establish a stable deictic-I as described above.

In establishing verbal tracking of the causal relations between the deictic-I and other relational networks (e.g., S+ and S-), it is essential that these two sets of networks (i.e. the deictic-I and S+ / S-) come to participate in a hierarchical relation. Specifically, the network of the deictic-I should contain the networks that relate causally to behavior. The deictic-I can then “choose” how to behave. Ultimately, clients are not relating to themselves as victims of their context, but as capable of choosing directions of their lives, even in the presence of intrusive thoughts and pain.

Once the S- network has been identified, we orient very carefully toward it, as this will likely challenge the therapeutic relationship. At this point, the coherence within the S+ and S- networks are high but they aren’t related (e.g., the client does not see how “I must over-perform” participates in a relationship with “I’m worthless), so the therapist aims to help the client relate the two networks in order to allow for transformation of functions within the networks (i.e. it may no longer make sense to over-perform when it mainly serves to prove that one is not worthless yet ironically facilitates it over and over again. This is achieved by establishing causal relations between these two networks. For example, the therapist might say “it must be truly exhausting to put so much energy into always proving that you are not worthless? A little like scooping water from a boat in order to prove that it’s not sinking instead of dealing with the holes and get to sailing?”. For the client, this statement relates the S+ and S- networks facilitating a transfer of the less aversive functions of the S+ network to the more aversive S- network, in so far as the client becomes more willing to talk about rejection and worthlessness. To further this move, the therapist might say, for example, “What if rejection lay at the end of this line of overperforming? What if overperforming and everything that comes with it actually hurt your relationships? If you had to choose between proving that you are great and having genuine relationships, which one would you choose?” Doing this facilitates a strong therapeutic relationship that allows the therapist to focus on issues that may be highly sensitive and deeply entangled in the client’s history and current situation, and which if broached too early in therapy could undermine the relationship. In a more general way, getting clients to engage with issues they have tended to avoid is important for moving toward building successful tracking of sources of behavioral control.

Both therapists in this study are licensed psychologists with minimum 7 years experience, whereas one phd and one graduate student, both in clinical psychology and with a background in behavior therapy/contextual behavioural science and relational frame theory.
Intervention code [1] 319561 0
Behaviour
Intervention code [2] 323259 0
Treatment: Other
Comparator / control treatment
Participants serve as their own control condition in single case experimental designs. The baseline measurements are compared to the measurements done during the intervention phase. The baseline length is randomised between 7 and 21 days.
Control group
Active

Outcomes
Primary outcome [1] 326306 0
Daily idiographic assessment (DIA)
The daily idiographic assessments (DIA) consists of four questions that assess the participants relating, orienting evoking functions and verbal tracking inferred from relational fram theory. The scale was designed specifically for this study.

CONSIDER THE LAST DAY

Orienting

How often do the things that you are trying to work through come to mind?
0 = Not at all often - 10 = All the time


Relating

Describe below the issues, struggles or difficulties that you have spent most time trying to resolve?
textbox


Evoking

How willing would you be to tell numerous people you know about the things that you are trying to figure out?
0 = Not at all willing - 10 = completely willing


Verbal tracking

In addition to your struggle, do you believe that you have enough headspace and energy to comfortably manage other aspects of your life?
0 = No space at all - 10. Plenty of space
Timepoint [1] 326306 0
Daily measures during baseline phase (7-21 days prior to treatment), during treatment phase (30 weeks) and one week post treatment as well as one week during follow-up measurements at 2 and 6 months. I.e., the daily measures will not occur between one week after the treatment has ended and until the first follow-up measurements are conducted. Also, they will not occur between the first and the second follow-up measurement phase.
Primary outcome [2] 330931 0
Weekly idiographic assessment (WIA)
The weekly idiographic assessment consists of 6 questions that assess shifts in the dimensions of relating and choice inferred from relational frame theory.
The scale was designed specifically for this study.

CONSIDER THE LAST WEEK

Flexibility

Do you always think the same way about what you are trying to sort out?
0 = No, it differs from context to context - 10 = Yes, in all contexts


Complexity

If you were given the task of describing what you are trying to sort out in an understandable way, how much space would you need then?
0 = A few words would suffice - 10 = Very many words would be required


Derivation

Has anything new come up, that makes you look at what you are trying to sort out in a different way?
0 = no, not at all - 10 = very much new has been added


Coherence

Have you figured out (or found) that something you previously thought about X might not be true?
0 = No, not at all - 10 = Yes, all


Valued action (Choice)

Have you noticed any experiences, behaviours or even just thoughts and feelings that you had this week that seemed different to you?
0 = Not at all - 10 = Yes, everything is different now

Describe (concisely) what has been different:
textbox
Timepoint [2] 330931 0
Weekly measures during baseline phase (7-21 days prior to treatment), during treatment phase (30 weeks) and once post treatment as well as once during follow-up measurements at 2 and 6 months. I.e., the weekly measures will not occur between one week after the treatment has ended and until the first follow-up measurements are conducted. Also, they will not occur between the first and the second follow-up measurement.
Secondary outcome [1] 391001 0
The Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) is used to assess for symptoms of depression.
Timepoint [1] 391001 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [2] 408130 0
The Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006) is used to assess for symptoms of anxiety.
Timepoint [2] 408130 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [3] 408131 0
The Brunnsviken Brief Quality of Life Scale (BBQ; Lindner et al., 2016) is used to assess for quality of life.
Timepoint [3] 408131 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [4] 408132 0
ALIVE is used to assess psychological flexibility, 5 item scale, (Bond & Dowling personal Communication, 2019)
Timepoint [4] 408132 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [5] 408133 0
The Liebowitz Social Anxiety Scale - Self Report (LSAS-SR; Baker, Heinrichs, Kim, & Hofmann, 2002) assesses symptoms among those with social anxiety disorder.
Timepoint [5] 408133 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [6] 408134 0
The Yale-Brown Obsessive Compulsive Scale (YBOCS; Goodman et al., 1989) assesses symptoms among those with OCD.
Timepoint [6] 408134 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [7] 408135 0
The Posttraumatic Stress Disorder Checklist (PCL; Blevins, Weathers, Davis, Witte, & Domino, 2015) assesses symptoms for those with PTSD.
Timepoint [7] 408135 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [8] 408136 0
The Negative Effects Questionnaire (NEQ; Rozental et al., 2019) is used to assess negative effects of psychological treatments, administered only at the end of treatment.
Timepoint [8] 408136 0
Pre, post (30 weeks post-intervention commencement), and follow-up at 2 and 6 months post-intervention completion
Secondary outcome [9] 408137 0
The Credibility expectancy questionnaire (CEQ; Devilly & Borkovec, 2000) assess treatment credibility and expectancy,
Timepoint [9] 408137 0
Administered at session 5 only.
Secondary outcome [10] 408138 0
Semi structured interview:

Interview guide
We are interested in your experience of the treatment

1) How have you experienced the treatment?
- how did you feel during the treatment?
- how did your mood change during the treatment?

2) Has anything changed for you during the treatment?
- has anything in your everyday life changed since you started the treatment? if yes: what / how?
- are you doing anything different since you started treatment? if so, what?
- how do you think people close to you would respond if we asked them if anything had changed with you since you started treatment?
- do you think differently in any way since you started treatment?
o How do you think about yourself and others today compared to before you started treatment?
o do you think noticeably more or less about something in particular today compared to before the treatment started? if so, what?
o How do you think about responsibility and your ability to influence your situation today compared to before you started treatment?
o How do you think about the future today compared to before you started treatment?
- did you learn anything new during the treatment? If yes: what?
- has something gotten worse or more difficult for you since the treatment started? if so, what?
- has anything gotten better or easier for you since the treatment started? if so, what?
- if something has changed: what, inside and outside the treatment, do you think may have influenced the change / changes?

3) What was helpful with the treatment?

4) What was difficult during the treatment?
- was anything painful during the treatment?
- was something difficult to understand about the treatment itself?

5). To what extent did you feel confident in a) the treatment and b) the therapist?
- how did the confidence in the treatment and the therapist vary during the course of the treatment?

7) Would you recommend anyone else to go for this treatment?
If not, what are the main reasons?
If so: what are the main reasons?
o What recommendations would you give to someone else who has been offered to go for this type of treatment?
8) Is there anything you wish would have been different with the treatment?
9) Is there anything that you think is important for us to know about what it has been like for you to participate in the study / treatment, which we have not yet talked about?
Timepoint [10] 408138 0
Post treatment (30 weeks after treatment start)
Secondary outcome [11] 410758 0
Adherence

Adherence are tracked by the therapist who takes notes on missed visits and rebooking session by session
Timepoint [11] 410758 0
continuously during treatment

Eligibility
Key inclusion criteria
(1) participant is at least 18 years of age and
(2) have a minimum of two comorbid psychiatric disorders within anxiety disorders, obsessive-compulsive disorder and depression.
(3) if regular pharmacological treatment for anxiety, obsessive-compulsive disorder, depression and eating disorder occurs, participation require stable doses for at least two months before the start of the measurements is allowed.
(4) participants must have undergone conventional treatment for one of their current
diagnoses previously.
(5) fluent in Swedish
(6) have access to internet and able to use smartphone or computer
(7) able to attend sessions on regular weekdays (9-5pm) 1-2 times a week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) other ongoing psychological treatment,
(2) factors that appear that cause a new treatment to be considered inappropriate, eg., ongoing manic or psychotic episode, alcohol or substance abuse as well as other problems that suggest other treatments as first choice,
(3) increased suicide risk emerged from item 9 on Montgomery Åsberg Depression Rating Scale (MADRS-S; Svanborg & Åsberg, 1994; 4 points or more) and
(4) persons with a total score of over 34 points (severe depression) on MADRS-S.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A single case experimental (multiple baseline) design (SCED) with six baselines and randomized baseline lengths (7-21 days)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Visual analysis, randomisations tests of repeated data and Interpretative Phenomenological Analysis from post treatment interview data

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/09/2022
Actual
7/09/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
6
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 23408 0
Sweden
State/province [1] 23408 0
Falun and Stockholm

Funding & Sponsors
Funding source category [1] 307659 0
University
Name [1] 307659 0
Karlstad University
Country [1] 307659 0
Sweden
Funding source category [2] 307674 0
University
Name [2] 307674 0
Karolinska Institutet
Country [2] 307674 0
Sweden
Funding source category [3] 307675 0
Government body
Name [3] 307675 0
Region stockholm
Country [3] 307675 0
Sweden
Primary sponsor type
Government body
Name
Kompetenscentrum för psykoterapi, Centrum för psykitriforskning
Address
Sweden, Liljeholmstorget 7, 117 63 Stockholm
Country
Sweden
Secondary sponsor category [1] 308372 0
None
Name [1] 308372 0
Address [1] 308372 0
Country [1] 308372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307697 0
Etikprövningsmyndigheten
Ethics committee address [1] 307697 0
Ethics committee country [1] 307697 0
Sweden
Date submitted for ethics approval [1] 307697 0
18/05/2021
Approval date [1] 307697 0
21/06/2021
Ethics approval number [1] 307697 0
2019-06346, 2021-02778, 2022-03382-02-289958

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108182 0
Dr Thomas Parling
Address 108182 0
Kompetenscentrum för psykoterapi, Centrum för psykiatriforskning
Liljeholmstorget 7, 117 63 Stockholm, Sweden
Country 108182 0
Sweden
Phone 108182 0
+46702058007
Fax 108182 0
Email 108182 0
Thomas.parling@ki.se
Contact person for public queries
Name 108183 0
Thomas Parling
Address 108183 0
Kompetenscentrum för psykoterapi, Centrum för psykiatriforskning
Liljeholmstorget 7, 117 63 Stockholm, Sweden
Country 108183 0
Sweden
Phone 108183 0
+46702058007
Fax 108183 0
Email 108183 0
Thomas.parling@ki.se
Contact person for scientific queries
Name 108184 0
Thomas Parling
Address 108184 0
Kompetenscentrum för psykoterapi, Centrum för psykiatriforskning
Liljeholmstorget 7, 117 63 Stockholm, Sweden
Country 108184 0
Sweden
Phone 108184 0
+46702058007
Fax 108184 0
Email 108184 0
Thomas.parling@ki.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Because of the small number of participants, the risk of violation of integrity is to high


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10342Ethical approval  registrator@etikprovning.se 381281-(Uploaded-26-01-2021-22-28-47)-Study-related document.pdf
16250Study protocol  thomas.parling@ki.se
16251Informed consent form  thomas.parling@ki.se



Results publications and other study-related documents

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